An Open-Label Extension Study to Assess the Long-term Effect of EDG-5506 on Safety, Biomarkers, and Functional Measures in Adults and Adolescents with Becker Muscular Dystrophy

Status

Recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-506231-15-00

Acronym

EDG-5506-203

Enrollment

Registered

2023-12-11

Start date

2024-02-22

Completion date

Unknown

Last updated

2025-10-15

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

Conditions

Becker Muscular Dystrophy

Brief summary

1. Incidence, frequency, and severity of AEs and SAEs in those treated with sevasemten

Detailed description

1. Incidence of treatment-emergent abnormal laboratory test results (clinical chemistry, hematology), 2. Change from Baseline in: − Safety labs − Vital Signs − ECG parameters − Cardiac function as assessed by an echocardiogram − Pulmonary function as assessed by FEV1, FVC

Interventions

DRUGEDG-5506

Eligibility

Sex/Gender

Male

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
1. Incidence, frequency, and severity of AEs and SAEs in those treated with sevasemten	—

Secondary

Measure	Time frame
1. Incidence of treatment-emergent abnormal laboratory test results (clinical chemistry, hematology), 2. Change from Baseline in: − Safety labs − Vital Signs − ECG parameters − Cardiac function as assessed by an echocardiogram − Pulmonary function as assessed by FEV1, FVC	—

Countries

Belgium, Denmark, France, Germany, Italy, Netherlands, Spain

Outcome results

None listed

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