Trial · NCT05397470
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
NCT05397470, Phase 3, Terminated, Fulcrum Therapeutics; results first posted 2025-11-10
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH). Trials, record NCT05397470. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05397470
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
- NCT number
- NCT05397470
- Status
- Terminated
- Phases
- Phase 3
- Enrollment
- 260 participants, actual
- Lead sponsor
- Fulcrum Therapeutics
- Conditions
- Facioscapulohumeral Muscular Dystrophy (FSHD)
- Interventions
- Losmapimod, Placebo oral tablet
- First posted
- 2022-05-31
- Last updated
- 2025-11-10
- Results first posted
- 2025-11-10
Source ClinicalTrials.gov
Registered outcomes19
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | 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 | Baseline (Day 1) and at Week 48 | 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. |
| Primary | Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5% | Week 48 to Week 127 | 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. |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Week 48 to Week 127 | 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. |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters | Week 48 to Week 127 | 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 |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Urinalysis | Week 48 to Week 127 | Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, potential of Hydrogen (pH), specific gravity, ketones, glucose. |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Vital Parameters | Week 48 to Week 127 | 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. |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Week 48 to Week 127 | Twelve-lead ECGs were performed after participants has been recumbent for at least 5 minutes. |
| Primary | Part B: Number of Participants With Clinically Significant Changes in Physical Examinations | Week 48 to Week 127 | 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. |
| Secondary | Part A: Change From Baseline in Quality of Life in Neurologic Disorders Upper Extremity (Neuro-QoL UE) Scale at Week 48 | Baseline (Day 1) and at Week 48 | The Neuro-QoL Upper Extremity (UE) scale is a patient-reported outcome measure designed to assess upper limb function in individuals with neurologic conditions. It evaluates a participant's self-reported difficulty in performing activities for daily living (ADLs) involving digital, manual, and reach-related function and self-care. Responses are divided into 5 ordinal levels (1 = unable to do, 2 = with much difficulty, 3 = with some difficulty, 4 = with a little difficulty, 5 = without any difficulty). Lower scores indicate worse symptoms. Change from Baseline was calculated as the post-treatment value minus the value at Baseline. |
| Secondary | Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48 | At Week 48 | The Patient Global Impression of Change (PGIC) is a standard participant-report outcome that measures the participant's self-reported change in health status compared to the start of the study. The PGIC uses a single question and 7-point patient self-reporting scale of overall improvement during treatment ranging from 1 (very much improved) to 7 (very much worse). Higher scores indicate worse symptoms. |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 registered outcomesOutcomes19
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | 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 | Baseline (Day 1) and at Week 48 | Full Analysis Set comprised of all participants with FSHD1 or FSHD2 who are randomized and receive at least 1 dose of study drug in the placebo-controlled treatment period. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | LEAST_SQUARES_MEAN |
| PRIMARY | Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5% | Week 48 to Week 127 | Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Week 48 to Week 127 | Open-label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters | Week 48 to Week 127 | Open-label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Urinalysis | Week 48 to Week 127 | Open-label Analysis Set | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Vital Parameters | Week 48 to Week 127 | Open-label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Week 48 to Week 127 | Open-label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Part B: Number of Participants With Clinically Significant Changes in Physical Examinations | Week 48 to Week 127 | Open-label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Part A: Change From Baseline in Quality of Life in Neurologic Disorders Upper Extremity (Neuro-QoL UE) Scale at Week 48 | Baseline (Day 1) and at Week 48 | Full Analysis Set. Only those participants with data available at specified timepoints has been presented. | Scores on a scale | MEAN |
| SECONDARY | Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48 | At Week 48 | Full Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
1 to 10 of 19Source ClinicalTrials.gov
See all 19 outcomesResults by group48
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| 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 | Part A: Losmapimod 15 Milligrams (mg) | 0.013 | Standard Error 0.007 | Scores on a scale | |
