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 | EUCTR2019-001565-33-PL (EUCTR) | 07/07/2021 | 19/04/2021 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | 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. (now part of UCB) | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 2 | EUCTR2019-001565-33-ES (EUCTR) | 13/05/2020 | 14/01/2020 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | United States;France;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy | ||
| 3 | EUCTR2019-001564-30-ES (EUCTR) | 13/05/2020 | 11/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | United Kingdom;Japan;Italy;United States;France;Canada;Spain;Norway;Germany | ||
| 4 | EUCTR2019-001564-30-DE (EUCTR) | 31/03/2020 | 01/10/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A 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. | NULL | Not Recruiting | Female: yes Male: yes | 156 | Phase 3 | France;United States;Canada;Spain;Poland;Norway;Germany;United Kingdom;Italy;Japan;Korea, Republic of | ||
| 5 | EUCTR2019-001564-30-IT (EUCTR) | 10/01/2020 | 07/01/2021 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy | ||
| 6 | EUCTR2019-001565-33-IT (EUCTR) | 10/01/2020 | 07/01/2021 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;United Kingdom;Japan;Italy | ||
| 7 | NCT04225871 (ClinicalTrials.gov) | December 23, 2019 | 2/10/2019 | Open-Label Extension of Zilucoplan in Subjects With Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: zilucoplan (RA101495) | Ra Pharmaceuticals | NULL | Active, not recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom |
| 8 | EUCTR2019-001565-33-GB (EUCTR) | 30/10/2019 | 01/11/2019 | Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis | A Phase 3, Multicenter, Open-Label Extension Study of Zilucoplan in Subjects with Generalized Myasthenia Gravis - RAISE-XT | 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 200 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom | ||
| 9 | EUCTR2019-001564-30-GB (EUCTR) | 29/10/2019 | 01/11/2019 | A Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Patients with Generalized Myasthenia Gravis | A 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. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 130 | Phase 3 | France;United States;Canada;Spain;Norway;Germany;Japan;Italy;United Kingdom | ||
| 10 | NCT04115293 (ClinicalTrials.gov) | September 17, 2019 | 2/10/2019 | Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis | A Phase 3, Multicenter, Randomized, Double Blind, Placebo-Controlled Study to Confirm the Safety, Tolerability, and Efficacy of Zilucoplan in Subjects With Generalized Myasthenia Gravis | Myasthenia Gravis, Generalized | Drug: zilucoplan (RA101495);Drug: Placebo | Ra Pharmaceuticals | NULL | Completed | 18 Years | 74 Years | All | 174 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom |
| 11 | NCT03315130 (ClinicalTrials.gov) | October 11, 2017 | 16/10/2017 | Safety and Efficacy Study of RA101495 in Subjects With Generalized Myasthenia Gravis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Safety, Tolerability, and Preliminary Efficacy of RA101495 in Subjects With Generalized Myasthenia Gravis | Generalized Myasthenia Gravis | Drug: zilucoplan (RA101495);Drug: Placebo | Ra Pharmaceuticals | NULL | Completed | 18 Years | 85 Years | All | 44 | Phase 2 | United States;Canada |