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NOT YET RECRUITING
NCT07435129
PHASE2

Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD

Sponsor: Scholar Rock, Inc.

View on ClinicalTrials.gov

Summary

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

Official title: 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)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

60

Start Date

2026-08

Completion Date

2028-12

Last Updated

2026-02-27

Healthy Volunteers

No

Interventions

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.