11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details


臨床試験数 : 332 薬物数 : 234 - (DrugBank : 81) / 標的遺伝子数 : 45 - 標的パスウェイ数 : 127

  
157 trials found
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PhaseCountries
1NCT05390840
(ClinicalTrials.gov)
August 202220/5/2022A Study to Investigate the Effect on Central Macular Thickness of Treatment With MG-O-1002 Eye Drops in Participants Aged Over 45 With Neovascular Age-related Macular Degeneration (nAMD)A Phase II Trial to Evaluate the Efficacy and Safety of Topical Ocular MG-O-1002 in Patients With Neovascular Age-Related Macular Degeneration (nAMD)Age-Related Macular DegenerationDrug: MG-O-1002;Other: PlaceboTheratocular Biotek Co.NULLNot yet recruiting45 YearsN/AAll36Phase 2NULL
2NCT05067348
(ClinicalTrials.gov)
July 21, 202223/9/2021Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled Clinical Trial of the Efficacy and Safety of Tocilizumab in the Treatment of Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Tocilizumab Injectable ProductTang-Du HospitalNULLRecruiting18 Years80 YearsAll64Phase 2China
3NCT05403541
(ClinicalTrials.gov)
June 27, 202226/5/2022Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia GravisA Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis (gMG)Generalized Myasthenia GravisDrug: Batoclimab 680 mg SC weekly;Drug: Batoclimab 340 mg SC weekly;Drug: Matching Placebo SC;Drug: Batoclimab 340 mg SC bi-weeklyImmunovant Sciences GmbHNULLRecruiting18 YearsN/AAll210Phase 3United States;Georgia;Italy;Poland;Romania
4JPRN-jRCT2021210024
15/02/202230/07/2021A PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVISA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Myasthenia GravisSatralizumab: 120 mg or 180mg SC injection every 4 weeks (Q4W)Ivana VodopivecNULLRecruiting>= 12age oldNot applicableBoth240Phase 3United States;Argentina;Australia;Brazil;Canada;China;Denmark;France;Germany;Italy;Republic of Korea;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey;Japan
5EUCTR2021-001229-26-ES
(EUCTR)
21/01/202214/12/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: ALXN2050
INN or Proposed INN: N/A
Other descriptive name: (1R,3S,5R)-2-(2-(3-acetyl-5-(2-methylpyrimidin-5-yl)-1H-indazol-1-yl)acetyl)-N-(6-bromo-3-methylpyridin-2-yl)-5-methyl-2-azabicyclo[3.1.0]hexane-3-carboxamide
Alexion PharmaceuticalsNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Korea, Democratic People's Republic of;Germany;Italy
6JPRN-jRCT2021210027
20/01/202213/08/2021A Study of Nipocalimab Administered to Adults with Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia GravisNipocalimab (JNJ-80202135, M281)
Double-blind Placebo-controlled Phase: Participants will receive nipocalimab intravenous (IV) infusions once every 2 weeks (q2w) up to 24 weeks during double-blind placebo-controlled phase. Open-label Extension (OLE) Phase: Participants who complete the double-blind placebo-controlled phase will enter the OLE phase and continue to receive nipocalimab q2w IV infusion from OLE Day 1 to 24 weeks. Participants who are stable on the q2w dosing regimen can be transitioned to a dosing regimen every 4 weeks (q4w) during OLE phase

Placebo
Double-blind Placebo-controlled Phase: Participants will receive matching placebo of nipocalimab IV infusion q2w up to 24 weeks during double-blind placebo-controlled phase.
Nakano MasayoshiNULLPending>= 18age oldNot applicableBoth180Phase 3Belgium;Canada;China;Colombia;Czechia;Germany;Denmark;Spain;France;Kingdom Of Great Britain And Northern Ireland;Italy;Mexico;Poland;Russian Federation;Sweden;Turkey;United States Of America;Japan
7EUCTR2020-005732-29-DK
(EUCTR)
13/01/202225/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
8EUCTR2021-003898-59-ES
(EUCTR)
12/01/202214/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Poland;Spain;Russian Federation;Germany;United Kingdom;Italy;Japan;China
9EUCTR2021-003898-59-PL
(EUCTR)
11/01/202225/11/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutinib
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLNot RecruitingFemale: yes
Male: yes
192Phase 3United States;Czechia;Spain;Russian Federation;United Kingdom;Italy;Hungary;Mexico;Canada;Argentina;Poland;Brazil;Germany;China;Japan
10NCT04982289
(ClinicalTrials.gov)
January 1, 202221/6/2021Study of ALXN1830 Administered Subcutaneously in Adults With Generalized Myasthenia GravisA Phase 2a Randomized, Double-blind, Placebo-controlled, Parallel Groups, Multicenter Study to Evaluate the Safety, Tolerability, Pharmacokinetics and Pharmacodynamics of ALXN1830 Administered Subcutaneously in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: ALXN1830;Other: PlaceboAlexion PharmaceuticalsNULLWithdrawn18 YearsN/AAll0Phase 2United States
11NCT05218096
(ClinicalTrials.gov)
December 30, 202116/12/2021Study of ALXN2050 in Adult Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Double-Blind, Placebo-Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants With Generalized Myasthenia GravisGeneralized Myasthenia Gravis;Myasthenia GravisDrug: ALXN2050;Drug: PlaceboAlexion PharmaceuticalsNULLRecruiting18 YearsN/AAll70Phase 2United States;Canada;Germany;Italy;Korea, Republic of;Spain;Taiwan
12EUCTR2021-001229-26-IT
(EUCTR)
21/12/202119/10/2021Phase 2 Study of ALXN2050 in Adult Participants with Generalized Myasthenia GravisA Phase 2, Randomized, Double Blind, Placebo Controlled Multicenter Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants withGeneralized Myasthenia Gravis - - Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Trade Name: Menveo
Product Name: Menveo
Product Code: [N/A]
INN or Proposed INN: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP A OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE CRM197 ADSORBED ON ALUMINUM HYDROXIDE
Other descriptive name: N. MENINGITIDIS GROUP C (STRAIN C11) OLIGOSACCHARIDE CONJUGATED TO
INN or Proposed INN: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP W OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (ß197) M8 (CRM197) PROTEIN
INN or Proposed INN: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Other descriptive name: MENINGOCOCCAL GROUP Y OLIGOSACCHARIDES CONJUGATED TO CORYNEBACTERIUM DIPHTHERIAE C7 (Â197) M8 (CRM197) PROTEIN
Trade Name: Velamox
Product Name: Velamox
Product Code: [N/A]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
70Phase 2United States;Taiwan;Canada;Spain;Germany;Italy;Korea, Republic of
13NCT05070858
(ClinicalTrials.gov)
December 14, 202127/9/2021A Study to Examine the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Adult Patients With Symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Symptomatic Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Pozelimab + Cemdisiran;Drug: Cemdisiran;Other: Placebo;Drug: PozelimabRegeneron PharmaceuticalsNULLRecruiting18 YearsN/AAll235Phase 3United States;Australia;Belgium;Canada;Czechia;Denmark;France;Italy;Japan;Korea, Republic of;Poland;Spain;Taiwan;Turkey;United Kingdom
14EUCTR2020-005732-29-PL
(EUCTR)
10/12/202124/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
15NCT05132569
(ClinicalTrials.gov)
December 3, 202112/11/2021Efficacy and Safety of Tolebrutinib (SAR442168) Tablets in Adult Participants With Generalized Myasthenia GravisA Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Tolebrutinib (SAR442168) in Adults With Generalized Myasthenia Gravis (MG)Myasthenia GravisDrug: Tolebrutininb;Drug: PlaceboSanofiNULLTerminated18 Years85 YearsAll6Phase 3United States;Canada;China;Hungary;Italy;Japan;Poland;Spain;United Kingdom
16EUCTR2021-003898-59-HU
(EUCTR)
30/11/202104/12/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - URSA Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: SAR442168
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
Sanofi-Aventis Recherche & DéveloppementNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;Italy;China
17EUCTR2020-005732-29-DE
(EUCTR)
19/11/202123/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
18EUCTR2021-003898-59-IT
(EUCTR)
12/11/202106/10/2021Efficacy and safety of tolebrutinib (SAR442168) tablets in adult participants with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of tolebrutinib (SAR442168) in adults with generalized myasthenia gravis (MG) - . Myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Tolebrutininb
Product Code: [SAR442168]
