11. 重症筋無力症 Myasthenia gravis Clinical trials / Disease details
臨床試験数 : 315 / 薬物数 : 232 - (DrugBank : 77) / 標的遺伝子数 : 46 - 標的パスウェイ数 : 126
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | NCT05265273 (ClinicalTrials.gov) | March 31, 2022 | 22/2/2022 | A Study of Nipocalimab in Children Aged 2 to Less Than 18 Years With Generalized Myasthenia Gravis | An 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 | Drug: Nipocalimab | Janssen Research & Development, LLC | NULL | Not yet recruiting | 2 Years | 17 Years | All | 12 | Phase 2/Phase 3 | United States;Canada;Japan;Netherlands |
| 2 | JPRN-jRCT2021210027 | 20/01/2022 | 13/08/2021 | A Study of Nipocalimab Administered to Adults with Generalized Myasthenia Gravis | Phase 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 | Nipocalimab (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 Masayoshi | NULL | Pending | >= 18age old | Not applicable | Both | 180 | Phase 3 | Belgium;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 |
| 3 | EUCTR2020-005732-29-DK (EUCTR) | 13/01/2022 | 25/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United 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 | ||
| 4 | EUCTR2020-005732-29-DE (EUCTR) | 19/11/2021 | 23/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United 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 | ||
| 5 | EUCTR2020-005732-29-SE (EUCTR) | 03/11/2021 | 24/06/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United 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 | ||
| 6 | EUCTR2020-005732-29-CZ (EUCTR) | 21/10/2021 | 15/07/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 180 | Phase 3 | United 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 | ||
| 7 | EUCTR2020-005732-29-ES (EUCTR) | 03/09/2021 | 26/08/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United 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 | ||
| 8 | EUCTR2020-005732-29-IT (EUCTR) | 20/08/2021 | 12/10/2021 | Efficacy and Safety Study of Nipocalimab IV Infusions for Adults With Generalized Myasthenia Gravis | Phase 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 NV | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 105 | Phase 3 | United 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 | ||
| 9 | NCT04951622 (ClinicalTrials.gov) | July 15, 2021 | 30/6/2021 | A Study of Nipocalimab Administered to Adults With Generalized Myasthenia Gravis | Phase 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 | Drug: Nipocalimab;Drug: Placebo | Janssen Research & Development, LLC | NULL | Recruiting | 18 Years | N/A | All | 180 | Phase 3 | United States;Australia;Belgium;Canada;China;Colombia;Czechia;Denmark;France;Germany;Italy;Japan;Korea, Republic of;Mexico;Poland;Russian Federation;Spain;Sweden;Taiwan;Turkey;United Kingdom |