Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD

Part of paid clinical trials in Austin, Texas.

Sponsor
Scholar Rock, Inc.
Study ID
NCT07435129
Phase
PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • FSHD
  • Facioscapulohumeral Muscular Dystrophy

Eligibility Criteria

Sex
ALL
Age
18 Years - 60 Years
Healthy Volunteers
Not accepted

Interventions

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

Study Details

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

Key Dates

First listed
Feb 27, 2026
Start date
Jul 30, 2026
Status verified
Aug 2026
Primary completion
Jun 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
60 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Apitegromab
    10 mg/kg IV
  • Placebo Comparator: Placebo
    Placebo IV

Primary Outcome Measure

Assess the efficacy of apitegromab compared with placebo in participants with FSHD [ Time Frame: 52 Weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
National Neuromuscular Research InstituteAustinTexas78759
Marisol Barrientos Garcia
[email protected]
512-920-0140

Find similar trials in Austin, TX

By research site
National Neuromuscular Research Institute· Austin, TX

Related Studies