INN or Proposed INN: Tolebrutinib
Other descriptive name: PRN2246
SANOFI-AVENTIS RECHERCHE E DEVELOPPEMENTNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
192Phase 3United States;Hungary;Canada;Spain;Poland;Russian Federation;Germany;United Kingdom;Japan;China;Italy
19EUCTR2020-005732-29-SE
(EUCTR)
03/11/202124/06/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
20EUCTR2020-004436-21-DE
(EUCTR)
02/11/202116/03/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
21EUCTR2020-005732-29-CZ
(EUCTR)
21/10/202115/07/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
180Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
22NCT04963270
(ClinicalTrials.gov)
October 19, 20217/7/2021A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia GravisA Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Satralizumab;Other: PlaceboHoffmann-La RocheChugai PharmaceuticalRecruiting12 YearsN/AAll240Phase 3United States;Argentina;Australia;Brazil;Canada;China;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Netherlands;Poland;Russian Federation;Spain;Taiwan;Turkey
23NCT04965987
(ClinicalTrials.gov)
October 202110/6/2021Oxaloacetate in Myasthenia GravisA Phase I, Double-Blind, Pilot Study of Oxaloacetate in Myasthenia GravisMyasthenia GravisDrug: Oxaloacetate;Drug: PlaceboUniversity of Kansas Medical CenterTerra Biological LLCNot yet recruiting18 YearsN/AAll12Phase 1United States
24EUCTR2020-004436-21-PL
(EUCTR)
27/09/202128/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
25NCT05039190
(ClinicalTrials.gov)
September 25, 202129/8/2021Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG PatientsA Multicenter, Randomized, Double-blind, Placebo-controlled, Seamless and Group Sequential Phase 2/3 Study to Evaluate the Efficacy and Safety of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: HBM9161 Injection (680mg);Drug: PlaceboHarbour BioMed (Guangzhou) Co. Ltd.NULLCompleted18 Years99 YearsAll132Phase 3China
26EUCTR2020-005732-29-ES
(EUCTR)
03/09/202126/08/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis Myasthenia gravis (MG).
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: Nipocalimab
Product Code: JNJ-80202135
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
Janssen-Cilag International N.V.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
27EUCTR2020-005732-29-IT
(EUCTR)
20/08/202112/10/2021Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis - N/A Myasthenia gravis (MG);Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]Product Name: Nipocalimab
Product Code: [JNJ-80202135]
INN or Proposed INN: Nipocalimab
Other descriptive name: M281
JANSSEN CILAG INTERNATIONAL NVNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
105Phase 3United States;Czechia;Taiwan;Spain;Turkey;Russian Federation;Colombia;United Kingdom;Italy;France;Czech Republic;Hungary;Mexico;Canada;Poland;Belgium;Denmark;Australia;Germany;China;Japan;Sweden;Korea, Republic of
28JPRN-jRCT2021210003
18/08/202121/04/2021Myasthenia Gravis Inebilizumab TrialA Randomized, Double-Blind, Multicenter, Placebo-Controlled Phase 3 Study with Open-Label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults with Myasthenia Gravis - VIB0551.P3.S1 AChR-Ab+ or MuSK-Ab+ generalized Myasthenia Gravis(RCP: Randomized Controlled Period)
Treatment group 1: AChR-Ab positive population (active) - inebilizumab 300 mg administered intravenously (IV) on Days 1, 15, and 183 of the RCP
Treatment group 2: AChR-Ab positive population (placebo) - IV placebo on Days 1, 15, and 183 of the RCP
Treatment group 3: MuSK-Ab positive population (active) - inebilizumab 300 mg IV on Days 1 and 15 of the 26-week RCP
Treatment group 4: MuSK-Ab positive population (placebo) - IV placebo on Days 1 and 15 of the 26-week RCP
Katayama SotaNULLRecruiting>= 18age oldNot applicableBoth16Phase 3USA;Ukraine;China;Argentina;Brazil;Canada;France;Denmark;Germany;Israel;India;Italy;Poland;Spain;Belarus;Russia;Taiwan;Turkey;South Korea;Japan
29EUCTR2020-004436-21-DK
(EUCTR)
11/08/202111/03/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Product Name: Satralizumab
Product Code: Ro 533-3787/F01-06
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Denmark;Australia;Germany;Netherlands;China;Japan;Korea, Republic of
30EUCTR2020-004436-21-NL
(EUCTR)
05/08/202106/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Product Name: Satralizumab
Product Code: Ro 533-3787/F01-06
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
31NCT04951622
(ClinicalTrials.gov)
July 15, 202130/6/2021A Study of Nipocalimab Administered to Adults With Generalized Myasthenia GravisPhase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Nipocalimab Administered to Adults With Generalized Myasthenia GravisMyasthenia GravisDrug: Nipocalimab;Drug: PlaceboJanssen Research & Development, LLCNULLRecruiting18 YearsN/AAll190Phase 3United States;Australia;Belgium;Canada;China;Colombia;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Poland;Spain;Sweden;Taiwan;United Kingdom;Russian Federation;Turkey
32EUCTR2020-004436-21-ES
(EUCTR)
17/06/202102/09/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
Roche Farma S. A. U. que realiza el ensayo en España y que actúa como representante F. Hoffmann-La Roche LtdNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
33EUCTR2020-004436-21-IT
(EUCTR)
21/05/202108/06/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS - - Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: [RO5333787]
INN or Proposed INN: SATRALIZUMAB
F. HOFFMANN - LA ROCHE LTD.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of
34NCT04524273
(ClinicalTrials.gov)
August 30, 202010/8/2020Myasthenia Gravis Inebilizumab TrialA Randomized, Double-blind, Multicenter, Placebo-controlled Phase 3 Study With Open-label Period to Evaluate the Efficacy and Safety of Inebilizumab in Adults With Myasthenia GravisMyasthenia GravisDrug: inebilizumab;Drug: IV PlaceboViela Bio (acquired by Horizon Therapeutics)NULLRecruiting18 YearsN/AAll270Phase 3United States;Argentina;Belarus;Brazil;Canada;China;Denmark;France;Germany;India;Israel;Italy;Japan;Korea, Republic of;Poland;Russian Federation;Spain;Taiwan;Turkey;Ukraine
35EUCTR2019-003383-47-IT
(EUCTR)
12/08/202025/09/2020A Study to Investigate the Safety, Tolerability, and Efficacy of TAK-079 in Participants With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia Gravis - - Generalized Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: TAK-079
Product Code: [TAK-079, TSF-021, TSF79]
INN or Proposed INN: TAK-079
Other descriptive name: TAK-079
Product Name: metilprdnisolone
Product Code: [-]
INN or Proposed INN: METILPREDNISOLONE
Other descriptive name: methylprednisolone
Product Name: difenidramina
Product Code: [NA]
INN or Proposed INN: DIFENIDRAMINA CLORIDRATO
Other descriptive name: diphenhydramine hydrochloride
Product Name: paracetamolo
Product Code: [acetominofene]
INN or Proposed INN: PARACETAMOLO
Other descriptive name: acetaminophen
MILLENNIUM PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
36Phase 2United States;Serbia;Canada;Spain;Poland;Italy
36NCT04346888
(ClinicalTrials.gov)
July 23, 202013/4/2020A Study to Evaluate the Efficacy, Safety and PD and PK of HBM9161 in MG PatientsA Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Pharmacodynamic and Pharmacokinetic of HBM9161 (HL161) Subcutaneous Injection in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: HBM9161 Injection (680mg and 340 mg);Drug: Placebos;Drug: HBM9161 Injection (340 mg)Harbour BioMed (Guangzhou) Co. Ltd.NULLCompleted18 Years99 YearsAll30Phase 2China
37EUCTR2018-003243-39-PT
(EUCTR)
15/06/202006/02/2020Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of
38EUCTR2019-001564-30-ES
(EUCTR)
13/05/202011/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany
39EUCTR2019-001564-30-DE
(EUCTR)
31/03/202001/10/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
156Phase 3France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of
40JPRN-JapicCTI-205207
11/3/202004/03/2020A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis Generalized myasthenia gravisIntervention name : Rozanolixizumab
INN of the intervention : rozanolixizumab
Dosage And administration of the intervention : Rozanolixizumab will be administered by subcutaneous infusion in 2 different dosages
(dose 1 and dose 2) in dosage regimen 1 and 2.