| 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 | Part A: Placebo | 0.010 | Standard Error 0.007 | Scores on a scale | |
| Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5% | Part B: Open Label Treatment Period: Losmapimod | Any serious TEAE | 7 | Participants | |
| Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5% | Part B: Open Label Treatment Period: Losmapimod | Any non-serious TEAE > 5% | 94 | Participants | |
| Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants | ||
| Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants | ||
| Part B: Number of Participants With Clinically Significant Changes in Urinalysis | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants | ||
| Part B: Number of Participants With Clinically Significant Changes in Vital Parameters | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants | ||
| Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants | ||
| Part B: Number of Participants With Clinically Significant Changes in Physical Examinations | Part B: Open Label Treatment Period: Losmapimod | 0 | Participants |
1 to 10 of 48Source ClinicalTrials.gov
See all 48 results by groupParticipant flow18
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Part A: PCT Period (Up to 48 Weeks) | STARTED | Part A: Losmapimod 15 Milligrams (mg) | 130 | |
| Part A: PCT Period (Up to 48 Weeks) | STARTED | Part A: Placebo | 130 | |
| Part A: PCT Period (Up to 48 Weeks) | STARTED | Part B: Losmapimod 15 mg OLE | 0 | |
| Part A: PCT Period (Up to 48 Weeks) | COMPLETED | Part A: Losmapimod 15 Milligrams (mg) | 127 | |
| Part A: PCT Period (Up to 48 Weeks) | COMPLETED | Part A: Placebo | 126 | |
| Part A: PCT Period (Up to 48 Weeks) | COMPLETED | Part B: Losmapimod 15 mg OLE | 0 | |
| Part A: PCT Period (Up to 48 Weeks) | NOT COMPLETED | Part A: Losmapimod 15 Milligrams (mg) | 3 | |
| Part A: PCT Period (Up to 48 Weeks) | NOT COMPLETED | Part A: Placebo | 4 | |
| Part A: PCT Period (Up to 48 Weeks) | NOT COMPLETED | Part B: Losmapimod 15 mg OLE | 0 | |
| Part B: OLE Period (Up to Week 127) | STARTED | Part A: Losmapimod 15 Milligrams (mg) | 0 |
1 to 10 of 18Source ClinicalTrials.gov
See all 18 participant flowAdverse events102
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | COVID-19 | Infections and infestations | Part A: Placebo-controlled Treatment Period: Losmapimod | 16 | 130 | |
| other | COVID-19 | Infections and infestations | Part A: Placebo-controlled Treatment Period: Placebo | 13 | 130 | |
| other | COVID-19 | Infections and infestations | Part B: Open Label Treatment Period: Losmapimod | 9 | 249 | |
| other | Influenza | Infections and infestations | Part A: Placebo-controlled Treatment Period: Losmapimod | 6 | 130 | |
| other | Influenza | Infections and infestations | Part A: Placebo-controlled Treatment Period: Placebo | 8 | 130 | |
| other | Influenza | Infections and infestations | Part B: Open Label Treatment Period: Losmapimod | 5 | 249 | |
| other | Nasopharyngitis | Infections and infestations | Part A: Placebo-controlled Treatment Period: Losmapimod | 30 | 130 | |
| other | Nasopharyngitis | Infections and infestations | Part A: Placebo-controlled Treatment Period: Placebo | 29 | 130 | |
| other | Nasopharyngitis | Infections and infestations | Part B: Open Label Treatment Period: Losmapimod | 19 | 249 | |
| other | Arthralgia | Musculoskeletal and connective tissue disorders | Part A: Placebo-controlled Treatment Period: Losmapimod | 6 | 130 |
1 to 10 of 102Source ClinicalTrials.gov
See all 102 adverse eventsAdverse event totals9
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Part A: Placebo-controlled Treatment Period: Losmapimod | 0 | 130 |
| Total, all-cause mortality | Part A: Placebo-controlled Treatment Period: Placebo | 1 | 130 |
| Total, all-cause mortality | Part B: Open Label Treatment Period: Losmapimod | 0 | 249 |
| Total, other adverse events | Part A: Placebo-controlled Treatment Period: Losmapimod | 122 | 130 |
| Total, other adverse events | Part A: Placebo-controlled Treatment Period: Placebo | 112 | 130 |
| Total, other adverse events | Part B: Open Label Treatment Period: Losmapimod | 94 | 249 |
| Total, serious adverse events | Part A: Placebo-controlled Treatment Period: Losmapimod | 5 | 130 |
| Total, serious adverse events | Part A: Placebo-controlled Treatment Period: Placebo | 8 | 130 |
| Total, serious adverse events | Part B: Open Label Treatment Period: Losmapimod | 7 | 249 |
Source ClinicalTrials.gov
Papers4
The papers the trial lists on ClinicalTrials.gov.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Vital Parameters | Trial comparisons |
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Physical Examinations | Trial comparisons |
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Trial comparisons |
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Urinalysis | Trial comparisons |
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Hematology Parameters | Trial comparisons |
| Part A: Losmapimod 15 Milligrams (mg) vs Part A: Placebo: Part A: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters | Trial comparisons |
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05397470
GET https://conductscience.org/api/trials/v1/NCT05397470/results?page=2