NCT05397470Phase 3Terminated

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

Compare the available registry edits below. Primary completion is the date data collection ends for the main study measures; it does not tell you when results will be published.

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Primary completion2024-11-19Actual

Enrollment · participants260Actual

Source updated2025-11-10Last update listed in the registry record

Version history

Changes to this trial

Last 12 months

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Study details

Conditions studied

Facioscapulohumeral Muscular Dystrophy (FSHD)

Treatments or interventions studied

LosmapimodDrug
Placebo oral tabletDrug

Primary outcomes · main study measures

Read the study measures

measure: Part A: Change From Baseline in Total Relative Surface Area (RSA) Quadrants 1 to 5 (Q1-Q5) With 500 Grams (g) Wrist Weight Averaged Over Both Arms as Assessed by Reachable Workspace (RWS) at Week 48; description: 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 last non-missing evaluation prior to first dose of study drug. Change from Baseline was calculated as the post-treatment value minus the value at Baseline.; timeFrame: Baseline (Day 1) and at Week 48; measure: Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5%; description: Treatment-emergent adverse event is an AE that begins on or after the first dose of study drug and on or before the stop of study drug + 35 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 + 35 days. A SAE is defined as an AE that results in any of the following outcomes: death; life-threatening adverse event; inpatient hospitalization or prolongation of existing hospitalization; persistent or significant incapacity or substantial disruption of the ability to conduct normal life functions; congenital anomaly/birth defect.; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters; description: Blood samples were collected for the analysis of chemistry parameters: Glucose, sodium, potassium, calcium, inorganic phosphate, total protein, albumin, blood urea nitrogen, creatinine, total bilirubin, direct bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase and creatine phosphokinase.; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters; description: Blood samples were collected for the analysis of hematology parameters: hemoglobin (including mean corpuscular volume), mean corpuscular hemoglobin, mean corpuscular hemoglobin concentration, hematocrit, red blood cell count, total white blood cell count, platelet count. Differential blood counts, including basophils, eosinophils, neutrophils, lymphocytes, and monocytes; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Urinalysis; description: Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, potential of Hydrogen (pH), specific gravity, ketones, glucose.; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Vital Parameters; description: Vital parameters including pulse rate, respiration rate, blood pressure, and temperature were measured in seated or recumbent for at least 5 minutes. Data for number of participants with abnormal clinically significant changes for vital signs have been presented.; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters; description: Twelve-lead ECGs were performed after participants has been recumbent for at least 5 minutes.; timeFrame: Week 48 to Week 127; measure: Part B: Number of Participants With Clinically Significant Changes in Physical Examinations; description: Physical examinations included an evaluation of body systems, including but not limited to the following: skin; head, eyes, ears, nose, and throat; respiratory system; cardiovascular system; abdomen (liver, spleen); lymph nodes; neurological system; and musculoskeletal system.; timeFrame: Week 48 to Week 127

History coverage

Research sample: selected versions from May 2023 onward plus a preceding baseline where available. Only selected fields were retained; endpoint measures were truncated to 300 characters. This is not complete trial or sponsor history. Daily snapshots begin when collection starts.

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