Trial Outcomes & Findings for Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH) (NCT NCT05397470)
NCT ID: NCT05397470
Last Updated: 2025-11-10
Results Overview
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.
Recruitment status
TERMINATED
Study phase
PHASE3
Target enrollment
260 participants
Primary outcome timeframe
Baseline (Day 1) and at Week 48
Results posted on
2025-11-10
Participant Flow
This was a two-part study. Part A was a global, randomized, double-blind, placebo-controlled, parallel-group, multicenter study that enrolled up to 260 participants. Part B was an open-label extension phase in which approximately 249 participants from Part A rolled over to receive Losmapimod treatment.
Participants who completed 48 Weeks treatment period in Part A were enrolled in Part B. Part A of the study was completed as planned; however, Part B was terminated prematurely due to a Sponsor decision.
Participant milestones
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
Part B: Losmapimod 15 mg OLE
Participants who completed Part A rolled over into Part B and received Losmapimod 15 mg orally twice daily (BID) with food.
|
|---|---|---|---|
|
Part A: PCT Period (Up to 48 Weeks)
STARTED
|
130
|
130
|
0
|
|
Part A: PCT Period (Up to 48 Weeks)
COMPLETED
|
127
|
126
|
0
|
|
Part A: PCT Period (Up to 48 Weeks)
NOT COMPLETED
|
3
|
4
|
0
|
|
Part B: OLE Period (Up to Week 127)
STARTED
|
0
|
0
|
249
|
|
Part B: OLE Period (Up to Week 127)
COMPLETED
|
0
|
0
|
0
|
|
Part B: OLE Period (Up to Week 127)
NOT COMPLETED
|
0
|
0
|
249
|
Reasons for withdrawal
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
Part B: Losmapimod 15 mg OLE
Participants who completed Part A rolled over into Part B and received Losmapimod 15 mg orally twice daily (BID) with food.
|
|---|---|---|---|
|
Part A: PCT Period (Up to 48 Weeks)
Adverse Event
|
0
|
1
|
0
|
|
Part A: PCT Period (Up to 48 Weeks)
Protocol Violation
|
1
|
1
|
0
|
|
Part A: PCT Period (Up to 48 Weeks)
Withdrawal by Subject
|
2
|
1
|
0
|
|
Part A: PCT Period (Up to 48 Weeks)
Other
|
0
|
1
|
0
|
|
Part B: OLE Period (Up to Week 127)
Withdrawal by Subject
|
0
|
0
|
4
|
|
Part B: OLE Period (Up to Week 127)
Lost to Follow-up
|
0
|
0
|
1
|
|
Part B: OLE Period (Up to Week 127)
Study closed/terminated
|
0
|
0
|
244
|
Baseline Characteristics
Efficacy and Safety of Losmapimod in Treating Participants With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)
Baseline characteristics by cohort
| Measure |
Losmapimod 15 mg
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Matching Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
Total
n=260 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
43.4 Years
STANDARD_DEVIATION 12.3 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 12.0 • n=20 Participants
|
43.9 Years
STANDARD_DEVIATION 12.2 • n=40 Participants
|
|
Sex: Female, Male
Female
|
56 Participants
n=5 Participants
|
59 Participants
n=20 Participants
|
115 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
74 Participants
n=5 Participants
|
71 Participants
n=20 Participants
|
145 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=5 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
113 Participants
n=5 Participants
|
112 Participants
n=20 Participants
|
225 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
12 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=5 Participants
|
3 Participants
n=20 Participants
|
6 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
115 Participants
n=5 Participants
|
116 Participants
n=20 Participants
|
231 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
9 Participants
n=5 Participants
|
11 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Baseline (Day 1) and at Week 48Population: 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.
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.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=122 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=121 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
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
|
0.013 Scores on a scale
Standard Error 0.007
|
0.010 Scores on a scale
Standard Error 0.007
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
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.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5%
Any serious TEAE
|
7 Participants
|
—
|
|
Part B: Number of Participants Reporting Serious Treatment Emergent Adverse Events (Serious TEAEs) and Non-serious TEAEs > 5%
Any non-serious TEAE > 5%
|
94 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: 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, direct bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase and creatine phosphokinase.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Chemistry Parameters
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: Open-label Analysis Set
Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, potential of Hydrogen (pH), specific gravity, ketones, glucose.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: Open-label Analysis Set.
