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Rare Disease Research, LLC | Atlanta, GA

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Open-Label Extension of EDG-5506 in Participants With Becker Muscular Dystrophy (MESA)

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Edgewise Therapeutics

Status and phase

Invitation-only
Phase 2

Conditions

Becker Muscular Dystrophy

Treatments

Drug: Sevasemten

Study type

Interventional

Funder types

Industry

Identifiers

NCT06066580
EDG-5506-203

Details and patient eligibility

About

EDG-5506-203 MESA is an open-label extension study to assess the long-term effect of sevasemten (EDG-5506) on safety, biomarkers, and functional measures in adults and adolescents with Becker muscular dystrophy

Full description

This is an open-label, treatment extension study to evaluate the safety, tolerability, and durability of effect in long-term dosing of sevasemten. EDG-5506-203 MESA will provide continued access to sevasemten treatment to participants with Becker muscular dystrophy who were previously enrolled in EDG-5506-002 ARCH, completed EDG-5506-201 CANYON and GRAND CANYON, or completed EDG-5506-202 DUNE.

Enrollment

200 estimated patients

Sex

Male

Volunteers

No Healthy Volunteers

Inclusion criteria

  1. Participation in EDG-5506-002 ARCH, EDG-5506-201 CANYON and GRAND CANYON, or EDG-5506-202 DUNE. Participants are eligible if they complete the respective prior study visits as follows:
  • EDG-5506-002 ARCH: Complete the final study Visit 27 [Month 24]; or, completion of the ET visit prior to Visit 27 [Month 24]
  • EDG-5506-201 CANYON and GRAND CANYON: Complete the final study visit (Cohorts 1, 2, 4, and 5: Visit 12 [Month 12]; Cohort 6: Visit 11 [Month 18])
  • EDG-5506-202 DUNE: Complete at least 36 weeks of open-label treatment

Exclusion criteria

  1. Any clinically significant changes during or following participation in EDG-5506-002, EDG-5506-201, or EDG-5506-202 that would affect the potential safety of the participant to receive sevasemten.
  2. Receipt of an investigational drug other than sevasemten within 30 days or 5 half-lives (whichever is longer) of dosing in the present study.
  3. Receipt of oral corticosteroids for the treatment of BMD in the previous 6 months.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

200 participants in 1 patient group

Treatment
Experimental group
Description:
Drug: Sevasemten
Treatment:
Drug: Sevasemten

Trial contacts and locations

16

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Data sourced from clinicaltrials.gov

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