Clinical Trials Logo
  1. Home
  2. Becker Muscular Dystrophy
  3. NCT05160415

A Study of EDG-5506 in Adult Males With Becker Muscular Dystrophy — ARCH  

Becker Muscular Dystrophy Clinical Trial

Official title:
A Phase 1b, Open-label Study of the Safety and Pharmacokinetics of EDG-5506 in Adults With Becker Muscular Dystrophy

Clinical Trial Summary

The ARCH study is an open-label, single-center, Phase 1b study of sevasemtem (EDG-5506) to assess the safety and pharmacokinetics (PK) of sevasemten in adults with Becker muscular dystrophy (BMD). Sevasemten is an investigational product intended to protect and improve function of dystrophic muscle fibers.

Clinical Trial Description

This open-label study will evaluate the safety, tolerability, and pharmacokinetics (PK) of sevasemten in participants with BMD who completed the first-in-human study, EDG-5506-001, as well as additional (treatment-naïve) participants from outside the EDG-5506-001 study to meet the target sample size. All participants will receive sevasemten. On-site visits will occur approximately monthly for the first 12 months, followed by every 3 months to assess safety and measures of function. This study will have a 24 month treatment period, followed by a 4 week follow-up period. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05160415
Study type Interventional
Source Edgewise Therapeutics, Inc.
Contact
Status Completed
Phase Phase 1
Start date December 28, 2021
Completion date March 1, 2024
View Details
See also
  Status Clinical Trial Phase
Terminated NCT01168908 - Revatio for Heart Disease in Duchenne Muscular Dystrophy and Becker Muscular Dystrophy Phase 2
Recruiting NCT01484678 - Magnetic Resonance Imaging and Biomarkers for Muscular Dystrophy
Completed NCT02147639 - Effects of Sodium Nitrate on Blood Flow in Becker Muscular Dystrophy Phase 2/Phase 3
Completed NCT02847975 - Sodium Nitrate to Improve Blood Flow Phase 1
Recruiting NCT02069756 - The Duchenne Registry
Completed NCT04585464 - A Study to Assess Safety, Tolerability, and PK of EDG-5506 in Healthy Volunteers and Becker Muscular Dystrophy Adults Phase 1
Recruiting NCT04668716 - Brain Involvement in Dystrophinopathies Part 2
Completed NCT03236662 - (-)- Epicatechin Becker Muscular Dystrophy Phase 2
Completed NCT01350154 - Effect of Modulating the nNOS System on Cardiac, Muscular and Cognitive Function in Becker Muscular Dystrophy Patients Phase 2
Enrolling by invitation NCT06066580 - Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy Phase 2
Not yet recruiting NCT06363526 - Effectiveness of 5-week Digital Respiratory Practice in a Group of Children With Duchenne Muscular Dystrophy and Becker Muscular Dystrophy. N/A
Recruiting NCT05409079 - Schulze Muscular Dystrophy Ability Clinical Study N/A
Completed NCT01856868 - Use of (-)-Epicatechin in the Treatment of Becker Muscular Dystrophy (Pilot Study) Phase 1/Phase 2
Completed NCT01557400 - Study of Ataluren for Previously Treated Participants With Nonsense Mutation Duchenne/Becker Muscular Dystrophy (nmDBMD) in Europe, Israel, Australia, and Canada Phase 3
Recruiting NCT02109692 - Evaluation of Muscle miRNA as Biomarkers in Dystrophinopathies N/A
Recruiting NCT03057002 - UTSW HP [13-C] Pyruvate Injection in HCM
Recruiting NCT04583917 - Brain Involvement in Dystrophinopathies Part 1
Withdrawn NCT03076814 - Functional Muscle Ischemia With Tadalafil Treatment in Becker Muscular Dystrophy N/A
Completed NCT02207283 - PDE5 Inhibition to Alleviate Functional Muscle Ischemia in Becker Muscular Dystrophy Phase 4
Completed NCT00873782 - Safety Study of Transvenous Limb Perfusion in Human Muscular Dystrophy Phase 1