Control intervention name : Placebo
INN of the control intervention : -
Dosage And administration of the control intervention : -
UCB Japan Co., Ltd.NULLcomplete18BOTH18Phase 3Japan, Asia except Japan, North America, Europe
41EUCTR2018-003243-39-GB
(EUCTR)
11/02/202008/10/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;United Kingdom;Switzerland;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
42NCT04159805
(ClinicalTrials.gov)
January 20, 20208/11/2019A Study of TAK-079 in People With Generalized Myasthenia GravisA Phase 2, Randomized, Placebo-Controlled Study to Evaluate Safety, Tolerability, and Efficacy of TAK-079 in Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: TAK-079;Drug: TAK-079 PlaceboTakedaNULLCompleted18 YearsN/AAll36Phase 2United States;Canada;Italy;Poland;Serbia;Spain
43EUCTR2019-001564-30-IT
(EUCTR)
10/01/202007/01/2021A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
Product Code: [na]
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy
44EUCTR2018-003243-39-CZ
(EUCTR)
02/01/202013/09/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitorA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noPortugal;United States;Spain;Turkey;Austria;Russian Federation;Israel;Italy;Switzerland;United Kingdom;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
45EUCTR2019-000968-18-PL
(EUCTR)
19/12/201909/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany
46EUCTR2019-000968-18-DE
(EUCTR)
15/11/201910/07/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
47EUCTR2019-000968-18-GB
(EUCTR)
14/11/201928/06/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients with Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3Russian Federation;Hong Kong;Hungary;United States;United Kingdom;Spain;Canada;Czech Republic;Belgium;Taiwan;Denmark;Poland;Italy;France;Germany
48EUCTR2019-000968-18-CZ
(EUCTR)
11/11/201913/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
49EUCTR2019-001564-30-GB
(EUCTR)
29/10/201901/11/2019A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia GravisA Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: LLT;Classification code 10028415;Term: Myasthenia;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Zilucoplan
INN or Proposed INN: Zilucoplan
Ra Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
130Phase 3France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom
50EUCTR2019-000968-18-BE
(EUCTR)
14/10/201914/08/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
51EUCTR2018-003243-39-AT
(EUCTR)
09/10/201926/04/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Ravulizumab
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLNot RecruitingFemale: yes
Male: yes
160Phase 3United States;Portugal;Spain;Austria;Russian Federation;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Germany;Netherlands;Japan;Korea, Republic of
52EUCTR2019-000968-18-IT
(EUCTR)
25/09/201927/01/2021A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: [UCB7665]
INN or Proposed INN: rozanolixizumab
UCB Biopharma SRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
53EUCTR2019-000968-18-HU
(EUCTR)
25/09/201923/07/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravisA Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany
54EUCTR2018-003243-39-DK
(EUCTR)
20/09/201922/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of
55EUCTR2019-000968-18-DK
(EUCTR)
06/09/201924/06/2019A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia Gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: ROZANOLIXIZUMAB
UCB Biopharma SRLNULLNot RecruitingFemale: yes
Male: yes
240Phase 3United States;Czechia;Hong Kong;Taiwan;Spain;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
56EUCTR2019-000968-18-ES
(EUCTR)
28/08/201912/09/2019A study to test efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis.A Phase 3, randomized, double-blind, placebo-controlled study evaluating efficacy and safety of rozanolixizumab in adult patients with generalized myasthenia gravis. - MycarinGstudy Generalized myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Rozanolixizumab
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
UCB Biopharma SPRLNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
240Phase 3United States;Spain;Russian Federation;Italy;United Kingdom;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Germany
57EUCTR2018-003243-39-DE
(EUCTR)
30/07/201925/03/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Trade Name: Ultomiris 1,100 mg/11 mL
Product Name: ravulizumab
Product Code: ALXN1210
INN or Proposed INN: RAVULIZUMAB
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Germany;Netherlands;Japan;Korea, Republic of;Portugal
58EUCTR2018-003243-39-NL
(EUCTR)
22/07/201901/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
160Phase 3United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Denmark;Netherlands;Germany;Japan;Korea, Republic of
59EUCTR2018-003243-39-IT
(EUCTR)
17/06/201922/01/2021Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis - NA Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Ultomiris
Product Name: Ravulizumab
Product Code: [ALXN1210]
ALEXION PHARMACEUTICALS INCORPORATEDNULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
158Phase 3Portugal;United States;Czechia;Spain;Austria;Israel;Russian Federation;United Kingdom;Switzerland;Italy;France;Czech Republic;Canada;Belgium;Denmark;Netherlands;Germany;Japan;Korea, Republic of
60NCT03971422
(ClinicalTrials.gov)
June 3, 201929/5/2019A Study to Test Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled Study Evaluating Efficacy and Safety of Rozanolixizumab in Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: Rozanolixizumab;Other: PlaceboUCB Biopharma SRLNULLCompleted18 YearsN/AAll200Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Poland;Russian Federation;Serbia;Spain;Taiwan;United Kingdom
61EUCTR2018-003243-39-ES
(EUCTR)
21/05/201927/05/2019Study to evaluate the safety and efficacy of ravulizumab in adult patients with generalized Myasthenia Gravis who have never been treated with a complement inhibitor.A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia Gravis Generalized Myasthenia Gravis
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Ravulizumab
Product Code: ALXN1210
INN or Proposed INN: Fc- and CDR-modified humanised monoclonal antibody against C5
Other descriptive name: Fc- and CDR-modified humanised monoclonal antibody against C5
Alexion Pharmaceuticals IncorporatedNULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
160 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Canada;Spain;Denmark;Austria;Israel;Netherlands;Germany;Japan;Italy;Switzerland;Korea, Republic of
62NCT03863080
(ClinicalTrials.gov)
May 21, 201920/2/2019A Study of RVT-1401 in Myasthenia Gravis (MG) PatientsA Phase 2a, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study With an Open-Label Extension of RVT-1401 in Myasthenia Gravis PatientsMyasthenia GravisDrug: RVT-1401;Drug: PlaceboImmunovant Sciences GmbHNULLCompleted18 YearsN/AAll17Phase 2United States;Canada
63EUCTR2018-002132-25-NL
(EUCTR)
30/04/201926/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Turkey;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Netherlands;Germany;Japan;Sweden
64NCT03772587
(ClinicalTrials.gov)
April 10, 201910/12/2018A Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia GravisA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults With Generalized Myasthenia GravisGeneralized Myasthenia GravisDrug: M281;Other: PlaceboMomenta Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll68Phase 2United States;Belgium;Canada;Germany;Italy;Poland;Spain;United Kingdom
65NCT03914638
(ClinicalTrials.gov)
April 1, 201911/4/2019Beta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisBeta-agonist Efficacy and Tolerability as Adjuvant Therapy in Myasthenia GravisMyasthenia GravisDrug: Salbutamol 4Mg Tablet;Drug: Placebo oral capsuleUniversity of AarhusNULLRecruiting18 YearsN/AAll30Phase 2/Phase 3Denmark
