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

StatusCompleted
PhasePhase 2
Started

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Record History

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  1. Primary endpoint(s) modified Show 6 more changesShow less
    • Trial completed
    • Primary and study completion dates changed from estimate of Sep 2026 to Sep 7, 2026
    • Secondary endpoints: 9 to 13
    • Site details revised at 8 of 51 sites
    • Eligibility criteria shortened, about 2 words
    • Study description expanded, about 4 words
  2. Site details revised at 1 of 51 sitesv43
  3. 2 versions Re-verified since Apr 28, 2026, no change to tracked fieldsv41-v42
  4. Site details revised at 1 of 51 sitesv40
  5. Enrollment target: 175 to 244v39
Show 37 earlier versionsHide 37 earlier versions
  1. Start date: Jul 6, 2022 to Nov 10, 2022
    • Primary and study completion dates: Aug 2026 to Sep 2026
    v38
  2. Re-verified, no change to tracked fieldsv37
  3. Site details revised at 1 of 51 sitesv36
  4. Site details revised at 1 of 51 sitesv35
  5. 4 versions Re-verified since Mar 31, 2025, no change to tracked fieldsv31-v34
  6. Enrollment target: estimated 170 to confirmed 175
    • Primary and study completion dates: Jun 2026 to Aug 2026
    v30
  7. Trial status: Recruiting to Active, Not Recruiting
    • Site details revised at 51 of 51 sites
    v29
  8. Re-verified, no change to tracked fieldsv28
  9. Site details revised at 3 of 51 sitesv27
  10. Site details revised at 4 of 51 sitesv26
  11. Site details revised at 8 of 51 sitesv25
  12. Site details revised at 3 of 51 sitesv24
  13. Study sites: 31 to 51v23
  14. Study sites: 28 to 31v22
  15. Study sites: 21 to 28v21
  16. Primary endpoints revised (4)
    • Study sites: 19 to 21
    • Interventions: EDG-5506 10 mg (Drug), EDG-5506 12.5 mg (Drug), EDG-5506 5 mg (Drug), Placebo (Drug) to Placebo (Drug), Sevasemten 10 mg (Drug), Sevasemten 12.5 mg (Drug), Sevasemten 5 mg (Drug)
    • Study description revised
    v20
  17. Re-verified, no change to tracked fieldsv19
  18. Study sites: 17 to 19v18
  19. Study sites: 16 to 17v17
  20. Re-verified, no change to tracked fieldsv16
  21. Enrollment target: 66 to 170v15 Show 9 more changesShow less
    • Primary and study completion dates: Dec 2023 to Jun 2026
    • Primary endpoints: 3 to 4
    • Study sites: 15 to 16
    • Interventions: EDG-5506 Dose 1 (Drug), EDG-5506 Dose 2 (Drug), EDG-5506 Dose 3 (Drug), EDG-5506 Dose 4 (Drug), EDG-5506 Dose 5 (Drug), Placebo (Drug) to EDG-5506 10 mg (Drug), EDG-5506 12.5 mg (Drug), EDG-5506 5 mg (Drug), Placebo (Drug)
    • Eligibility criteria shortened, about 28 words
    • Secondary endpoints: 6 to 9
    • Study description expanded, about 75 words
    • Collaborators: 1 to 3
    • Study title expanded, about 1 word
  22. Study sites: 14 to 15v14
  23. Eligibility criteria shortened, about 6 wordsv13
  24. Study sites: 13 to 14v12
  25. Study sites: 12 to 13v11
  26. Study sites: 11 to 12v10
  27. Study sites: 9 to 11v9
  28. Site details revised at 1 of 9 sitesv8
  29. Study sites: 8 to 9v7
  30. Study sites: 6 to 8v6
  31. Study sites: 4 to 6v5
  32. Study sites: 1 to 4v4
  33. Trial status: Not Yet Recruiting to Recruitingv3 Show 8 more changesShow less
    • Enrollment target: 54 to 66
    • Study sites: 0 to 1
    • Start date changed from estimate of Apr 2022 to Jul 6, 2022
    • Interventions: EDG-5506 Dose 1 (Drug), EDG-5506 Dose 2 (Drug), EDG-5506 Dose 3 (Drug), Placebo (Drug) to EDG-5506 Dose 1 (Drug), EDG-5506 Dose 2 (Drug), EDG-5506 Dose 3 (Drug), EDG-5506 Dose 4 (Drug), EDG-5506 Dose 5 (Drug), Placebo (Drug)
    • Eligibility criteria expanded, about 10 words
    • Study arms: 4 to 5
    • Study description shortened, about 4 words
    • Study title expanded, about 1 word
  34. Primary endpoints revised (3)
    • Eligibility criteria revised
    • Secondary endpoints revised (6)
    • Study description expanded, about 2 words
    v2
  1. Study First Submitted
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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 175 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.
Trial Details
NCT Number NCT05291091
Lead Sponsor Edgewise Therapeutics, Inc.
Collaborators: Medpace, Inc., ImagingNMD, SYSNAV
Conditions
(from sponsor)		 Becker Muscular Dystrophy
Related terms Muscular Dystrophy, Duchenne
Enrollment 244 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov