Srk-015 (DrugBank: -)
1 diseaseID | Disease name (Link within this page) | Number of trials |
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3 | Spinal muscular atrophy | 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 |
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1 | EUCTR2018-004383-65-DE (EUCTR) | 21/11/2019 | 26/07/2019 | A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular Atrophy | Phase 2 Active Treatment Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular Atrophy - The TOPAZ study | Later Onset Spinal Muscular Atrophy (SMA) MedDRA version: 20.0;Level: LLT;Classification code 10079415;Term: Spinal muscular atrophy type III;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079416;Term: Spinal muscular atrophy type II;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Scholar Rock, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 55 | Phase 2 | United States;Spain;Netherlands;Germany;Italy | |||
2 | EUCTR2018-004383-65-NL (EUCTR) | 30/10/2019 | 03/04/2019 | A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular Atrophy | Phase 2 Active Treatment Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular Atrophy - The TOPAZ study | Later Onset Spinal Muscular Atrophy (SMA) MedDRA version: 20.0;Level: LLT;Classification code 10079415;Term: Spinal muscular atrophy type III;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079416;Term: Spinal muscular atrophy type II;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Product Name: SRK-015 INN or Proposed INN: SRK-015 Other descriptive name: HUMAN ANTI-PROMYOSTATIN MONOCLONAL ANTIBODY Product Name: SRK-015 INN or Proposed INN: SRK-015 Other descriptive name: HUMAN ANTI-PROMYOSTATIN MONOCLONAL ANTIBODY | Scholar Rock, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 2 | United States;Canada;Spain;Germany;Netherlands;Italy | ||
3 | EUCTR2018-004383-65-ES (EUCTR) | 10/06/2019 | 12/04/2019 | A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular Atrophy | Phase 2 Active Treatment Study to Evaluate the Efficacy and Safety of SRK-015 in Patients with Later-Onset Spinal Muscular Atrophy - The TOPAZ study | Later Onset Spinal Muscular Atrophy (SMA) MedDRA version: 20.0;Level: LLT;Classification code 10079415;Term: Spinal muscular atrophy type III;System Organ Class: 100000004850 MedDRA version: 20.0;Classification code 10079416;Term: Spinal muscular atrophy type II;System Organ Class: 100000004850 ;Therapeutic area: Diseases [C] - Nervous System Diseases [C10] | Scholar Rock, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 55 | Phase 2 | United States;Canada;Spain;Netherlands;Germany;Italy | |||
4 | NCT03921528 (ClinicalTrials.gov) | April 22, 2019 | 16/4/2019 | An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular Atrophy | Phase 2 Active Treatment Study to Evaluate the Efficacy and Safety of SRK-015 in Patients With Later-Onset Spinal Muscular Atrophy (TOPAZ) | Spinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscular Diseases;Muscular Atrophy;Atrophy;Muscular Atrophy, Spinal;Neuromuscular Manifestations | Biological: SRK-015 | Scholar Rock, Inc. | NULL | Active, not recruiting | 2 Years | 21 Years | All | 58 | Phase 2 | United States;Italy;Netherlands;Spain |