66NCT03920293
(ClinicalTrials.gov)
March 26, 201916/4/2019Safety and Efficacy Study of Ravulizumab in Adults With Generalized Myasthenia GravisA Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Safety and Efficacy of Ravulizumab in Complement-Inhibitor-Naïve Adult Patients With Generalized Myasthenia GravisGeneralized Myasthenia GravisBiological: Ravulizumab;Drug: PlaceboAlexion PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll175Phase 3United States;Austria;Canada;Czechia;Denmark;France;Germany;Israel;Italy;Japan;Korea, Republic of;Netherlands;Portugal;Spain;Switzerland
67EUCTR2018-002247-28-BE
(EUCTR)
18/03/201905/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Poland;Spain;Belgium;Germany;Italy;United Kingdom
68EUCTR2018-002247-28-PL
(EUCTR)
27/02/201931/12/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Spain;Belgium;Poland;Germany;United Kingdom;Italy
69EUCTR2018-002132-25-CZ
(EUCTR)
25/02/201901/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
70EUCTR2018-002132-25-DE
(EUCTR)
22/02/201912/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
71EUCTR2018-002247-28-GB
(EUCTR)
05/02/201930/11/2018To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;Italy;United Kingdom
72EUCTR2018-002247-28-IT
(EUCTR)
04/02/201904/11/2020To evaluate the efficacy, safety and tolerability of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis - VIVACITY Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduction of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: [M281]
INN or Proposed INN: M281
MOMENTA PHARMACEUTICALS, IncNULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;Canada;Spain;Poland;Belgium;Germany;United Kingdom;Italy
73EUCTR2018-002132-25-HU
(EUCTR)
28/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Hungary;Czech Republic;Canada;Belgium;Poland;Denmark;Germany;Netherlands;Japan;Sweden
74EUCTR2018-002132-25-BE
(EUCTR)
21/01/201916/11/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
75EUCTR2018-002132-25-FR
(EUCTR)
15/01/201929/10/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Germany;Netherlands;Japan;Sweden
76EUCTR2018-002247-28-ES
(EUCTR)
14/12/201818/01/2019To evaluate the efficacy of M281 injection for the treatment of patients with Myasthenia gravis, a neuromuscular diseaseA Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics and Pharmacodynamics of M281 Administered to Adults with Generalized Myasthenia Gravis Treatment of MG, with an initial focus on patients with gMG treated with M281 injection and evaluation of the expected reduce of circulating levels of antibodies by blocking IgG recycling, including the pathogenic autoantibodies that cause MG, and to ameliorate manifestations of the disease.
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Product Name: M281 Injection
Product Code: M281
INN or Proposed INN: M281
Other descriptive name: M281
Momenta Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2United States;France;Canada;Poland;Belgium;Spain;Germany;United Kingdom;Italy
77EUCTR2018-002132-25-DK
(EUCTR)
13/12/201828/09/2018An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: ARGX-113
INN or Proposed INN: Efgartigimod
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3United States;Serbia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Belgium;Poland;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
78EUCTR2018-002132-25-IT
(EUCTR)
27/11/201812/02/2021An efficacy and safety study of ARGX-113 in patients with myasthenia gravis who have generalized muscle weakness.A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients with Myasthenia Gravis Having Generalized Muscle Weakness. - NA Myasthenia Gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 21.1;Level: LLT;Classification code 10028423;Term: Myasthenia gravis-like syndrome;System Organ Class: 10029205 - Nervous system disorders
MedDRA version: 20.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: Efgartigimod
Product Code: [ARGX-113]
INN or Proposed INN: Efgartigimod
ARGEN-X BVBANULLNot RecruitingFemale: yes
Male: yes
150Phase 3Serbia;United States;Czechia;Russian Federation;United Kingdom;Italy;France;Czech Republic;Hungary;Canada;Poland;Belgium;Denmark;Georgia;Germany;Netherlands;Japan;Sweden
79NCT03669588
(ClinicalTrials.gov)
September 5, 20186/9/2018An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase 3 Trial to Evaluate the Efficacy, Safety and Tolerability of ARGX-113 in Patients With Myasthenia Gravis Having Generalized Muscle WeaknessGeneralized Myasthenia GravisBiological: ARGX-113;Biological: PlaceboargenxNULLCompleted18 YearsN/AAll167Phase 3United States;Belgium;Canada;Czechia;Denmark;France;Georgia;Germany;Hungary;Italy;Japan;Netherlands;Poland;Russian Federation;Serbia;United Kingdom
80NCT03165435
(ClinicalTrials.gov)
July 201817/5/2017A Study to Evaluate the Efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA Multi-centre, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Active Targeted Immunotherapy CV-MG01 in Patients With Moderate to Severe Myasthenia Gravis.Myasthenia Gravis, GeneralizedBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, AntwerpWithdrawn18 YearsN/AAll0Phase 2/Phase 3Belgium;Netherlands
81NCT03510546
(ClinicalTrials.gov)
April 9, 20186/4/2018Effect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisEffect of Pyridostigmine (Mestinon) on Muscle Strength in Myasthenia GravisMyasthenia GravisDrug: Pyridostigmine;Drug: Placebo oral capsuleUniversity of AarhusAarhus University HospitalRecruiting18 Years90 YearsAll44Phase 4Denmark
82NCT03304054
(ClinicalTrials.gov)
March 7, 201828/9/2017Study to Evaluate Amifampridine Phosphate in Patients With MuSK-MGA Randomized, Placebo-control, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients With MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis PatientsMyasthenia Gravis, GeneralizedDrug: Amifampridine Phosphate;Drug: Placebo Oral TabletCatalyst Pharmaceuticals, Inc.NULLCompleted18 YearsN/AAll70Phase 3United States
83EUCTR2017-004018-25-IT
(EUCTR)
22/02/201819/01/2021Clinical study evaluating the effect of Amifampridine phosphate in patients with MuSK antibody positive myasthenia gravis, and a sample of AchR antibody positive myasthenia gravis patients A Randomized, Placebo-Controlled, Parallel Group Study to Evaluate the Effect of Amifampridine Phosphate in Patients with MuSK Antibody Positive Myasthenia Gravis, and a Sample of AChR Antibody Positive Myasthenia Gravis Patients - MSK-002 MuSK antibody positive myasthenia gravis
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: Amifampridina fosfato
Product Code: [Amifampridina fosfato]
INN or Proposed INN: AMIFAMPRIDINA
CATALYST PHARMACEUTICALS INC.NULLNot RecruitingFemale: yes
Male: yes
70Phase 3United States;Canada;Italy
84EUCTR2017-000323-27-NL
(EUCTR)
03/08/201718/04/2017A study to evaluate the efficacy of CV-MG01 (Myasterix), a therapy for Myasthenia gravisA Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CV-MG01
INN or Proposed INN: Not applicable
Other descriptive name: T-peptide-CRM197 conjugate
INN or Proposed INN: Not applicable
Other descriptive name: B-peptide-CRM197 conjugate
CuraVac Europe SANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
66Phase 2;Phase 3Belgium;Netherlands
85EUCTR2017-000323-27-BE
(EUCTR)
19/06/201713/04/2017A study to evaluate the efficacy of CV-MG01 (Myasterix) in Myasthenia GravisA Multi-center, Randomised, Double-blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy of Subcutaneous Injections of the Myasthenia Gravis Active Targeted Immunotherapy CV-MG01 in Patients with Moderate to Severe Myasthenia Gravis - Myasterix Efficacy Phase 2/3 Study Myasthenia Gravis (MG) is a chronic neuromuscular disorder characterized by weakness and fatigability of skeletal muscles.The underlying defect is a decrease in the number of available acetylcholine receptors (AChRs) at neuromuscular junctions due to an antibody-mediated autoimmune attack.
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: CV-MG01
INN or Proposed INN: Not applicable
Other descriptive name: T-peptide-CRM197 conjugate
INN or Proposed INN: Not applicable
Other descriptive name: B-peptide-CRM197 conjugate
CuraVac Europe SANULLNot RecruitingFemale: yes
Male: yes
66Phase 2;Phase 3Belgium;Netherlands
86EUCTR2016-002698-36-CZ
(EUCTR)
26/05/201703/04/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
87EUCTR2016-002698-36-ES
(EUCTR)
25/05/201731/03/2017Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: UCB7665
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
88EUCTR2016-002698-36-DK
(EUCTR)
19/05/201707/04/2017 Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot Recruiting Female: yes
Male: yes
42 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
89NCT03052751
(ClinicalTrials.gov)
May 15, 201710/2/2017Study to Test the Safety, Tolerability and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia Gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects With Moderate to Severe Myasthenia GravisMyasthenia GravisDrug: UCB7665;Other: PlaceboUCB Biopharma S.P.R.L.NULLCompleted18 YearsN/AAll43Phase 2United States;Belgium;Canada;Czechia;Denmark;Germany;Spain
90EUCTR2016-002698-36-DE
(EUCTR)
09/02/201728/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Belgium;Spain;Denmark;Germany
91EUCTR2016-002698-36-BE
(EUCTR)
30/01/201729/11/2016Study to test the safety, tolerability and efficacy of UCB7665 in subjects with moderate to severe myasthenia gravis.A Multicenter, Randomized, Investigator- and Subject-Blind, Placebo-Controlled, Treatment Sequence Study Evaluating the Safety, Tolerability, and Efficacy of UCB7665 in Subjects with Moderate to Severe Myasthenia Gravis. Moderate to severe myasthenia gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Name: UCB7665
Product Code: UCB7665
INN or Proposed INN: rozanolixizumab
Other descriptive name: UCB7665
UCB Biopharma SPRLNULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Czech Republic;Canada;Spain;Belgium;Denmark;Germany
92NCT02965573
(ClinicalTrials.gov)
December 30, 201620/10/2016A Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessA Randomized, Double-blind, Placebo-Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle WeaknessMyasthenia GravisBiological: ARGX-113;Drug: PlaceboargenxQuintiles, Inc.Completed18 YearsN/AAll24Phase 2United States;Belgium;Canada;Italy;Netherlands;Poland;Spain;Sweden
93EUCTR2016-002938-73-NL
(EUCTR)
08/12/201603/10/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
94EUCTR2016-002938-73-IT
(EUCTR)
01/12/201622/02/2018A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA A Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness. - NA Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
Other descriptive name: ARGX-113
ARGEN-X BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Spain;Poland;Belgium;Netherlands;Italy;Sweden
95EUCTR2016-002938-73-ES
(EUCTR)
08/11/201626/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Belgium;Spain;Netherlands;Italy;Sweden
96EUCTR2016-002938-73-BE
(EUCTR)
31/10/201613/09/2016A Study of the safety and effectiveness of ARGX-113 in Patients with Myasthenia Gravis who have Generalized Muscle WeaknessA Randomized, Double blind, Placebo Controlled Phase II Study to Evaluate the Safety, Efficacy, and Pharmacokinetics of ARGX 113 in Patients with Myasthenia Gravis who have Generalized Muscle Weakness Myasthenia Gravis who have Generalized Muscle Weakness
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Body processes [G] - Immune system processes [G12]
Product Name: ARGX-113
Product Code: ARGX-113
INN or Proposed INN: N/A
Other descriptive name: ARGX-113
Argenx BVBANULLNot RecruitingFemale: yes
Male: yes
24Phase 2United States;Canada;Poland;Spain;Belgium;Netherlands;Italy;Sweden
97NCT02950155
(ClinicalTrials.gov)
October 16, 201628/10/2016A Study Evaluating the Safety and Efficacy of Rituximab in Patients With Myasthenia GravisA Randomized, Double-blind, Placebo-controlled Multicenter Study Evaluating the Safety and Efficacy of Rituximab (Mabthera®) in Patients With New Onset Generalized Myasthenia Gravis (MG)Generalized Myasthenia GravisDrug: Rituximab;Drug: Sodium Chloride solutionFredrik PiehlNULLActive, not recruiting18 YearsN/AAll47Phase 3Sweden
98EUCTR2015-005749-30-SE
(EUCTR)
23/06/201628/04/2016A clinical trial investigating the effect and safety of the drug rituximab in patients with new onset myasthenia gravis, an autoimmune condition affecting muscle strenghtA randomized, doubleblind, placebo-controlled multicenter trial to evaluate the safety and efficacy of rituximab (Mabthera) in subjects with new onset myasthenia gravis; the RINOMAX study - Rinomax New onset myasthenia gravis
MedDRA version: 20.0;Level: SOC;Classification code 10029205;Term: Nervous system disorders;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: Mabthera
INN or Proposed INN: RITUXIMAB
Karolinska InstitutetNULLNot RecruitingFemale: yes
Male: yes
60Phase 3Sweden
99EUCTR2014-003997-18-DE
(EUCTR)
30/05/201627/07/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2Lithuania;Germany;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;France;United States
100NCT02609022
(ClinicalTrials.gov)
March 201613/11/2015Safety, Tolerability and Immunogenic Response of CV-MG01 in Patients With Myasthenia GravisA First-in-human and Proof-of-concept Study to Assess the Safety, Tolerability and Immunogenic Response of CV-MG01, Acetylcholine Receptor Mimetic Peptides, as Potential Therapeutic Vaccine, in Patients With Myasthenia GravisMyasthenia GravisBiological: CV-MG01;Biological: PlaceboCuraVacAepodia;University Hospital, Antwerp;Leiden University Medical CenterCompleted18 Years64 YearsAll24Phase 1/Phase 2Belgium
101EUCTR2013-005099-17-DE
(EUCTR)
18/11/201528/07/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
102EUCTR2013-005099-17-BE
(EUCTR)
06/10/201515/01/2016A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 19.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
103EUCTR2014-003997-18-BE
(EUCTR)
06/10/201518/01/2016A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
104EUCTR2015-003127-62-IT
(EUCTR)
02/10/201517/03/2017A Randomized, Placebo-Controlled Study to Evaluate the Effect of Amifampridine in Patients with MuSK Antibody Positive Myasthenia GravisA Randomized, Placebo-Controlled, Pilot Crossover Study to Evaluate the Effect of Amifampridine Phosphate(3,4-Diaminopyridine Phosphate) in Patients with MuSK Antibody Positive Myasthenia Gravis - MuSK-001 Patients with MuSK Antibody Positive Myasthenia Gravis
MedDRA version: 19.1;Level: LLT;Classification code 10062976;Term: Neuromuscular weakness;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Musculoskeletal Diseases [C05]
Trade Name: FIRDAPSE - 10 MG - COMPRESSE - USO ORALE - BLISTER(ALU/PVC/PVDC) 100 X 1 COMPRESSE
Product Name: AMIFAMPRIDINA
INN or Proposed INN: AMIFAMPRIDINA
FONDAZIONE IRCCS ISTITUTO NEUROLOGICO CARLO BESTANULLNot RecruitingFemale: yes
Male: yes
20Phase 2Italy
105NCT02565576
(ClinicalTrials.gov)
September 29, 201523/6/2015Safety,Tolerability,Pharmacokinetics and Efficacy of CFZ533 in Moderate to Severe Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled, Parallel Group Study to Preliminarily Evaluate the Safety, Tolerability, Pharmacokinetics and Efficacy of CFZ533 in Patients With Moderate to Severe Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: Placebo;Drug: CFZ533Novartis PharmaceuticalsNULLCompleted18 Years85 YearsAll44Phase 2Canada;Denmark;Germany;Russian Federation;Taiwan
106EUCTR2014-003997-18-CZ
(EUCTR)
10/09/201517/06/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
107EUCTR2013-005099-17-CZ
(EUCTR)
10/09/201517/06/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Estonia;Czech Republic;Canada;Belgium;Poland;Lithuania;Germany
108EUCTR2015-000097-35-DK
(EUCTR)
03/09/201516/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 19.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Other descriptive name: CFZ533
Novartis Pharma Services AGNULLNot Recruiting Female: yes
Male: yes
44 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noTaiwan;Canada;Denmark;Russian Federation;Germany
109EUCTR2015-000097-35-DE
(EUCTR)
02/09/201505/06/2015Safety, tolerability and efficacy of CFZ533 in the treatment of moderate to severe myasthenia gravis patientsA multi-center, randomized, double-blind, placebo-controlled, parallel group study to preliminarily evaluate the safety, tolerability, pharmacokinetics and efficacy of CFZ533 in patients with moderate to severe myasthenia gravis - Safety,tolerability,pharmacokinetics and efficacy of CFZ533 in moderate to severe myasthenia gravis Acquired myasthenia gravis (MG) is an autoimmune disease that leads to fluctuating muscle weakness and fatigue. In the most common cases, muscle weakness is caused by circulating antibodies that bind to acetylcholine receptors at the postsynaptic neuromuscular junction, inhibiting the excitatory effects of the neurotransmitter acetylcholine.
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20]
Product Code: CFZ533
Other descriptive name: CFZ533
Novartis Pharma Services AGNULLNot RecruitingFemale: yes
Male: yes
44Phase 2Taiwan;Canada;Denmark;Russian Federation;Germany
110NCT02473952
(ClinicalTrials.gov)
August 201514/6/2015A Study to Evaluate the Efficacy and Safety of IGIV-C in Symptomatic Subjects With Generalized Myasthenia GravisA Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) in Symptomatic Subjects With Generalized Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNULLCompleted18 Years85 YearsAll62Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
111EUCTR2014-003997-18-HU
(EUCTR)
13/07/201526/05/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
112EUCTR2013-005099-17-HU
(EUCTR)
13/07/201526/05/2015A study investigating Immune Globuline (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 18.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Estonia;Czech Republic;Hungary;Canada;Poland;Belgium;Lithuania;Germany
113EUCTR2014-003997-18-LT
(EUCTR)
07/07/201525/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Estonia;Czech Republic;Canada;Poland;Belgium;Lithuania;Germany
114EUCTR2013-005099-17-LT
(EUCTR)
07/07/201525/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
60Phase 2Canada;Czech Republic;Belgium;Hungary;United States;Poland;Lithuania;France;Germany;Estonia
115EUCTR2013-005099-17-EE
(EUCTR)
22/06/201526/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis, dependent on Corticosteroids. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 13 (Week 36). During maintenance doses the investigator will try to slowly reduce the patient's corticosteroid dose.A Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (lGIV -C) as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics LLCNULLNot Recruiting Female: yes
Male: yes
60 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noFrance;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
116EUCTR2014-003997-18-EE
(EUCTR)
22/06/201526/05/2015A study investigating Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C) for the treatment of patients with Myasthenia Gravis. The patients will receive 2g/kg of IP as a loading dose. The loading dosage is followed by maintenance doses of 1 g/kg administered every third week until Visit 8 (Week 21).A Multi-center, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Immune Globulin (Human), 10% Caprylate/ Chromatography Purified (IGIV -C) in Symptomatic Subjects with Generalized Myasthenia Gravis Myasthenia Gravis
MedDRA version: 20.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: GAMUNEX 10%
INN or Proposed INN: Immune Globulin (Human), 10% Caprylate/Chromatography Purified (IGIV-C)
Other descriptive name: HUMAN NORMAL IMMUNOGLOBULIN (IV)
Grifols Therapeutics Inc.NULLNot RecruitingFemale: yes
Male: yes
62Phase 2France;United States;Hungary;Czech Republic;Estonia;Canada;Poland;Belgium;Lithuania;Germany
117NCT02473965
(ClinicalTrials.gov)
June 201514/6/2015Efficacy and Safety of IGIV-C in Corticosteroid Dependent Patients With Generalized Myasthenia GravisA Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of lGIV-C as a Corticosteroid Sparing Agent in Corticosteroid Dependent Patients With Generalized Myasthenia GravisMyasthenia GravisDrug: IGIV-C;Drug: PlaceboGrifols Therapeutics LLCNULLCompleted18 Years85 YearsAll60Phase 2United States;Belgium;Canada;Czechia;Estonia;France;Germany;Hungary;Lithuania;Poland;Czech Republic
118EUCTR2013-003589-15-CZ
(EUCTR)
22/04/201526/02/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden;United Kingdom
119EUCTR2013-003589-15-HU
(EUCTR)
31/03/201520/01/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
Product Name: Soliris
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Spain;Ireland;Russian Federation;Israel;Switzerland;Italy;France;Australia;Denmark;Netherlands;Finland;Turkey;Austria;United Kingdom;Hungary;Czech Republic;Canada;Argentina;Brazil;Belgium;Germany;Norway;Japan;Sweden
120NCT02301624
(ClinicalTrials.gov)
November 12, 201422/11/2014Extension Study of ECU-MG-301 to Evaluate Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia GravisA Phase III, Open-label Extension Trial of ECU-MG-301 to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)Refractory Generalized Myasthenia GravisBiological: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll117Phase 3United States;Argentina;Belgium;Brazil;Canada;Czechia;Denmark;Finland;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom
121EUCTR2013-003589-15-NL
(EUCTR)
09/09/201424/02/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Germany;Netherlands;Japan;Sweden
122EUCTR2013-003589-15-FI
(EUCTR)
04/06/201409/05/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
123EUCTR2013-003589-15-BE
(EUCTR)
28/05/201410/02/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
124EUCTR2013-003589-15-FR
(EUCTR)
20/05/201417/06/2015STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 18.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Switzerland;Italy;France;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
125NCT02110706
(ClinicalTrials.gov)
May 20147/4/2014BeatMG: Phase II Trial of Rituximab In Myasthenia GravisB Cell Targeted Treatment In Myasthenia Gravis (BeatMG): A Phase II Trial of Rituximab In Myasthenia GravisMyasthenia GravisDrug: Rituximab;Drug: PlaceboYale UniversityNational Institute of Neurological Disorders and Stroke (NINDS)Completed21 Years90 YearsAll52Phase 2United States
126EUCTR2013-003589-15-GR
(EUCTR)
29/04/201431/03/2014 STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
127EUCTR2013-003589-15-DK
(EUCTR)
29/04/201404/03/2014STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
128EUCTR2013-003589-15-DE
(EUCTR)
07/04/201420/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Denmark;Australia;Norway;Netherlands;Germany;Japan;Sweden
129EUCTR2013-003589-15-ES
(EUCTR)
24/02/201427/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
130EUCTR2013-003589-15-IT
(EUCTR)
11/02/201417/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 16.1;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;United Kingdom;Italy;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Brazil;Belgium;Denmark;Australia;Netherlands;Norway;Germany;Japan;Sweden
131EUCTR2013-003589-15-SE
(EUCTR)
03/02/201416/12/2013STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTSA RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED,MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OFECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 19.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
92Phase 3United States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;Switzerland;United Kingdom;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
132EUCTR2013-003589-15-GB
(EUCTR)
03/02/201417/12/2013 STUDY OF ECULIZUMAB IN REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG)SUBJECTS A RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED, MULTI-CENTER STUDY TO EVALUATE THE SAFETY AND EFFICACY OF ECULIZUMAB IN SUBJECTS WITH REFRACTORY GENERALIZED MYASTHENIA GRAVIS (GMG) Generalized Myasthenia Gravis
MedDRA version: 17.0;Level: HLT;Classification code 10071942;Term: Myasthenia gravis and related conditions;System Organ Class: 100000004859 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: SOLIRIS
INN or Proposed INN: ECULIZUMAB
Alexion Pharmaceuticals, Inc.NULLNot Recruiting Female: yes
Male: yes
92 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): noUnited States;Greece;Finland;Spain;Ireland;Turkey;Austria;Italy;United Kingdom;Switzerland;France;Czech Republic;Hungary;Canada;Argentina;Belgium;Brazil;Australia;Denmark;Norway;Netherlands;Germany;Japan;Sweden
133NCT01997229
(ClinicalTrials.gov)
December 201318/11/2013Safety and Efficacy of Eculizumab in Refractory Generalized Myasthenia Gravis (REGAIN Study)A Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Evaluate the Safety and Efficacy of Eculizumab in Subjects With Refractory Generalized Myasthenia Gravis (gMG)Refractory Generalized Myasthenia GravisBiological: Eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLCompleted18 YearsN/AAll125Phase 3United States;Argentina;Australia;Belgium;Brazil;Canada;Czechia;Denmark;Finland;France;Germany;Greece;Hungary;Italy;Japan;Korea, Republic of;Netherlands;Spain;Sweden;Turkey;United Kingdom;Czech Republic
134NCT01480596
(ClinicalTrials.gov)
April 201327/10/2011The Evaluation of Belimumab in Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects With Generalized Myasthenia Gravis (MG)Myasthaenia GravisBiological: Belimumab;Other: PlaceboGlaxoSmithKlineNULLCompleted18 YearsN/AAll40Phase 2United States;Canada;Germany;Italy
135JPRN-UMIN000007679
2012/04/0109/04/2012Randomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patientsRandomized comparative study on efficacy and safety of tacrolimus, prednisolone or placebo in ocular myasthenia gravis patients - Efficacy and safety of tacrolimus in ocular myasthenia gravis Myasthenia gravisAdministration of tacrolimus 3 mg/day
Administration of prednisolone 5 mg/day
anticholinesterases
Department of Neurology, Chiba University Graduate School of MedicineNULLRecruiting20years-oldNot applicableMale and Female60Not selectedJapan
136EUCTR2011-002068-26-IT
(EUCTR)
28/12/201115/12/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG) - Evaluate the Use of Belimumab in Myasthenia Gravis (MG) Subjects with Generalized Myasthenia Gravis (MG)
MedDRA version: 14.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BENLYSTA® (belimumab)
INN or Proposed INN: BELIMUMAB
GLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.NULLNot RecruitingFemale: yes
Male: yes
42United States;Canada;Germany;Italy
137NCT00995722
(ClinicalTrials.gov)
December 201114/10/2009Efficacy of Prednisone In the Treatment of Ocular MyastheniaEfficacy of Prednisone In the Treatment of Ocular Myasthenia: The EPITOME' StudyOcular Myasthenia GravisDrug: Prednisone;Drug: PlaceboMichael BenatarUniversity of Miami;University of RochesterTerminated18 YearsN/AAll11Phase 3United States;Canada
138EUCTR2011-002068-26-DE
(EUCTR)
24/11/201105/10/2011A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG)A Randomized, Placebo-Controlled, Double-Blind Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamics of Belimumab in Subjects with Generalized Myasthenia Gravis (MG). Myasthenia Gravis
MedDRA version: 17.0;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Trade Name: BENLYSTA® (belimumab)
Product Name: Benlysta (belimumab)
Product Code: GSK1550188
INN or Proposed INN: belimumab
GlaxoSmithKline Research & Development LimitedNULLNot RecruitingFemale: yes
Male: yes
42United States;Canada;Germany;Italy
139NCT01325571
(ClinicalTrials.gov)
March 201116/3/2011A Study to Compare the Efficacy and Safety of Tacrolimus Capsules in Patient With Myasthenia GravisA Randomized, Double-blinded, Placebo-controlled, and Multi-centered Clinical Trial Evaluating the Efficacy and Safety of Tacrolimus Capsule in Myasthenia Gravis That Was Insufficiently Treated by Glucocorticoid TherapyMyasthenia GravisDrug: Tacrolimus capsule;Drug: PlaceboAstellas Pharma IncAstellas Pharma China, Inc.Completed18 Years70 YearsBoth83Phase 3China
140NCT01268280
(ClinicalTrials.gov)
December 201028/12/2010Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia GravisA Phase II, Double-Blind, Randomized, Three-Way Crossover, Placebo-Controlled, Pharmacodynamic Study of CK-2017357 in Patients With Generalized Myasthenia Gravis on Standard TherapyMyasthenia GravisDrug: Placebo;Drug: 250 mg CK-2017357;Drug: 500 mg CK-2017357CytokineticsNational Institute of Neurological Disorders and Stroke (NINDS)Terminated18 Years80 YearsAll32Phase 2United States
141EUCTR2009-014669-13-GB
(EUCTR)
29/12/200923/10/2009A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001A Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients with Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment with Immunosuppressants. - C08-001 Generalized Myasthenia Gravis (gMG)
MedDRA version: 12.0;Level: LLT;Classification code 10028417;Term: Myasthenia gravis
Trade Name: SOLIRIS
Product Name: SOLIRIS
INN or Proposed INN: eculizumab
Other descriptive name: Anti-C5 antibody
Alexion Pharmaceuticals Inc.NULLNot RecruitingFemale: yes
Male: yes
24United Kingdom
142NCT00814138
(ClinicalTrials.gov)
April 200923/12/2008Efficacy of Methotrexate in Myasthenia GravisPhase II Trial of Methotrexate in Myasthenia GravisMyasthenia GravisDrug: Methotrexate;Other: PlaceboUniversity of Kansas Medical CenterNULLCompleted18 YearsN/AAll50Phase 2United States;Canada
143NCT00727194
(ClinicalTrials.gov)
October 200830/7/2008Safety and Efficacy Study of Eculizumab in Patients With Refractory Generalized Myasthenia GravisA Randomized, Double-Blind, Placebo-Controlled, Cross-Over, Multi-Center Study of Eculizumab in Patients With Generalized Myasthenia Gravis (gMG) Who Have Moderate to Severe Muscle Weakness Despite Treatment With ImmunosuppressantsMyasthenia GravisDrug: eculizumab;Drug: PlaceboAlexion PharmaceuticalsNULLTerminated18 Years80 YearsAll14Phase 2United States;Canada;United Kingdom
144EUCTR2007-002817-37-IT
(EUCTR)
29/07/200830/06/2008A PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - NDA PHASE II, PLACEBO CONTROLLED, DOSE FINDING PILOT STUDY OF PIXANTRONE EFFICACY ADMINISTERED INTRAVENOUSLY IN PATIENTS AFFECTED WITH MYASTHENIA GRAVIS - ND Patients affected with MG showing clinically meaningful improvement after therapeutic plasmapheresis.
