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NCT04264442 · ClinicalTrials.gov registry record · Phase 2
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
A Phase 2 study, sponsored by Fulcrum Therapeutics.
- Terminated
- Registry status
- Phase 2
- Development phase
- 76
- Enrollment target
NCT04264442: Clinical Trial Phase 2 study, sponsored by Fulcrum Therapeutics.
NCT04264442 is a Phase 2 study that was terminated before completion, run by Fulcrum Therapeutics. The registered enrollment target is 76 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04264442, a Phase 2 study, was terminated before completion, sponsored by Fulcrum Therapeutics.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 76 participants
- Enrollment target
Study Summary
This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.
Primary Outcome
A TEAE is an adverse event that begins on or after the first dose of study drug and on or before the stop of study drug plus 7 days or begins before the first dose of study drug and worsens on or after the first dose of study drug and on or before the stop of study drug plus 7 days. An adverse event with completely missing onset and end dates was considered as TEAE. An adverse event with missing onset date but the end date is on or after the first dose of study drug and before the stop of study
Interventions
- DRUG Losmapimod
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 76 participants |
| Start Date | 2020-02-13 |
| Est. Completion | 2024-11-07 |
| Phase | Phase 2 |
Why NCT04264442 stopped before completion
NCT04264442 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 76 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (43% lower).
The record links to 0 conditions, and to 1 intervention - of which Losmapimod is the first listed.
NCT04264442 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04264442 about?
NCT04264442 is a clinical study titled "Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)". This study is an open-label extension to evaluate the safety and tolerability of long-term dosing of Losmapimod in patients with FSHD1 who participated in the ReDux4 study.
What is the current status of trial NCT04264442?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 76 participants. The study started on 2020-02-13. Estimated completion is 2024-11-07.
What interventions are being tested in trial NCT04264442?
The interventions under investigation include: Losmapimod (DRUG).
Who is sponsoring clinical trial NCT04264442?
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 NCT04264442's enrollment target sits among peer trials
76 893rd of 2000 higher than 1,101 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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