REGN3918 ( DrugBank: - )


2 diseases
IDDisease name (Link within this page)Number of trials
11Myasthenia gravis5
62Paroxysmal nocturnal hemoglobinuria13

11. Myasthenia gravis


Clinical trials : 315 Drugs : 232 - (DrugBank : 77) / Drug target genes : 46 - Drug target pathways : 126
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-003272-41-DE
(EUCTR)
04/03/202204/01/2022A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
2EUCTR2020-003272-41-ES
(EUCTR)
03/02/202228/09/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
3EUCTR2020-003272-41-IT
(EUCTR)
13/12/202119/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic Generalized Myasthenia Gravis - Study of Pozelimab and Cemdisiran combination therapy in patients with 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] - Nervous System Diseases [C10]
Product Name: Cemdisiran
Product Code: [ALN-CC5]
INN or Proposed INN: Cemdisiran
Product Name: Pozelimab
Product Code: [REGN3918]
INN or Proposed INN: Pozelimab
Trade Name: Bexsero
Product Name: Bexsero
Product Code: [NA]
INN or Proposed INN: Outer membrane vesicles (OMV) from Neisseria meningitidis group B strain NZ98/254measured as amount of total protein containing the PorA P1.4
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B FHBP FUSION PROTEIN PRODUCED IN E.COLI CELLS BY RECOMBINANT DNA TECHNOLOGY ADSORBED ON ALUMINIUM HYDROXIDE
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NHBA FUSION PROTEIN
INN or Proposed INN: RECOMBINANT NEISSERIA MENINGITIDIS GROUP B NADA PROTEIN
Other descriptive name: RECOMBINANT NEISSERIA
REGENERON PHARMACEUTICALS, INC.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Belgium;Poland;Australia;Denmark;Germany;Korea, Republic of
4EUCTR2020-003272-41-PL
(EUCTR)
01/12/202121/10/2021A study to examine the efficacy and safety of pozelimab and cemdisiran combination therapy in patients with symptomatic Generalized Myasthenia GravisEfficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients with Symptomatic 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] - Nervous System Diseases [C10]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
210Phase 3United States;Czechia;Taiwan;Spain;Ukraine;Russian Federation;United Kingdom;Italy;France;Canada;Poland;Belgium;Australia;Denmark;Germany;Korea, Republic of
5NCT05070858
(ClinicalTrials.gov)
September 30, 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 (REGN3918) + Cemdisiran;Drug: Cemdisiran;Other: PlaceboRegeneron PharmaceuticalsNULLNot yet recruiting18 YearsN/AAll210Phase 3NULL

