A Phase 2 interventional study of Apitegromab and Placebo in Facioscapulohumeral Muscular Dystrophy and FSHD, sponsored by Scholar Rock, Inc.. Recruiting at 1 site in United States. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-09-02.
Sponsored by Scholar Rock, Inc. · Phase 2, Interventional, and Treatment
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD
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)
79 studies on the registry are indexed under Muscular Dystrophy, Facioscapulohumeral; 26 are open to participants now.
This study's planned enrollment of 60 is above the median of 48 across 49 interventional studies indexed under Muscular Dystrophy, Facioscapulohumeral.
Browse Muscular Dystrophy, Facioscapulohumeral studies →Scholar Rock, Inc. is the lead sponsor of 9 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Platelets
Blood cells that help blood clot. Too few raises the risk of bleeding and bruising. A usual adult range is about 150–400 × 10⁹/L (150,000–400,000 per µL); each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
10 mg/kg IV
Drug: Apitegromab
Placebo IV
Drug: Placebo
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.
Also known as: SRK-015
Placebo is administered every 4 weeks by intravenous (IV) infusion and does not contain the active ingredient.
Assess the efficacy of apitegromab compared with placebo in participants with FSHD
Percent change from baseline in total lean muscle volume (LMV) as measured by full body magnetic resonance imaging (MRI) at week 52
Time frame: 52 Weeks
Further assess the efficacy of apitegromab compared with placebo in participants with FSHD
Percent change from baseline in total LMV as measured by full body MRI at week 24
Time frame: 24 Weeks
Further assess the efficacy of apitegromab compared with placebo in participants with FSHD
Change from baseline in additional muscle parameters, such as muscle fat fraction at week 24 and week 52
Time frame: 24 Weeks and 52 Weeks
Further assess the efficacy of apitegromab compared with placebo in participants with FSHD
Change from baseline in additional muscle parameters, such as muscle fat infiltration, at week 24 and week 52
Time frame: 24 Weeks and 52 Weeks
Evaluate the pharmacokinetics of apitegromab in participants with FSHD
Serum concentrations of apitegromab
Time frame: 52 Weeks
Evaluate the pharmacodynamics of apitegromab in participants with FSHD
Serum concentrations of total latent myostatin
Time frame: 52 Weeks
Evaluate the safety and tolerability of apitegromab in participants with FSHD
Incidence of anti-drug antibodies against apitegromab in serum
Time frame: 52 Weeks
Evaluate the safety and tolerability of apitegromab in FSHD participants
Incidence of adverse events and serious adverse events
Time frame: 52 Weeks
Evaluate improvement(s) over time in motor function in participants with FSHD receiving apitegromab
Change from baseline in quantitative muscle testing in kilogram-force. Higher score indicates greater function.
Time frame: 52 Weeks
Evaluate improvement(s) over time in motor function in participants with FSHD receiving apitegromab
Change from baseline in relative surface area as assessed by reachable workspace. Higher score indicates greater function.
Time frame: 52 Weeks
Evaluate improvement(s) over time in motor function in participants with FSHD receiving apitegromab
Change from baseline in FSHD composite outcome measure (FSHD-COM) total score (0 - 72 scale; Higher score indicates greater impairment)
Time frame: 52 Weeks
Plan to share: No
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Studies of the drug tested here: Apitegromab
Muscular Dystrophy, Facioscapulohumeral →
Scholar Rock, Inc.