A Phase 3 Global, Randomized, Double-Blind, Placebo-Controlled, 48-Week, Parallel-Group Study of the Efficacy and Safety of Losmapimod in Treating Patients With Facioscapulohumeral Muscular Dystrophy (FSHD) (REACH)

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-512737-33-00

Acronym

1821-FSH-301

Enrollment

144

Registered

2024-08-06

Start date

2022-09-30

Completion date

2024-10-28

Last updated

2024-08-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Facioscapulohumeral Muscular Dystrophy (FSHD)

Brief summary

Part A: Change from baseline in average total RSA Q1-Q5 with 500 g wrist weight at Week 48, where average is applied over both arms Part B: Safety and tolerability of long-term treatment with losmapimod, based on the assessment of AEs, clinical laboratory tests, ECGs, vital signs, and physical examinations

Detailed description

Part A: 1. PGIC at Week 48 2. Change from baseline in WB longitudinal composite MFI of B muscles at Week 48 3. Relative change from baseline in average shoulder abductor strength by hand-held quantitative dynamometry at Week 48 4. Change from baseline in Neuro-QoL UE at Week 48, 5. Safety and tolerability, based on the assessment of AEs, clinical laboratory tests, ECGs, vital signs and physical examinations. Part B: No secondary endpoints

Interventions

DRUGPL1 - Placebo to match losmapimod tablets are tablets for oral administration and visually match the active losmapimod tablets

DRUG15 mg.

DRUGLosmapimod

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Part A: Change from baseline in average total RSA Q1-Q5 with 500 g wrist weight at Week 48, where average is applied over both arms Part B: Safety and tolerability of long-term treatment with losmapimod, based on the assessment of AEs, clinical laboratory tests, ECGs, vital signs, and physical examinations	—

Secondary

Measure	Time frame
Part A: 1. PGIC at Week 48 2. Change from baseline in WB longitudinal composite MFI of B muscles at Week 48 3. Relative change from baseline in average shoulder abductor strength by hand-held quantitative dynamometry at Week 48 4. Change from baseline in Neuro-QoL UE at Week 48, 5. Safety and tolerability, based on the assessment of AEs, clinical laboratory tests, ECGs, vital signs and physical examinations. Part B: No secondary endpoints	—

Measure

Time frame

—

Countries

Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026