Trial Outcomes & Findings for Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE) (NCT NCT04264442)
NCT ID: NCT04264442
Last Updated: 2025-09-30
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
76 participants
Primary outcome timeframe
Up to 57 months
Results posted on
2025-09-30
Participant Flow
Participants who completed either 24 or 48 weeks in the placebo-controlled treatment period of the parent study were eligible to enroll in the Open-Label Extension (OLE) phase. A total 76 participants entered the OLE) phase and received at least 1 dose of losmapimod. Of those, 39 were previously in the losmapimod group and 37 in the placebo group during the double-blind treatment period of study (NCT04003974) and met eligibility criteria for continued treatment.
Participants were analysed according to their original treatment assignment and their entry point into the OLE: Losmapimod 15 mg BID / Losmapimod 15 mg BID (from Week 24 or Week 48) and Placebo BID / Losmapimod 15 mg BID (from Week 24 or Week 48).
Participant milestones
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Overall Study
STARTED
|
76
|
|
Overall Study
COMPLETED
|
29
|
|
Overall Study
NOT COMPLETED
|
47
|
Reasons for withdrawal
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Overall Study
Lack of Efficacy
|
6
|
|
Overall Study
Lost to Follow-up
|
2
|
|
Overall Study
Sponsor Decision
|
23
|
|
Overall Study
Withdrawal by Subject
|
11
|
|
Overall Study
Study Termination
|
5
|
Baseline Characteristics
Efficacy and Safety of Losmapimod in Treating Subjects With Facioscapulohumeral Muscular Dystrophy (FSHD) With Open-Label Extension (OLE)
Baseline characteristics by cohort
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Age, Continuous
|
46.2 Years
STANDARD_DEVIATION 12.43 • n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
51 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
3 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
69 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
66 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
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.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs
Any serious TEAE
|
7 Participants
|
|
Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and TEAEs
Any TEAE
|
71 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
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.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set:
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
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
Blood samples were collected for the analysis of Serum coagulation parameters: International normalized ratio, prothrombin time, partial thromboplastin time.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, pH, specific gravity, ketones, glucose.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
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.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
Twelve-lead ECGs was performed after participants has been recumbent for at least 5 minutes.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
|
0 Participants
|
PRIMARY outcome
Timeframe: Up to 57 monthsPopulation: Open-Label Analysis Set.
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.
Outcome measures
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 Participants
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Number of Participants With Clinically Significant Changes in Physical Examinations
|
0 Participants
|
Adverse Events
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
Serious events: 7 serious events
Other events: 71 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 participants at risk
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Cardiac disorders
Acute myocardial infarction
|
2.6%
2/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Cardiac disorders
Coronary artery disease
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
General disorders
Ulcer haemorrhage
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Immune system disorders
Anaphylactic reaction
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal chest pain
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Endometrial cancer
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Nervous system disorders
Syncope
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Vascular disorders
Labile blood pressure
|
1.3%
1/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
Other adverse events
| Measure |
Losmapimod 15 Milligrams (mg) Twice Daily (BID)
n=76 participants at risk
Participants will continue to receive Losmapimod 15 mg (2×7.5 mg tablets/dose) BID until 90 days after commercial drug is available post regulatory approval or until the study is discontinued by the Sponsor (up to 60 months).
|
|---|---|
|
Cardiac disorders
Palpitations
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Eye disorders
Dry eye
|
7.9%
6/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Gastrointestinal disorders
Diarrhoea
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Gastrointestinal disorders
Food poisoning
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
General disorders
Fatigue
|
10.5%
8/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
General disorders
Pain
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Infections and infestations
Corona virus infection
|
48.7%
37/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Infections and infestations
Influenza
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Infections and infestations
Nasopharyngitis
|
19.7%
15/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Infections and infestations
Sinusitis
|
7.9%
6/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Infections and infestations
Urinary tract infection
|
10.5%
8/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Arthropod bite
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Contusion
|
14.5%
11/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Fall
|
36.8%
28/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Joint injury
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Ligament sprain
|
7.9%
6/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Skin abrasion
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Injury, poisoning and procedural complications
Skin laceration
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
18.4%
14/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
7.9%
6/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Muscle spasms
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
7.9%
6/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
11.8%
9/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Neck pain
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
9.2%
7/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Nervous system disorders
Headache
|
11.8%
9/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Psychiatric disorders
Anxiety
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Psychiatric disorders
Insomnia
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Renal and urinary disorders
Nephrolithiasis
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Respiratory, thoracic and mediastinal disorders
Sleep apnoea syndrome
|
6.6%
5/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.3%
4/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
|
Vascular disorders
Hypertension
|
9.2%
7/76 • Up to 57 months
Serious TEAEs and TEAEs were collected in Open-Label Analysis Set which comprised of all participants who completed 24 or 48 weeks of treatment in the placebo-controlled treatment period and received at least 1 dose of open-label losmapimod in the OLE.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER