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Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)
Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)

NCT05291091

Active Not RecruitingPhase 2

Sponsor: Edgewise Therapeutics, Inc.

Conditions: Becker Muscular Dystrophy

Interventions: Sevasemten 10 mg, Sevasemten 5 mg, Sevasemten 12.5 mg, Placebo

Countries: United States, Australia, Belgium, Denmark, France, Germany, Israel, Italy

A study of sevasemten (EDG-5506) in Becker muscular dystrophy (known as CANYON) and pivotal cohort (known as GRAND CANYON). The EDG-5506-201 CANYON study was expanded to include an additional 120 adult participants in a cohort called GRAND CANYON, that is a multicenter, randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of sevasemten in adults with Becker. CANYON and GRAND CANYON are fully enrolled.

Eligibility overview

Sex: MALE

Age: 12 Years to 50 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
The CANYON Study including the adolescent cohorts are fully enrolled.

GRAND CANYON eligibility is listed below.

Key Inclusion Criteria:

1. Adults (aged 18 to 50 years, inclusive) with a documented dystrophin mutation and phenotype consistent with Becker muscular dystrophy, and history of being ambulatory beyond 16 years of age without steroids; history of being ambulatory beyond 18 years of age with steroids.
2. Able to complete the 100-meter timed test in \< 200 seconds with or without use of mobility aid devices.
3. Able to perform the North Star Ambulatory Assessment scale and achieve a score of 5 to 32, inclusive.

Key Exclusion Criteria:

1. Medical history or clinically significant physical examination/laboratory result that, in the opinion of the investigator, would render the participant unsuitable for the study. This includes contraindications to magnetic resonance imaging such as non-compatible implanted medical devices or severe claustrophobia.
2. Cardiac echocardiogram ejection fraction \< 40%
3. Forced vital capacity predicted \<60% or using daytime ventilatory support
4. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.
5. Receipt of an investigational drug within 30 days or 5 half-lives (whichever is longer) of the screening visit in the present study.
Locations (51)
  • Little Rock, Arkansas, United States
  • La Jolla, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • Palo Alto, California, United States
  • Sacramento, California, United States
  • Aurora, Colorado, United States
  • Gainesville, Florida, United States
  • Atlanta, Georgia, United States
  • Chicago, Illinois, United States
  • Indianapolis, Indiana, United States
  • Iowa City, Iowa, United States
  • Kansas City, Kansas, United States
  • Baltimore, Maryland, United States
  • Worcester, Massachusetts, United States
  • Minneapolis, Minnesota, United States
  • St Louis, Missouri, United States
  • Rochester, New York, United States
  • Hillsborough, North Carolina, United States
  • Cincinnati, Ohio, United States
  • Columbus, Ohio, United States
  • Philadelphia, Pennsylvania, United States
  • Pittsburgh, Pennsylvania, United States
  • Austin, Texas, United States
  • Denton, Texas, United States
  • Richmond, Virginia, United States
  • Fitzroy, Australia
  • Ghent, Belgium
  • Leuven, Belgium
  • Liège, Belgium
  • + 21 more on CT.gov