Trial · NCT04264442
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
NCT04264442, Phase 2, Terminated, Fulcrum Therapeutics; results first posted 2025-09-30
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE). Trials, record NCT04264442. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT04264442
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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 Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
- NCT number
- NCT04264442
- Status
- Terminated
- Phases
- Phase 2
- Enrollment
- 76 participants, actual
- Lead sponsor
- Fulcrum Therapeutics
- Conditions
- Facioscapulohumeral Muscular Dystrophy (FSHD)
- Interventions
- Losmapimod
- First posted
- 2020-02-11
- Last updated
- 2025-09-30
- Results first posted
- 2025-09-30
Source ClinicalTrials.gov
Registered outcomes8
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs | Up to 57 months | 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 drug plus 7 days was considered a TEAE. |
| Primary | Number of Participants With Clinically Significant Changes in Chemistry Parameters | Up to 57 months | 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, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase and creatine phosphokinase. |
| Primary | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to 57 months | 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 | Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Up to 57 months | Blood samples were collected for the analysis of Serum coagulation parameters: International normalized ratio, prothrombin time, partial thromboplastin time. |
| Primary | Number of Participants With Clinically Significant Changes in Urinalysis | Up to 57 months | Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, pH, specific gravity, ketones, glucose. |
| Primary | Number of Participants With Clinically Significant Changes in Vital Parameters | Up to 57 months | 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 | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Up to 57 months | Twelve-lead ECGs was performed after participants has been recumbent for at least 5 minutes. |
| Primary | Number of Participants With Clinically Significant Changes in Physical Examinations | Up to 57 months | 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. |
Source ClinicalTrials.gov
Outcomes8
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Chemistry Parameters | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Hematology Parameters | Up to 57 months | Open-Label Analysis Set: | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Urinalysis | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Vital Parameters | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Participants With Clinically Significant Changes in Physical Examinations | Up to 57 months | Open-Label Analysis Set. | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group9
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | Any serious TEAE | 7 | Participants | |
| Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | Any TEAE | 71 | Participants | |
| Number of Participants With Clinically Significant Changes in Chemistry Parameters | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Hematology Parameters | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Urinalysis | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Vital Parameters | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants | ||
| Number of Participants With Clinically Significant Changes in Physical Examinations | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 76 | |
| Overall Study | COMPLETED | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 29 | |
| Overall Study | NOT COMPLETED | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 47 |
Source ClinicalTrials.gov
Adverse events42
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 | Palpitations | Cardiac disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 4 | 76 | |
| other | Dry eye | Eye disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 6 | 76 | |
| other | Diarrhoea | Gastrointestinal disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 4 | 76 | |
| other | Food poisoning | Gastrointestinal disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 5 | 76 | |
| other | Fatigue | General disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 8 | 76 | |
| other | Pain | General disorders | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 4 | 76 | |
| other | Corona virus infection | Infections and infestations | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 37 | 76 | |
| other | Influenza | Infections and infestations | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 4 | 76 | |
| other | Nasopharyngitis | Infections and infestations | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 15 | 76 | |
| other | Sinusitis | Infections and infestations | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 6 | 76 |
1 to 10 of 42Source ClinicalTrials.gov
See all 42 adverse eventsAdverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 0 | 76 |
| Total, other adverse events | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 71 | 76 |
| Total, serious adverse events | Losmapimod 15 Milligrams (mg) Twice Daily (BID) | 7 | 76 |
Source ClinicalTrials.gov
Papers7
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 comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
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/NCT04264442
GET https://conductscience.org/api/trials/v1/NCT04264442/events?page=2