NCT07435129

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)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: Scholar Rock, Inc. · Industry
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This Phase 2, randomized, double-blind, placebo-controlled, multicenter study is designed to evaluate the efficacy, safety, and tolerability of apitegromab in participants with facioscapulohumeral muscular dystrophy (FSHD)

Conditions

• Facioscapulohumeral Muscular Dystrophy
• FSHD

Interventions

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

Timeline

• Start date: 2026-08-01
• Primary completion: 2028-06-01
• Completion: 2028-12-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Regulatory

• FDA-regulated drug study