Phase 2 Study Evaluating Apitegromab for the Treatment of FSHD
Trial statusNot yet recruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-60
SponsorScholar Rock, Inc.
About this trial
A randomized Phase 2 study to evaluate the efficacy and safety of apitegromab as a monotherapy in participant with FSHD
Eligibility criteria
Qualifiers
Male or female participants, 18 to 60 years of age at the time of informed consent.
Genetic diagnosis of FSHD Type 1 or FSHD Type 2, confirmed with the appropriate documentation from an accredited laboratory
Clinical severity score of 1.5 to 3.0 (Ricci score; range 0 to 5), inclusive, at screening
Baseline 10-meter walk/run test time ≤5 seconds
Disqualifiers
Prior history of a hypersensitivity reaction to a mAb or recombinant protein bearing an Fc domain (eg, a soluble receptor-Fc fusion protein), apitegromab, or excipients of apitegromab
Treatment with other investigational drugs in a clinical trial within 3 months or 5 half-lives, whichever is longer, before screening
Previous treatment with apitegromab, or with other anti-myostatin therapies, including activin receptor antagonists
Current or prior use of anabolic steroids, growth hormones, glucagon-like peptide-1 receptor agonist or other substances with known effects on muscle.
Trial design
Treatments tested in this trial
- Apitegromab
- Placebo
Treatment groups
60 Participants
are divided into 2 treatment groupsLocations
Sponsors and collaborators
Source ClinicalTrials.gov