MedTrace Logo

Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

NCT05397470 · Status: TERMINATED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 260

Last updated 2025-11-10

Study results available
· View outcomes & findings →

Summary

This is a study to evaluate the safety and efficacy of losmapimod in treating participants with Facioscapulohumeral Muscular Dystrophy (FSHD). Participants diagnosed with Facioscapulohumeral muscular dystrophy type 1 (FSHD1) or Facioscapulohumeral muscular dystrophy type 2 (FSHD2) will participate in Part A (Placebo-controlled treatment period) and will be randomized in a 1:1 ratio to receive losmapimod 15 milligrams (mg) or placebo orally twice daily (BID). Upon completion of Part A, participants will have the option to rollover into Part B (open-label extension) to evaluate the long-term safety, tolerability, and efficacy of losmapimod and will receive losmapimod 15 mg orally BID.

Conditions

  • Facioscapulohumeral Muscular Dystrophy (FSHD)

Interventions

DRUG

Losmapimod

Losmapimod 15 mg will be administered BID by mouth along with food.

DRUG

Placebo oral tablet

Placebo will be administered BID by mouth along with food.

Sponsors & Collaborators

  • Fulcrum Therapeutics

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-06-16
Primary Completion
2024-11-19
Completion
2024-11-19
FDA Drug
Yes

Countries

  • United States
  • Canada
  • Denmark
  • France
  • Germany
  • Italy
  • Netherlands
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05397470 on ClinicalTrials.gov