Apitegromab ( DrugBank: Apitegromab )


1 disease
告示番号疾患名(ページ内リンク)臨床試験数
3脊髄性筋萎縮症7

3. 脊髄性筋萎縮症


臨床試験数 : 237 薬物数 : 123 - (DrugBank : 29) / 標的遺伝子数 : 51 - 標的パスウェイ数 : 75
No.TrialIDDate_
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Public_titleScientific_titleConditionInterventionPrimary_
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agemin
Inclusion_
agemax
Inclusion_
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size
PhaseCountries
1NCT05626855
(ClinicalTrials.gov)
April 24, 20237/11/2022Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab-ONYXAn Open-Label, Multicenter, Extension Trial to Evaluate the Long-Term Safety and Efficacy of Apitegromab in Patients With Type 2 and Type 3 Spinal Muscular Atrophy Who Completed Previous Investigational Trials of ApitegromabSpinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type II;SMA;Neuromuscular Diseases;Muscular Atrophy;Atrophy;Muscular Atrophy, Spinal;Neuromuscular Manifestations;Anti-myostatinDrug: ApitegromabScholar Rock, Inc.NULLNot yet recruiting2 YearsN/AAll260Phase 3United States;Belgium;Italy;Netherlands;Poland;Spain
2EUCTR2021-005314-34-ES
(EUCTR)
11/05/202209/03/2022Phase 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.NULLAuthorised-recruitment may be ongoing or finishedFemale: yes
Male: yes
204Phase 3France;United States;Poland;Belgium;Spain;Netherlands;Germany;United Kingdom;Italy
3NCT05156320
(ClinicalTrials.gov)
February 24, 20221/12/2021Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy 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 TherapySpinal Muscular Atrophy;Spinal Muscular Atrophy Type 3;Spinal Muscular Atrophy Type 2;SMA;Neuromuscular Diseases;Muscular Atrophy;Atrophy;Muscular Atrophy, Spinal;Neuromuscular Manifestations;Anti-myostatinDrug: Apitegromab;Drug: PlaceboScholar Rock, Inc.NULLRecruiting2 Years21 YearsAll204Phase 3Germany;Italy;Netherlands;Poland;Spain;United Kingdom;Belgium;France;United States
4EUCTR2018-004383-65-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
5EUCTR2021-005314-34-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
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
7EUCTR2022-001771-14-NL
(EUCTR)
20/12/2022Long-Term Safety and Efficacy of Apitegromab in Patients with Type 2 and Type 3 Spinal Muscular Atrophy Who Completed Previous Investigational Trials of ApitegromabAn Open-Label, Multicenter, Extension Trial to Evaluate the Long-Term Safety and Efficacy of Apitegromab in Patients with Type 2 and Type 3 Spinal Muscular Atrophy Who Completed Previous Investigational Trials of Apitegromab - ONYX 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
260Phase 3France;United States;Belgium;Spain;Poland;Germany;Netherlands;United Kingdom;Italy