62. Paroxysmal nocturnal hemoglobinuria


Clinical trials : 271 Drugs : 163 - (DrugBank : 49) / Drug target genes : 22 - Drug target pathways : 106
No.TrialIDDate_
enrollment
Date_
registration
Public_titleScientific_titleConditionInterventionPrimary_
sponsor
Secondary_
sponsor
Recruitment_
Status
Inclusion_
agemin
Inclusion_
agemax
Inclusion_
gender
Target_
size
PhaseCountries
1EUCTR2020-005005-17-HU
(EUCTR)
07/05/202105/03/2021Pozelimab and Cemdisiran Combination Treatment in Adult Participants with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab MonotherapyA Randomized, Open-label, Two-arm Study to Evaluate the Safety, Efficacy, and Pharmacodynamic Effects of Pozelimab and Cemdisiran Combination Treatment in Patients with Paroxysmal Nocturnal Hemoglobinuria Who Have Received Pozelimab Monotherapy Paroxysmal Nocturnal Hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: Pozelimab
Product Code: REGN3918
INN or Proposed INN: Pozelimab
Product Name: Cemdisiran
Product Code: ALN-CC5
INN or Proposed INN: Cemdisiran
Other descriptive name: CEMDISIRAN
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
24Phase 2Taiwan;Hong Kong;Hungary;Malaysia;United Kingdom;Korea, Republic of
2EUCTR2018-002734-20-CZ
(EUCTR)
07/08/202015/03/2019A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor TherapyAn Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
3EUCTR2019-000130-20-GB
(EUCTR)
23/04/202019/11/2019REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
147Phase 3Netherlands;Germany;South Africa;Romania;Singapore;Poland;Malaysia;Canada;Hungary;Italy;United Kingdom;Korea, Democratic People's Republic of;Hong Kong;Taiwan;United States
4EUCTR2019-000130-20-NL
(EUCTR)
01/04/202016/10/2019A trial with REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
147Phase 3United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Germany;Netherlands;South Africa;Romania;Singapore;Poland;Malaysia;Canada;Hungary
5EUCTR2019-000130-20-CZ
(EUCTR)
12/02/202014/11/2019REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
147Phase 3United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
6EUCTR2019-000130-20-HU
(EUCTR)
27/01/202025/11/2019REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
147Phase 3United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
7EUCTR2019-000130-20-IT
(EUCTR)
12/12/201924/05/2021REGN3918 in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) to evaluate its long term safety, efficacy and tolerability.An open-label extension study to evaluate the long-term safety, tolerability, and efficacy of REGN3918 in patients with paroxysmal nocturnal hemoglobinuria - R3918-PNH-1868 Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: [REGN3918]
INN or Proposed INN: REGN3918
REGENERON PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
147Phase 3United States;Hong Kong;Taiwan;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands;Korea, Republic of
8NCT04162470
(ClinicalTrials.gov)
December 3, 201911/11/2019REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate Its Long Term Safety, Efficacy and Tolerability.An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of REGN3918 in Patients With Paroxysmal Nocturnal HemoglobinuriaParoxysmal Nocturnal HemoglobinuriaDrug: REGN3918Regeneron PharmaceuticalsNULLActive, not recruiting18 YearsN/AAll24Phase 3Hong Kong;Hungary;Korea, Republic of;Malaysia;Taiwan;United Kingdom
9EUCTR2018-002734-20-NL
(EUCTR)
29/07/201902/04/2019A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor TherapyAn Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Netherlands;Germany
10EUCTR2018-002734-20-GB
(EUCTR)
24/07/201922/03/2019A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor TherapyAn Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
42Phase 2United States;Taiwan;Hong Kong;Korea, Democratic People's Republic of;United Kingdom;Italy;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
11NCT03946748
(ClinicalTrials.gov)
May 16, 20198/5/2019Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH)An Open-Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor-Naive or Have Not Recently Received Complement Inhibitor TherapyParoxysmal Nocturnal Hemoglobinuria (PNH)Drug: REGN3918Regeneron PharmaceuticalsNULLCompleted18 YearsN/AAll24Phase 2Hong Kong;Hungary;Korea, Republic of;Malaysia;United Kingdom
12EUCTR2018-002734-20-IT
(EUCTR)
16/05/201925/05/2021A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor TherapyAn Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy - - Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: [REGN3918]
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
REGENERON PHARMACEUTICALS, INC.NULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands
13EUCTR2018-002734-20-HU
(EUCTR)
10/05/201925/03/2019A trial with REGN3918 in patients Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not been treated previously with a Complement Inhibitor or Have Not Recently Received Complement Inhibitor TherapyAn Open Label, Single Arm Study to Evaluate the Efficacy and Safety of REGN3918 in Patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Are Complement Inhibitor Naive or Have Not Recently Received Complement Inhibitor Therapy Paroxysmal nocturnal hemoglobinuria
MedDRA version: 21.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15]
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Product Name: REGN3918
Product Code: REGN3918
INN or Proposed INN: REGN3918
Other descriptive name: REGN3918
Regeneron Pharmaceuticals, Inc.NULLNot RecruitingFemale: yes
Male: yes
42Phase 2United States;Hong Kong;Taiwan;Korea, Democratic People's Republic of;United Kingdom;Italy;Czech Republic;Hungary;Canada;Malaysia;Poland;Singapore;Romania;South Africa;Germany;Netherlands