NCT05291091|Active Not RecruitingPhase 2DMCFDA Drug

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

A Phase 2 Randomized, Double-blind, Placebo-controlled Study to Evaluate the Effect of EDG-5506 on Safety, Biomarkers, Pharmacokinetics, and Functional Measures in Adults and Adolescents With Becker Muscular Dystrophy

Edgewise Therapeutics, Inc.ClinicalTrials.gov

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1 other identifier

EDG-5506-201

Study Type

interventional

Target

244

Locations

12 countries

Sites

Timeline

RegisteredMar 2022

StartedNov 2022

CompletionSep 2026

Brief 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.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

244

participants targeted

Target at P75+ for phase_2

Timeline

4mo left

Started Nov 2022

Typical duration for phase_2

Geographic Reach

12 countries

51 active sites

Status

active not recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

3.8 years study duration

Study Progress92%

Nov 2022Sep 2026

First Submitted

Initial submission to the registry

March 14, 2022

Completed

8 days until next milestone

First Posted

Study publicly available on registry

March 22, 2022

Completed

8 months until next milestone

Study Start

First participant enrolled

November 10, 2022

Completed

3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2026

Expected

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2026

Last Updated

May 4, 2026

Status Verified

April 1, 2026

Enrollment Period

3.8 years

First QC Date

March 14, 2022

Last Update Submit

April 28, 2026

Conditions

Becker Muscular Dystrophy

Keywords

Becker Muscular Dystrophy

Outcome Measures

Primary Outcomes (4)

Number of adverse events in those treated with sevasemten or placebo
All participants
12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6)
Severity of adverse events in those treated with sevasemten or placebo
All participants
12 months (CANYON Cohorts 1, 2, 4, 5), 18 months (GRAND CANYON Cohort 6)
Change from Baseline in serum Creatine Kinase
Adult participants
12 Months (CANYON Cohorts 1, 2)
Change from Baseline in the North Star Ambulatory Assessment scale
Adult participants
18 months (GRAND CANYON Cohort 6)

Secondary Outcomes (9)

Change from Baseline in the protein fast skeletal muscle Troponin I
12 months (CANYON Cohorts 1, 2), 18 months (GRAND CANYON Cohort 6)
Change from Baseline in the North Star Ambulatory Assessment scale
12 Months (CANYON Cohorts 1, 2)
Change from Baseline in the North Star Assessment for Limb-Girdle Type Muscular Dystrophies scale
12 Months (CANYON Cohorts 1, 2), 18 Months (GRAND CANYON Cohort 6)
Change from Baseline in the 10-meter walk/run test
12 Months (CANYON Cohorts 1, 2), 18 Months (GRAND CANYON Cohort 6)
Change from Baseline in 100-meter timed test
12 Months (CANYON Cohorts 1, 2), 18 Months (GRAND CANYON Cohort 6)
+4 more secondary outcomes