Twelve-lead ECGs were performed after participants has been recumbent for at least 5 minutes.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
|
0 Participants
|
—
|
PRIMARY outcome
Timeframe: Week 48 to Week 127Population: 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=249 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part B: Number of Participants With Clinically Significant Changes in Physical Examinations
|
0 Participants
|
—
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 48Population: Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
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.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=120 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=125 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Change From Baseline in Quality of Life in Neurologic Disorders Upper Extremity (Neuro-QoL UE) Scale at Week 48
|
-2.10 Scores on a scale
Standard Deviation 3.82
|
-1.51 Scores on a scale
Standard Deviation 3.68
|
SECONDARY outcome
Timeframe: At Week 48Population: Full Analysis Set.
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.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Very much worse
|
0 Participants
|
0 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Data missing
|
5 Participants
|
4 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Much worse
|
10 Participants
|
12 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Very much improved
|
1 Participants
|
2 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Much improved
|
7 Participants
|
5 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Minimally improved
|
28 Participants
|
24 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
No change
|
43 Participants
|
47 Participants
|
|
Part A: Number of Participants With Response to Patient's Global Impression of Change (PGIC) at Week 48
Minimally worse
|
36 Participants
|
36 Participants
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 48Population: Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
The whole-body longitudinal composite muscle fat infiltration (MFI) of predefined B muscles is measured by musculoskeletal (MSK) magnetic resonance imaging (MRI). MFI quantifies the extent of fat replacement in muscle tissue, which is a key marker of disease progression in facioscapulohumeral muscular dystrophy (FSHD). The B muscles are a prespecified subset of muscles that are most relevant to FSHD progression. A decrease or smaller increase in MFI indicates slower disease progression or a potential treatment benefit. Change from Baseline was calculated as the post-treatment value minus the value at Baseline.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=114 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=113 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Change From Baseline in Whole Body (WB) Longitudinal Composite Muscle Fat Infiltration (MFI) of B Muscles at Week 48
|
0.405 Percent
Standard Deviation 0.893
|
0.551 Percent
Standard Deviation 0.771
|
SECONDARY outcome
Timeframe: Baseline (Day 1) and at Week 48Population: Full Analysis Set. Only those participants with data available at specified timepoints has been presented.
Average shoulder abductor strength was assessed using hand-held dynamometry (HHD). Bilateral strength measurements were acquired from both upper limbs, with the average calculated for each participant. The relative change from baseline was expressed as a percentage. This evaluated the effect of losmapimod, relative to placebo, on muscle strength in individuals diagnosed with facioscapulohumeral muscular dystrophy (FSHD). Standardized procedures and equipment were employed across all study sites for strength testing, and trained personnel conducted all measurements to ensure consistency. Baseline is the last non-missing evaluation prior to first dose of study drug. Relative change from Baseline = 100 x (Post-baseline value - Baseline value) / (Baseline value).
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=124 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=125 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Relative Change From Baseline in Average Shoulder Abductor Strength by Hand-held Quantitative Dynamometry at Week 48
|
17.38 Percent
Standard Deviation 52.17
|
16.87 Percent
Standard Deviation 56.81
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Analysis Set comprises all participants who received any study drug in the placebo-controlled treatment period.
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.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants Serious TEAEs and TEAEs
Any non-serious TEAE
|
122 Participants
|
112 Participants
|
|
Part A: Number of Participants Serious TEAEs and TEAEs
Any serious TEAE
|
5 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Analysis Set.
Blood samples were collected for the analysis of clinical chemistry parameters including Glucose, sodium, potassium, calcium, inorganic phosphate, total protein, albumin, blood urea nitrogen, creatinine, total bilirubin, direct bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma-glutamyltransferase and creatine phosphokinase
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Clinical Chemistry Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Hematology Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Analysis Set
Urine samples were collected for the analysis of urinalysis parameters: Leucocytes, blood, nitrite, protein, urobilinogen, bilirubin, potential of Hydrogen (pH), specific gravity, ketones, glucose.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Urinalysis
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Vital Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety Analysis Set.
Twelve-lead ECGs was performed after participants has been recumbent for at least 5 minutes.
Outcome measures
| Measure |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Parameters
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: Up to Week 48Population: Safety 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 |
Part A: Losmapimod 15 Milligrams (mg)
n=130 Participants
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo
n=130 Participants
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
|---|---|---|
|
Part A: Number of Participants With Clinically Significant Changes in Physical Examinations
|
0 Participants
|
0 Participants
|
Adverse Events
Part A: Placebo-controlled Treatment Period: Losmapimod
Serious events: 5 serious events
Other events: 122 other events
Deaths: 0 deaths
Part A: Placebo-controlled Treatment Period: Placebo
Serious events: 8 serious events
Other events: 112 other events
Deaths: 1 deaths
Part B: Open Label Treatment Period: Losmapimod
Serious events: 7 serious events
Other events: 94 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Part A: Placebo-controlled Treatment Period: Losmapimod
n=130 participants at risk
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo-controlled Treatment Period: Placebo
n=130 participants at risk
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
Part B: Open Label Treatment Period: Losmapimod
n=249 participants at risk
Participants who completed Part A rolled over into Part B and received Losmapimod 15 mg orally twice daily (BID) with food.
|
|---|---|---|---|
|
Cardiac disorders
Atrial fibrillation
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Cardiac disorders
Extrasystoles
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Cardiac disorders
Supraventricular tachycardia
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Eye disorders
Retinal detachment
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Gastrointestinal disorders
Colitis ischaemic
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
Appendicitis
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.5%
2/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
COVID-19
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
Diverticulitis
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
Pneumonia
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
Urosepsis
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Accidental exposure to product by child
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Ankle fracture
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Peroneal nerve injury
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Post ablation syndrome
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Investigations
Blood creatinine increased
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Musculoskeletal and connective tissue disorders
Lumbar spinal stenosis
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Small cell lung cancer metastatic
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Nervous system disorders
Lumbar radiculopathy
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.00%
0/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
Other adverse events
| Measure |
Part A: Placebo-controlled Treatment Period: Losmapimod
n=130 participants at risk
Participants received Losmapimod 15 mg orally twice daily (BID) with food for 48 weeks.
|
Part A: Placebo-controlled Treatment Period: Placebo
n=130 participants at risk
Participants received matching placebo orally twice daily (BID) with food for 48 weeks.
|
Part B: Open Label Treatment Period: Losmapimod
n=249 participants at risk
Participants who completed Part A rolled over into Part B and received Losmapimod 15 mg orally twice daily (BID) with food.
|
|---|---|---|---|
|
Infections and infestations
Influenza
|
4.6%
6/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
6.2%
8/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
2.0%
5/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
Nasopharyngitis
|
23.1%
30/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
22.3%
29/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
7.6%
19/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.6%
6/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
9.2%
12/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
2.8%
7/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
4.6%
6/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
8.5%
11/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.80%
2/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Gastrointestinal disorders
Diarrhoea
|
6.9%
9/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
8.5%
11/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
2.0%
5/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Gastrointestinal disorders
Nausea
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.6%
4/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Nervous system disorders
Dizziness
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.5%
2/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.6%
4/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Nervous system disorders
Headache
|
12.3%
16/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
12.3%
16/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
4.4%
11/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Injury, poisoning and procedural complications
Fall
|
16.9%
22/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
17.7%
23/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
8.0%
20/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Skin and subcutaneous tissue disorders
Rash
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.2%
3/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
General disorders
Fatigue
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
5.4%
7/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
1.6%
4/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
General disorders
Influenza like illness
|
6.2%
8/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.77%
1/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
0.40%
1/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
|
Infections and infestations
COVID-19
|
12.3%
16/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
10.0%
13/130 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
3.6%
9/249 • Part A: Up to 48 Weeks; Part B (OLE Period): Up to Week 127
Serious TEAE and TEAE \> 5% has been presented for Safety Analysis Set in Part A and Open-label Analysis Set in Part B. Safety Analysis Set comprises of all participants who received any study drug in the placebo-controlled treatment period. Open-Label Analysis Set comprises of all participants who received at least 1 dose of losmapimod in Part B.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER