Trial Outcomes & Findings for Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension (NCT NCT04004000)

Last Updated: 2025-12-02

Results Overview

An AE is any untoward medical occurrence in a clinical study participant, temporally associated with the use of a study intervention, whether or not considered related to the study intervention. A TEAE is an AE that begins on or after the first dose of study drug and before the stop of study drug + 7 days or begins before the first dose of study drug and worsens on or after the first dose of study drug and before the stop of study drug + 7 days. A Serious adverse event (SAE) is any untoward medical occurrence that, at any dose results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing hospitalization, results in persistent disability/incapacity, is a congenital anomaly/birth defect or any other situation according to medical or scientific judgment.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

14 participants

Primary outcome timeframe

Up to 68 Weeks

Results posted on

2025-12-02

Participant Flow

This was a single-center, open-label pilot study that investigated the safety, tolerability, pharmacokinetic (PK), and target engagement during long-term dosing with losmapimod tablets in adult participants with facioscapulohumeral muscular dystrophy 1 (FSHD1). The study comprised of a main study and an extension phase. A total of 14 participants were enrolled.

Participants were administered 15 milligrams (mg) losmapimod orally twice-daily (BID) for approximately 1 year during the main study and had the option to roll over into the extension study and continued to receive the treatment. The Sponsor decided to terminate the extension phase because the primary endpoint of Phase 3 REACH (NCT05397470) was not achieved.

Participant milestones

Participant milestones
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Main Study Phase (Up to 52 Weeks) STARTED	14
Main Study Phase (Up to 52 Weeks) COMPLETED	14
Main Study Phase (Up to 52 Weeks) NOT COMPLETED	0
Extension Phase (Up to 68 Weeks) STARTED	12
Extension Phase (Up to 68 Weeks) COMPLETED	0
Extension Phase (Up to 68 Weeks) NOT COMPLETED	12

Reasons for withdrawal

Reasons for withdrawal
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Extension Phase (Up to 68 Weeks) Sponsor terminated OLE as REACH (NCT05397470) Phase 3 study in FSHD did not meet primary endpoint.	12

Baseline Characteristics

Evaluation of Safety, Tolerability, and Changes in Biomarker and Clinical Outcome Assessments of Losmapimod for FSHD1 With Extension

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Age, Continuous	45.7 years STANDARD_DEVIATION 11.12 • n=121 Participants
Sex: Female, Male Female	3 Participants n=121 Participants
Sex: Female, Male Male	11 Participants n=121 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=121 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	14 Participants n=121 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=121 Participants
Race (NIH/OMB) Asian	0 Participants n=121 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=121 Participants
Race (NIH/OMB) Black or African American	1 Participants n=121 Participants
Race (NIH/OMB) White	13 Participants n=121 Participants
Race (NIH/OMB) More than one race	0 Participants n=121 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=121 Participants

PRIMARY outcome

Timeframe: Up to 68 Weeks

Population: Safety Analysis Set.

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Any TEAE	14 Participants
Number of Participants Reporting Treatment Emergent Adverse Events (TEAEs) and Serious TEAEs Any serious TEAE	2 Participants

PRIMARY outcome

Timeframe: Up to 68 Weeks

Population: Safety 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, uric acid, total bilirubin, alkaline phosphatase, aspartate aminotransferase, alanine aminotransferase, gamma glutamyl transferase, lactate dehydrogenase and creatine phosphokinase.

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Number of Participants With Clinically Significant Changes in Chemistry Parameters	0 Participants

PRIMARY outcome

Timeframe: Up to 68 Weeks

Population: 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

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Number of Participants With Clinically Significant Changes in Hematology Parameters	0 Participants

PRIMARY outcome

Timeframe: Up to 68 Weeks

Population: Safety Analysis Set

Blood samples were collected for the analysis of Serum coagulation parameters: International normalized ratio, prothrombin time, activated partial thromboplastin time and fibrinogen.

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Number of Participants With Clinically Significant Changes in Serum Coagulation Parameters	0 Participants

SECONDARY outcome

Timeframe: Baseline and at Week 44

Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.

Phosphorylated HSP27 in peripheral whole blood with ex-vivo sorbitol stimulation and in skeletal muscle (without sorbitol stimulation) was measured at specified time points. The pre-treatment value was considered as Baseline for change from Baseline calculations. The geometric mean for fold percent change from Baseline (and 95% confidence interval) in pHSP27/total HSP27 was calculated. Percent change from baseline = 100\*(exp(mean of change from baseline on the log-transformed scale) - 1).

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=11 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Percent Change From Baseline in the Ratio of Phosphorylated HSP27 (pHSP27) /Total HSP27 in Sorbitol-stimulated Whole Blood	-48.3 Percent change Interval -55.4 to -40.1

SECONDARY outcome

Timeframe: Baseline and at Week 8

Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.

Phosphorylated HSP27 in skeletal muscle (without sorbitol stimulation) was measured at specified time points. The pre-treatment value was considered as Baseline for change from Baseline calculations. The geometric mean for fold percent change from Baseline (and 95% confidence interval) in pHSP27/total HSP27 was calculated. Percent change from baseline = 100\*(exp(mean of change from baseline on the log-transformed scale) - 1).

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=2 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Percent Change From Baseline in Ratio of pHSP27/Total HSP27 in Muscle	33.9 Percent change Interval -78.3 to 726.5

SECONDARY outcome

Timeframe: Post-dose at Baseline, Week 4, Week 8, Week 20, Week 32, Week 44, and Week 56

Population: Safety Analysis Set. Only those participants with data available at specified timepoints has been presented.

Blood samples were collected to measure the plasma concentration of losmapimod at specified timepoints.

