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 | 2 |
| 11 | 重症筋無力症 | 7 |
| 62 | 発作性夜間ヘモグロビン尿症 | 4 |
| 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 | NCT04436497 (ClinicalTrials.gov) | July 29, 2020 | 1/6/2020 | HEALEY ALS Platform Trial - Regimen A Zilucoplan | HEALEY ALS Platform Trial - Regimen A Zilucoplan | Amyotrophic Lateral Sclerosis | Drug: Zilucoplan;Drug: Matching Placebo | Merit E. Cudkowicz, MD | Ra Pharmaceuticals | Enrolling by invitation | 18 Years | N/A | All | 160 | Phase 2;Phase 3 | United States |
| 2 | 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 | Merit E. Cudkowicz, MD | Massachusetts General Hospital | Recruiting | 18 Years | N/A | All | 480 | Phase 2;Phase 3 | United States |
| 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-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 | ||
| 2 | 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 | ||
| 3 | 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 | Recruiting | 18 Years | N/A | All | 200 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom |
| 4 | 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 | ||
| 5 | 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 | ||
| 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 |
| 6 | NCT04115293 (ClinicalTrials.gov) | October 1, 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 | Recruiting | 18 Years | 75 Years | All | 130 | Phase 3 | United States;Canada;France;Germany;Italy;Japan;Norway;Spain;United Kingdom |
| 7 | 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 | Active, not recruiting | 18 Years | 85 Years | All | 44 | Phase 2 | United States;Canada |
| 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 | NULL | Active, not recruiting | 18 Years | N/A | All | 28 | Phase 2 | United States;Australia;Denmark;Finland;Germany;Hungary;New Zealand;United Kingdom |
| 3 | NCT03030183 (ClinicalTrials.gov) | April 17, 2017 | 20/1/2017 | Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients Who Have an Inadequate Response to Eculizumab | A Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Who Have an Inadequate Response to Eculizumab | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: Zilucoplan (RA101495) | Ra Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 3 | Phase 2 | United States |
| 4 | NCT03078582 (ClinicalTrials.gov) | March 8, 2017 | 8/3/2017 | Phase 2 Safety and Efficacy Study of Zilucoplan (RA101495) to Treat PNH Patients | Phase 2 Multicenter, Open-Label, Uncontrolled Study to Evaluate the Safety, Tolerability, Efficacy, Pharmacokinetics, and Pharmacodynamics of RA101495 in Subjects With Paroxysmal Nocturnal Hemoglobinuria | Paroxysmal Nocturnal Hemoglobinuria (PNH) | Drug: Zilucoplan (RA101495) | Ra Pharmaceuticals | NULL | Completed | 18 Years | N/A | All | 26 | Phase 2 | Australia;Canada;Denmark;Finland;Germany;Hungary;New Zealand;United Kingdom |