RecruitingPhase 2NCT07435129

Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD

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)

Sponsor

Scholar Rock, Inc.

Enrollment

60 participants

Start Date

Jul 30, 2026

Study Type

INTERVENTIONAL

Conditions

facioscapulohumeral muscular dystrophy FSHD

Summary

A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD

Eligibility

Min Age: 18 YearsMax Age: 60 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Apitegromab and a drug called Placebo for people with fshd and facioscapulohumeral muscular dystrophy. The study is currently recruiting participants at 1 location. People eligible for this study include aged 18 Years to 60 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGApitegromab

Apitegromab (SRK-015) is a fully human anti-promyostatin monoclonal antibody (mAb) that specifically binds to human pro/latent myostatin, inhibiting myostatin activation. Apitegromab will be administered every 4 weeks by intravenous (IV) infusion.

DRUGPlacebo

Placebo is administered every 4 weeks by intravenous (IV) infusion and does not contain the active ingredient.

Locations(1)

National Neuromuscular Research Institute

Austin, Texas, United States

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NCT07435129

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