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NCT05397470 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
A Phase 3 study, sponsored by Fulcrum Therapeutics.
- Terminated
- Registry status
- Phase 3
- Development phase
- 260
- Enrollment target
NCT05397470: Clinical Trial Phase 3 study, sponsored by Fulcrum Therapeutics.
NCT05397470 is a Phase 3 study that was terminated before completion, run by Fulcrum Therapeutics. The registered enrollment target is 260 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05397470, a Phase 3 study, was terminated before completion, sponsored by Fulcrum Therapeutics.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 260 participants
- Enrollment target
Study 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.
Primary Outcome
Participants are instructed to complete a simple set of standardized movements of each arm centered around the shoulder joint. These arm movements are captured and quantitated with the use of a video camera. The RWS is a clinical outcome measure that measures the relative surface area that a participant may reach with an outstretched arm. Responses are rated on a scale of 0 (no reachable workspace) to 1.25 (maximal reachable workspace). Higher scores indicate better outcomes. Baseline is the las
Interventions
- DRUG Placebo oral tablet
- DRUG Losmapimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 260 participants |
| Start Date | 2022-06-16 |
| Est. Completion | 2024-11-19 |
| Phase | Phase 3 |
Why NCT05397470 stopped before completion
NCT05397470 is an interventional study that assigns participants to a tested intervention. The registered 260 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (66% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT05397470 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT05397470 about?
NCT05397470 is a clinical study titled "Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)". 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 i...
What is the current status of trial NCT05397470?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 260 participants. The study started on 2022-06-16. Estimated completion is 2024-11-19.
What interventions are being tested in trial NCT05397470?
The interventions under investigation include: Placebo oral tablet (DRUG), Losmapimod (DRUG).
Who is sponsoring clinical trial NCT05397470?
This trial is sponsored by Fulcrum Therapeutics, which has 8 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT05397470's enrollment target sits among peer trials
260 1230th of 2000 higher than 767 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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