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Terminated Phase 2 Interventional Results available

Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

ClinicalTrials.gov ID: NCT04264442

Public ClinicalTrials.gov record NCT04264442. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

ClinicalTrials.gov public records Last synced Oct 21, 2026, 1:11 AM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

Official title

A Phase 2, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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.

Study identification

NCT ID
NCT04264442
Recruitment status
Terminated
Study type
Interventional
Phase
Phase 2
Lead sponsor
Fulcrum Therapeutics
Industry
Enrollment
76 participants

Conditions and interventions

Eligibility (public fields only)

Age range
18 Years to 65 Years
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Feb 13, 2020 (Actual)
Primary completion
Nov 7, 2024 (Actual)
Completion
Nov 7, 2024 (Actual)
Last update posted
Sep 30, 2025

2020 – 2024

United States locations

U.S. sites
12
U.S. states
11
U.S. cities
12
Facility City State ZIP Site status
University of California Irvine Irvine California 92868 —
University of California Los Angeles (UCLA) Los Angeles California 90095 —
University of Florida Gainesville Florida 32610 —
University of Kansas Medical Center Kansas City Kansas 66160 —
Kennedy Krieger Institute Baltimore Maryland 21205 —
University of Massachusetts Memorial Medical Center Worcester Massachusetts 01655 —
Washington University School of Medicine St Louis Missouri 63110 —
University of Rochester Medical Center Rochester New York 14642 —
Ohio State University Columbus Ohio 43221 —
University of Utah Salt Lake City Utah 84132 —
Virginia Commonwealth University Richmond Virginia 23298 —
University of Washinton Medical Center Seattle Washington 98195 —

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 5 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT04264442, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Sep 30, 2025 · Synced Oct 21, 2026

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Open the official record

The complete public registry record, listed eligibility criteria, and available contact information for NCT04264442 live on ClinicalTrials.gov.

View official ClinicalTrials.gov record →