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NCT04003974 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)
A Phase 2 study, sponsored by Fulcrum Therapeutics.
- Completed
- Registry status
- Phase 2
- Development phase
- 80
- Enrollment target
NCT04003974: Completed Phase 2 study, sponsored by Fulcrum Therapeutics.
NCT04003974 is a Phase 2 study that has completed, run by Fulcrum Therapeutics. The registered enrollment target is 80 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04003974, a Phase 2 study, has completed, sponsored by Fulcrum Therapeutics.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 80 participants
- Enrollment target
Study Summary
This is a study to evaluate the safety and efficacy of Losmapimod in treating patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.
Primary Outcome
Skeletal muscle biopsies were collected at Baseline and post-Baseline. DUX4 activity in skeletal muscle biopsies was assessed by measuring expression levels of a panel of 6 genes known to be regulated by DUX4. Expression levels of genes were measured using a validated quantitative RT-PCR assay and expressed as Ct (PCR cycles). Raw Ct for each of the 6 genes was normalized to the specified reference genes to generate a normalized Ct. The DUX4 activity is the average of the normalized Cts of each
Interventions
- DRUG Placebo oral tablet
- DRUG Losmapimod oral tablet
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 80 participants |
| Start Date | 2019-08-09 |
| Est. Completion | 2021-01-28 |
| Phase | Phase 2 |
What the finished NCT04003974 record still lists
NCT04003974 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 80 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (40% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo oral tablet is the first listed.
NCT04003974 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04003974 about?
NCT04003974 is a clinical study titled "Efficacy and Safety of Losmapimod in Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD)". This is a study to evaluate the safety and efficacy of Losmapimod in treating patients with Facioscapulohumeral Muscular Dystrophy (FSHD) over 48 weeks.
What is the current status of trial NCT04003974?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 80 participants. The study started on 2019-08-09. Estimated completion is 2021-01-28.
What interventions are being tested in trial NCT04003974?
The interventions under investigation include: Placebo oral tablet (DRUG), Losmapimod oral tablet (DRUG).
Who is sponsoring clinical trial NCT04003974?
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 NCT04003974's enrollment target sits among peer trials
80 842nd of 2000 higher than 1,117 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 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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