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NCT05291091 · ClinicalTrials.gov registry record · Phase 2

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

A Phase 2 study of Becker Muscular Dystrophy, sponsored by Edgewise Therapeutics.

Active
Registry status
Phase 2
Development phase
244
Enrollment target
20
Study locations

NCT05291091 is a Phase 2 study of Becker Muscular Dystrophy that is active but no longer recruiting, run by Edgewise Therapeutics. The registered enrollment target is 244 participants, below the 1,376-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (82% lower). The trial reports 20 study locations across 16 states.

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The verdict

NCT05291091, a Phase 2 study of Becker Muscular Dystrophy, is active but no longer recruiting, sponsored by Edgewise Therapeutics.

ACTIVE NOT RECRUITING
Registry status
Phase 2
Development phase
244 participants
Enrollment target
20
Study locations

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 Studied

Becker Muscular Dystrophy

Interventions

  • DRUG Placebo
  • DRUG Sevasemten 10 mg
  • DRUG Sevasemten 5 mg
  • DRUG Sevasemten 12.5 mg

Study Locations (20)

California

  • UC San Diego - La Jolla
  • UCLA Medical Center - Los Angeles
  • UC Irvine Medical Center - Orange
  • Stanford Neuroscience Health Center - Palo Alto
  • UC Davis Medical Center - Sacramento

Arkansas

  • Arkansas Children's Hospital - Little Rock

Colorado

  • UC Denver - Aurora

Florida

  • University of Florida - Gainesville

Georgia

  • Rare Disease Research - Atlanta

Illinois

  • Northwestern University - Chicago

Indiana

  • Indiana University School of Medicine - Indianapolis

Iowa

  • University of Iowa - Iowa City

Trial Details

FieldValue
Enrollment Target 244 participants
Start Date 2022-11-10
Est. Completion 2026-09
Phase Phase 2

Sponsor

Edgewise Therapeutics

15 total trials

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Full Details on ClinicalTrials.gov ↗

What the Registry Record Tells You About NCT05291091

The ClinicalTrials.gov registry entry for NCT05291091 describes a study currently listed as active not recruiting, categorized as Phase 2. The registered enrollment target is 244 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 1,376-participant average among 12 other Becker Muscular Dystrophy trials with a reported enrollment target (82% lower). The listed sponsor is Edgewise Therapeutics, which has 15 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Becker Muscular Dystrophy appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.

NCT05291091 reports 20 study locations spanning 16 distinct geographic areas - top geographies include California, Arkansas, Colorado.

Frequently Asked Questions

What is clinical trial NCT05291091 about?

NCT05291091 is a clinical study titled "Phase 2 Study of EDG-5506 in Becker Muscular Dystrophy (GRAND CANYON)". 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, pla...

What is the current status of trial NCT05291091?

This trial is currently active not recruiting. It is a Phase 2 study. The enrollment target is 244 participants. The study started on 2022-11-10. Estimated completion is 2026-09.

What conditions does trial NCT05291091 study?

This clinical trial studies the following conditions: Becker Muscular Dystrophy.

What interventions are being tested in trial NCT05291091?

The interventions under investigation include: Placebo (DRUG), Sevasemten 10 mg (DRUG), Sevasemten 5 mg (DRUG), Sevasemten 12.5 mg (DRUG).

Who is sponsoring clinical trial NCT05291091?

This trial is sponsored by Edgewise Therapeutics, which has 15 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT05291091 being conducted?

This trial has 20 study locations across Arkansas, California, Colorado, Florida, Georgia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.