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=12 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Plasma Concentration of Losmapimod Week 44	75.029 Nanograms per milliliter Geometric Coefficient of Variation 0.316
Plasma Concentration of Losmapimod Week 56	66.268 Nanograms per milliliter Geometric Coefficient of Variation 0.367
Plasma Concentration of Losmapimod Baseline	58.923 Nanograms per milliliter Geometric Coefficient of Variation 0.488
Plasma Concentration of Losmapimod Week 4	92.737 Nanograms per milliliter Geometric Coefficient of Variation 0.220
Plasma Concentration of Losmapimod Week 8	83.006 Nanograms per milliliter Geometric Coefficient of Variation 0.356
Plasma Concentration of Losmapimod Week 20	80.889 Nanograms per milliliter Geometric Coefficient of Variation 0.315
Plasma Concentration of Losmapimod Week 32	82.261 Nanograms per milliliter Geometric Coefficient of Variation 0.275

SECONDARY outcome

Timeframe: Post dose at Baseline, Week 4, Week 8 and Week 44

Population: Safety Analysis Set. Only those participants with data available at specified time points has been presented.

Muscle biopsies were collected to measure the concentration of losmapimod at specified timepoints.

Outcome measures

Outcome measures
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=6 Participants Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Muscle Concentration of Losmapimod Baseline	0.215 Nanograms per milliliter Geometric Coefficient of Variation 0.348
Muscle Concentration of Losmapimod Week 4	84.456 Nanograms per milliliter Geometric Coefficient of Variation 0.198
Muscle Concentration of Losmapimod Week 8	77.904 Nanograms per milliliter Geometric Coefficient of Variation 0.134
Muscle Concentration of Losmapimod Week 44	73.193 Nanograms per milliliter Geometric Coefficient of Variation 0.199

Adverse Events

Losmapimod 15 Milligrams (mg) Twice Daily (BID)

Serious events: 2 serious events

Other events: 14 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 participants at risk Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Infections and infestations Pneumonia	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Interstitial lung disease	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.

Other adverse events

Other adverse events
Measure	Losmapimod 15 Milligrams (mg) Twice Daily (BID) n=14 participants at risk Participants were administered Losmapimod 15 mg twice-daily (BID) orally for approximately one year and then rolled over to extension phase to receive Losmapimod at the same dose until 90 days after commercial drug is available post regulatory approval or study termination.
Gastrointestinal disorders Diarrhoea	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Dry mouth	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Frequent bowel movements	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Mouth ulceration	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Nausea	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Vomiting	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
General disorders Chills	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
General disorders Fatigue	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
General disorders Feeling cold	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
General disorders Influenza like illness	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
General disorders Non-cardiac chest pain	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Immune system disorders Seasonal allergy	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations COVID-19	71.4% 10/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Cystitis	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Fungal skin infection	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Herpes zoster	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Influenza	50.0% 7/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Localised infection	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Nasopharyngitis	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Onychomycosis	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Oral herpes	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Oral infection	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Otitis media	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Skin bacterial infection	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Infections and infestations Tinea pedis	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Animal bite	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Burns second degree	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Contusion	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Epicondylitis	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Face injury	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Fall	57.1% 8/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Foreign body	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Heat stroke	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Inflammation of wound	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Ligament rupture	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Limb injury	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Mouth injury	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Muscle strain	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Nerve injury	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Post procedural haematoma	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Procedural pain	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Road traffic accident	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Skin abrasion	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Skin laceration	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Sunburn	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Tendon injury	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Injury, poisoning and procedural complications Tendon rupture	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Investigations Alanine aminotransferase increased	42.9% 6/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Investigations Aspartate aminotransferase increased	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Investigations Blood bilirubin increased	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Investigations Blood pressure diastolic increased	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Investigations Gamma-glutamyltransferase increased	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Arthralgia	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Back pain	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Bursitis	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Groin pain	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Joint swelling	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Muscle fatigue	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Muscle spasms	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Muscular weakness	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Musculoskeletal stiffness	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Myalgia	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Musculoskeletal and connective tissue disorders Pain in extremity	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Nervous system disorders Dizziness	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Nervous system disorders Headache	28.6% 4/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Nervous system disorders Hypoaesthesia	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Nervous system disorders Neuralgia	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Nervous system disorders Paraesthesia	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Psychiatric disorders Agitation	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Psychiatric disorders Depressed mood	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Reproductive system and breast disorders Amenorrhoea	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Reproductive system and breast disorders Menopausal symptoms	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Reproductive system and breast disorders Penile rash	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Dyspnoea exertional	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Nasal congestion	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Nasal crusting	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Nasal dryness	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Respiratory, thoracic and mediastinal disorders Painful respiration	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Acne	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Dry Skin	42.9% 6/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Eczema	42.9% 6/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Eczema asteatotic	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Hyperkeratosis	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Ingrowing nail	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Nail discolouration	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Pruritus	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Rash pruritic	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Skin hyperpigmentation	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Skin ulcer	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Toxic skin eruption	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Skin and subcutaneous tissue disorders Urticaria	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Vascular disorders Haematoma	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Vascular disorders Hypertension	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Cardiac disorders Palpitations	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Ear and labyrinth disorders Middle ear effusion	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Ear and labyrinth disorders Tinnitus	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Eye disorders Dry eye	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Eye disorders Eczema eyelids	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Eye disorders Eye irritation	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Eye disorders Lacrimation increased	14.3% 2/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Abdominal pain upper	21.4% 3/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.
Gastrointestinal disorders Colitis microscopic	7.1% 1/14 • Up to 68 Weeks TEAEs and serious TEAEs were collected in Safety population which included all participants who received study drug.

Additional Information

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Fulcrum Therapeutics

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Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place