A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multicenter, 52-Week Study Evaluating the Efficacy and Safety of Apitegromab in Participants With Facioscapulohumeral Muscular Dystrophy (FORGE)
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
SUMMARY
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 60
Healthy Volunteers: f
View:
• Male or female participants, 18 to 60 years of age at the time of informed consent.
• Genetic diagnosis of FSHD Type 1 or FSHD Type 2, confirmed with the appropriate documentation from an accredited laboratory
• Clinical severity score of 1.5 to 3.0 (Ricci score; range 0 to 5), inclusive, at screening
• Baseline 10-meter walk/run test time ≤5 seconds
Locations
United States
Texas
National Neuromuscular Research Institute
RECRUITING
Austin
Contact Information
Primary
Scholar Rock, Inc. Clinical Trials Administration
MedicalInformation@scholarrock.com
857-259-3860
Time Frame
Start Date: 2026-07-30
Estimated Completion Date: 2028-12
Participants
Target number of participants: 60
Treatments
Experimental: Apitegromab
10 mg/kg IV
Placebo_comparator: Placebo
Placebo IV
Related Therapeutic Areas
Sponsors
Leads: Scholar Rock, Inc.