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

  
12 trials found
No.TrialIDDate_
enrollment
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
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agemax
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PhaseCountries
1JPRN-jRCT2031220102
28/10/202231/05/2022A Study of Nipocalimab in Children Aged 2 to less than 18 Years with Generalized Myasthenia GravisAn Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years with Generalized Myasthenia Gravis Myasthenia GravisNipocalimab will be administered as an IV infusion.
Participants aged 2 to less than [<] 18 years of age will receive nipocalimab once every two weeks for 24 weeks. After Week 24, all participants will have the option to enroll in long term extension (LTE).
Nakano MasayoshiNULLPending>= 2age old<= 17age oldBoth12Phase 2Canada;Netherlands;nitedStates of America;Japan
2NCT05265273
(ClinicalTrials.gov)
July 20, 202222/2/2022A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisAn Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia GravisMyasthenia GravisDrug: NipocalimabJanssen Research & Development, LLCNULLRecruiting2 Years17 YearsAll12Phase 2/Phase 3United States;Canada;Japan;Netherlands;Poland
3JPRN-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
4EUCTR2020-005732-29-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
5EUCTR2020-005732-29-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
6EUCTR2020-005732-29-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
7EUCTR2020-005732-29-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
8EUCTR2020-005732-29-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
9EUCTR2020-005732-29-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
10EUCTR2020-005732-29-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
11NCT04951622
(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
12EUCTR2021-002479-20-NL
(EUCTR)
28/04/2022PK, PD, Safety and Activity of Nipocalimab in Children with Generalized Myasthenia GravisAn Open-Label Uncontrolled Multicenter Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Activity of Nipocalimab in Children Aged 2 to less than 18 years 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 Invernational N.V.NULLNAFemale: yes
Male: yes
12Phase 2;Phase 3France;United States;Canada;Belgium;Germany;Netherlands;United Kingdom;Italy;Japan