Apitegromab
Sponsors
Scholar Rock Inc., Scholar Rock, Inc.
Conditions
Anti-myostatinAtrophyFSHDFacioscapulohumeral Muscular DystrophyMuscular AtrophyMuscular Atrophy, SpinalNeuromuscular DiseasesNeuromuscular Manifestations
Phase 2
Efficacy and Safety of Apitegromab for the Treatment of Adults Who Are Overweight or Obese
CompletedNCT06445075
Start: 2024-05-21End: 2025-06-17Updated: 2026-01-23
A Study to Evaluate How Apitegromab Works in Subjects Who Are Less Than 2 Years Old and Have Spinal Muscular Atrophy
RecruitingNCT07047144
Start: 2025-09-15End: 2029-03-01Target: 52Updated: 2026-09-14
A Phase 2, Double-Blind Study to Evaluate the Pharmacokinetics, Pharmacodynamics, Efficacy, and Safety of Apitegromab in Subjects <2 Years Old With Spinal Muscular Atrophy (SMA) (OPAL)
RecruitingCTIS2024-520130-29-00
Start: 2025-12-17Target: 30Updated: 2025-11-20
Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
RecruitingNCT07435129
Start: 2026-07-30End: 2028-12-01Target: 60Updated: 2026-09-02
Phase 3
Efficacy and Safety of Apitegromab in Patients With Later-Onset Spinal Muscular Atrophy Treated With Nusinersen or Risdiplam
CompletedNCT05156320
Start: 2022-04-14End: 2024-12-18Updated: 2026-01-22
Long-Term Safety & Efficacy of Apitegromab in Patients With SMA Who Completed Previous Trials of Apitegromab
Active, not recruitingNCT05626855
Start: 2023-04-17End: 2029-05-02Updated: 2026-09-01
An 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)
Active, not recruitingCTIS2024-511654-42-00
Start: 2023-06-28Target: 125Updated: 2025-08-04