Zilucoplan ( DrugBank: Zilucoplan )
3 diseases
| 告示番号 | 疾患名（ページ内リンク） | 臨床試験数 |
|---|---|---|
| 2 | 筋萎縮性側索硬化症 | 1 |
| 11 | 重症筋無力症 | 10 |
| 62 | 発作性夜間ヘモグロビン尿症 | 3 |
2. 筋萎縮性側索硬化症
臨床試験数 : 645 / 薬物数 : 589 - (DrugBank : 163) / 標的遺伝子数 : 150 - 標的パスウェイ数 : 225
| 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 | NCT04297683 (ClinicalTrials.gov) | July 14, 2020 | 3/3/2020 | HEALEY ALS Platform Trial - Master Protocol | HEALEY ALS Platform Trial | Amyotrophic Lateral Sclerosis | Drug: Zilucoplan;Drug: Verdiperstat;Drug: CNM-Au8;Drug: Pridopidine;Drug: SLS-005 Trehalose | Merit E. Cudkowicz, MD | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 800 | Phase 2/Phase 3 | United States |
11. 重症筋無力症
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
| 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 | NCT05514873 (ClinicalTrials.gov) | October 31, 2022 | 22/8/2022 | An Open-label Study to Evaluate the Safety, Tolerability, and Efficacy of Subcutaneous Zilucoplan in Participants With Generalized Myasthenia Gravis Who Were Previously Receiving Intravenous Complement Component 5 Inhibitors | A Phase 3b, Multicenter, Open-Label, Single-Arm Study to Evaluate the Safety, Tolerability, and Efficacy of Zilucoplan in Participants With Generalized Myasthenia Gravis Switching From Intravenous Complement Component 5 Inhibitors to Subcutaneous Zilucoplan | Generalized Myasthenia Gravis | Drug: zilucoplan (RA101495) | UCB Biopharma SRL | NULL | Recruiting | 18 Years | 85 Years | All | 20 | Phase 3 | United States |
| 2 | 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 | ||
| 3 | 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 | ||
| 4 | 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 | ||
| 5 | 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 | ||
| 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 | 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 | ||
| 8 | 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, Inc. | NULL | Active, not recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Poland;Spain;United Kingdom |
| 9 | 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 | ||
| 10 | 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 |
62. 発作性夜間ヘモグロビン尿症
臨床試験数 : 292 / 薬物数 : 151 - (DrugBank : 49) / 標的遺伝子数 : 22 - 標的パスウェイ数 : 108
| 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 | EUCTR2018-003956-19-FI (EUCTR) | 13/02/2019 | 28/01/2019 | Study of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria (PNH) | Phase 3, Multicenter, Open-Label, Single-Arm Study to Confirm the Safety and Efficacy of Zilucoplan in Treatment-Naïve Subjects with Paroxysmal Nocturnal Hemoglobinuria - Phase 3 Study in Treatment-Naive Paroxysmal Nocturnal Hemoglobinuria Patients | Paroxysmal Nocturnal Hemoglobinuria (PNH) MedDRA version: 20.1;Level: LLT;Classification code 10055629;Term: Paroxysmal nocturnal hemoglobinuria;System Organ Class: 100000004857;Therapeutic area: Diseases [C] - Blood and lymphatic diseases [C15] | Product Name: Zilucoplan Product Code: RA101495 INN or Proposed INN: ZILUCOPLAN Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a polyethyleneglycol palmitoylated linker | Ra Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 40 | Phase 3 | United States;Hong Kong;Taiwan;Finland;Spain;Turkey;Russian Federation;Italy;United Kingdom;Czech Republic;Mexico;Canada;Argentina;Malaysia;Belgium;Brazil;Australia;Georgia;Germany;New Zealand;Korea, Republic of | ||
| 2 | NCT03225287 (ClinicalTrials.gov) | July 17, 2017 | 17/7/2017 | Extension Study of RA101495 for Patients With PNH Who Have Completed a Zilucoplan (RA101495) Clinical Study | A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: Zilucoplan (RA101495) | Ra Pharmaceuticals, Inc. | NULL | Terminated | 18 Years | N/A | All | 19 | Phase 2 | United States;Australia;Canada;Finland;Germany;Hungary;New Zealand;United Kingdom;Denmark |
| 3 | EUCTR2016-003523-34-FI (EUCTR) | 06/04/2017 | 27/12/2016 | Extension Study of RA101495 in Paroxysmal Nocturnal Hemoglobinuria (PNH) | A Multicenter, Open-label, Uncontrolled, Extension Study of RA101495 in Subjects with Paroxysmal Nocturnal Hemoglobinuria Who Have Completed a RA101495 Clinical Study | Paroxysmal Nocturnal Hemoglobinuria (PNH) 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: Zilucoplan Product Code: RA101495 INN or Proposed INN: Zilucoplan Other descriptive name: Synthetic 15-amino-acid macrocyclic peptide acylated with a ethyleneglycol24 palmitoylated linker | Ra Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 28 | Phase 2 | United States;Hungary;Finland;Denmark;Australia;Germany;United Kingdom;New Zealand |