MedDRA version: 9.1;Level: LLT;Classification code 10028417;Term: Myasthenia gravis
Product Name: PIXANTRONE
Product Code: BBR 2778
INN or Proposed INN: pixantrone
ISTITUTO NEUROLOGICO CARLO BESTANULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
Phase 2Italy
145EUCTR2006-004374-27-DE
(EUCTR)
12/10/200607/09/2006Prospective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIentProspective, randomized, doubleblind, placebo-controlled trial on changes in acetylcholine receptor antibody titres in autoimmune myasthenia gravis after influenza vaccination (ProPATIent) - ProPATIent Generalized Myasthenia gravis with positive antibodies against Acetylcholine-receptors (ICD10GM2006 G70.0)Trade Name: Mutagrip
Product Name: Mutagrip
Philipps-UniversityNULLNot RecruitingFemale: yes
Male: yes
Germany
146NCT00309088
(ClinicalTrials.gov)
April 200629/3/2006FK506 Phase 3 Study: a Study for Steroid Non-resistant Myasthenia Gravis (MG) PatientsFK506 Phase 3 Study: a Double Blind Placebo Controlled Study for Steroid Non-Resistant Myasthenia Gravis PatientsMyasthenia GravisDrug: tacrolimus;Drug: placeboAstellas Pharma IncNULLCompleted16 Years64 YearsBoth80Phase 3Japan
147EUCTR2005-000343-28-IT
(EUCTR)
29/03/200615/03/2006An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - NDAn optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil MMF to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis - ND Myasthenia Gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: cellcept
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136United Kingdom;Germany;Spain;Italy
148EUCTR2005-000343-28-DE
(EUCTR)
19/12/200510/05/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 8.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis
Trade Name: Cellcept 500 mg tablets
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceuticals CorporationNULLNot RecruitingFemale: yes
Male: yes
136Spain;Germany;Italy;United Kingdom
149EUCTR2004-000596-34-HU
(EUCTR)
30/09/200508/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche Ltd as part of the Aspreva Rare Disease ProgramNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
150EUCTR2005-000343-28-GB
(EUCTR)
05/09/200528/06/2005An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis)An optional continuation of double-blind treatment for subjects who have achieved good symptom control with stable prednisone dosing and who have completed Protocol WX17798 (A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis) Myasthenia Gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Product Name: CellCept 500 mg tablets
INN or Proposed INN: mycophenolate mofetil
Aspreva Pharmaceutical CorporationNULLNot RecruitingFemale: yes
Male: yes
136Germany;United Kingdom;Spain;Italy
151EUCTR2004-000596-34-ES
(EUCTR)
01/09/200505/07/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis.A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteoids in subjects with myasthenia gravis. Myasthenia gravis
MedDRA version: 7;Level: PT;Classification code 10028417
Trade Name: CellCept®500 mg tablets
Product Name: CellCept 500 mg film-coated tablets
INN or Proposed INN: mycophenolate mofetil
F. Hoffmann-La Roche LtdNULLNot RecruitingFemale: yes
Male: yes
136Phase 3Hungary;Czech Republic;Spain;Italy
152EUCTR2004-000596-34-IT
(EUCTR)
01/06/200520/06/2005A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG)A prospective, randomized, double-blind, placebo-controlled, parallel group, multicenter, 36-week trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptom control with reduced corticosteroids in subjects with myasthenia gravis (MG) Myastenia gravis
MedDRA version: 6.1;Level: PT;Classification code 10028417
Trade Name: CELLCEPT
INN or Proposed INN: Mycophenolic acid
ASPREVA PHARMACEUTICALS CORPORATIONNULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
153EUCTR2004-000596-34-CZ
(EUCTR)
19/05/200506/05/2005A prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravisA prospective, randomized, double-blind, placebo controlled, parallel group, multicenter, 36-weeks trial to assess the efficacy and safety of adjunct mycophenolate mofetil (MMF) to maintain or improve symptoms control with reduced corticosteroids in subjects with mysthenia gravis Myasthenia gravis
MedDRA version: 7.1;Level: LLT;Classification code 10028417
Trade Name: CellCept 500 mg
Product Name: CellCept
F.Hoffmann-La Roche Ltd.NULLNot RecruitingFemale: yes
Male: yes
136Hungary;Czech Republic;Spain;Italy
154NCT00683969
(ClinicalTrials.gov)
August 200419/5/2008A Study to Assess the Effect of CellCept (Mycophenolate Mofetil) and Reduced Corticosteroids in Controlling Symptoms of Myasthenia GravisA Prospective, Randomized, Double-Blind, Placebo-Controlled, Parallel Group, Multicenter, 36-Week Trial to Assess the Efficacy and Safety of Adjunct Mycophenolate Mofetil (MMF) to Maintain or Improve Symptom Control With Reduced Corticosteroid in Subjects With Myasthenia GravisMyasthenia Gravis, GeneralizedDrug: mycophenolate mofetil (CellCept);Drug: placeboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Canada;Former Serbia and Montenegro;France;Germany;India;Israel;Italy;Mexico;Netherlands;Russian Federation;Spain;Ukraine;United Kingdom
155NCT00408213
(ClinicalTrials.gov)
June 20045/12/2006A Continuation Study to Assess the Effect of CellCept in Patients With Myasthenia Gravis.A Randomized, Double-Blind Study to Evaluate the Safety of Continued Treatment With CellCept in Patients With Well-Controlled Myasthenia Gravis Receiving a Stable Dose of PrednisoneMyasthenia Gravis GeneralisedDrug: mycophenolate mofetil [CellCept];Drug: PlaceboHoffmann-La RocheAspreva PharmaceuticalsCompleted18 Years80 YearsBoth136Phase 3United States;Former Serbia and Montenegro;France;Germany;Italy;Ukraine;United Kingdom;Israel;Spain;Canada;Czech Republic;Mexico;Netherlands
156NCT00306033
(ClinicalTrials.gov)
March 200421/3/2006Intravenous Immune Globulin Treatment Compared to Placebo in Patients With Myasthenia GravisIVIG Treatment Compared to Placebo in Patients With Myasthenia Gravis: A Randomized Clinical TrialMyasthenia GravisDrug: Intravenous ImmuneGlobulinUniversity Health Network, TorontoNULLCompleted18 YearsN/ABoth50Phase 3Canada
157EUCTR2020-004436-21-FR
(EUCTR)
12/04/2021A Study to Evaluate Efficacy, Safety, Pharmacokinetics, and Pharmacodynamics of Satralizumab in Patients with Generalized Myasthenia GravisA PHASE III, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE EFFICACY, SAFETY, PHARMACOKINETICS, AND PHARMACODYNAMICS OF SATRALIZUMAB IN PATIENTS WITH GENERALIZED MYASTHENIA GRAVIS Generalized Myasthenia Gravis (gMG)
MedDRA version: 21.1;Level: PT;Classification code 10028417;Term: Myasthenia gravis;System Organ Class: 10029205 - Nervous system disorders;Therapeutic area: Diseases [C] - Nervous System Diseases [C10]
Product Name: Satralizumab
Product Code: RO5333787
INN or Proposed INN: SATRALIZUMAB
F. Hoffmann-La Roche LtdNULLNAFemale: yes
Male: yes
240Phase 3United States;Czechia;Spain;Turkey;Russian Federation;Italy;France;Canada;Argentina;Poland;Brazil;Australia;Denmark;Netherlands;Germany;China;Japan;Korea, Republic of