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

NCT05291091 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 244

Last updated 2026-05-20

No results posted yet for this study

Summary

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.

Conditions

  • Becker Muscular Dystrophy

Interventions

DRUG

Sevasemten 10 mg

Sevasemten is administered orally once per day

DRUG

Sevasemten 5 mg

Sevasemten is administered orally once per day

DRUG

Sevasemten 12.5 mg

Sevasemten is administered orally once per day

DRUG

Placebo

Placebo is administered orally once per day

Sponsors & Collaborators

  • Medpace, Inc.

    collaborator INDUSTRY

  • ImagingNMD

    collaborator UNKNOWN

  • SYSNAV

    collaborator INDUSTRY

  • Edgewise Therapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • Joanne Donovan, MD, PhD · Edgewise Therapeutics, Inc.

  • Roxana D. Dreghici · Edgewise Therapeutics, Inc.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
SEQUENTIAL

Eligibility

Min Age
12 Years
Max Age
50 Years
Sex
MALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-10
Primary Completion
2026-09-30
Completion
2026-09-30
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Belgium
  • Denmark
  • France
  • Germany
  • Israel
  • Italy
  • Netherlands
  • New Zealand
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05291091 on ClinicalTrials.gov