3. 脊髄性筋萎縮症 Spinal muscular atrophy Clinical trials / Disease details


臨床試験数 : 217 薬物数 : 149 - (DrugBank : 33) / 標的遺伝子数 : 54 - 標的パスウェイ数 : 80

  
7 trials found
No.TrialIDDate_
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PhaseCountries
1EUCTR2018-004383-65-DE
(EUCTR)
21/11/201926/07/2019A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular AtrophyPhase 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.NULLNot Recruiting Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Spain;Netherlands;Germany;Italy
2EUCTR2018-004383-65-NL
(EUCTR)
30/10/201903/04/2019A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular AtrophyPhase 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: Apitegromab
Other descriptive name: HUMAN ANTI-PROMYOSTATIN MONOCLONAL ANTIBODY
Product Name: SRK-015
INN or Proposed INN: Apitegromab
Other descriptive name: HUMAN ANTI-PROMYOSTATIN MONOCLONAL ANTIBODY
Scholar Rock, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
58Phase 2United States;Spain;Germany;Netherlands;Italy
3EUCTR2018-004383-65-IT
(EUCTR)
16/06/201925/01/2021A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular AtrophyPhase 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
Product Code: [NA]
INN or Proposed INN: SRK-015
Product Name: SRK-015
Product Code: [NA]
INN or Proposed INN: SRK-015
Scholar Rock, Inc.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
55Phase 2United States;Spain;Germany;Netherlands;Italy
4EUCTR2018-004383-65-ES
(EUCTR)
10/06/201912/04/2019A clinical study of a new possible treatment in patients with type 2 or 3 Spinal Muscular AtrophyPhase 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.NULLAuthorised-recruitment may be ongoing or finished Female: yes
Male: yes
55 Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): noUnited States;Canada;Spain;Netherlands;Germany;Italy
5NCT03921528
(ClinicalTrials.gov)
April 22, 201916/4/2019An Active Treatment Study of SRK-015 in Patients With Type 2 or Type 3 Spinal Muscular AtrophyPhase 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 ManifestationsBiological: SRK-015Scholar Rock, Inc.NULLActive, not recruiting2 Years21 YearsAll58Phase 2United States;Italy;Netherlands;Spain
6EUCTR2021-005314-34-BE
(EUCTR)
11/02/2022Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or RisdiplamPhase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE Spinal Muscular Atrophy (SMA)
MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Apitegromab
Product Code: SRK-015
INN or Proposed INN: Apitegromab
Scholar Rock, Inc.NULLNAFemale: yes
Male: yes
204Phase 3United States;France;Spain;Poland;Belgium;Netherlands;Germany;United Kingdom;Italy
7EUCTR2021-005314-34-NL
(EUCTR)
10/03/2022Phase 3 Active Treatment Trial to Evaluate the Efficacy and Safety of Apitegromab in Patients with Later-Onset Spinal Muscular Atrophy Who Are Being Treated with Nusinersen or RisdiplamPhase 3, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Apitegromab (SRK-015) in Patients with Later-Onset Spinal Muscular Atrophy Receiving Background Nusinersen or Risdiplam Therapy - SAPPHIRE Spinal Muscular Atrophy (SMA)
MedDRA version: 20.1;Level: LLT;Classification code 10041583;Term: Spinal muscular atrophy, unspecified;System Organ Class: 100000004850;Therapeutic area: Diseases [C] - Congenital, Hereditary, and Neonatal Diseases and Abnormalities [C16]
Product Name: Apitegromab
Product Code: SRK-015
INN or Proposed INN: Apitegromab
Scholar Rock, Inc.NULLNAFemale: yes
Male: yes
204Phase 3France;United States;Spain;Poland;Belgium;Germany;Netherlands;United Kingdom;Italy