Safety and Efficacy of KER-065 in Participants With Duchenne Muscular Dystrophy

Sponsor
Keros Therapeutics, Inc.
Study ID
NCT07704099
Phase
PHASE2
Status
Not Yet Recruiting

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Conditions

Eligibility Criteria

Sex
MALE
Age
9 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • KER-065 — DRUG
    KER-065 will be administered subcutaneously (SC)

Study Details

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (PK), pharmacodynamics (PD), and efficacy of KER-065 administered to adult and pediatric ambulatory and nonambulatory male participants with Duchenne Muscular Dystrophy (DMD) on stable background therapy.

Key Dates

First listed
Jul 15, 2026
Start date
Sep 14, 2026
Status verified
Jul 2026
Primary completion
Jul 17, 2029
Completion
Aug 14, 2029

Study Design

Enrollment
36 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Cohort A1 (Late Ambulatory)
    Participants will receive stable corticosteroid (CS) along with KER-065.
  • Experimental: Cohort A2 (Late Ambulatory)
    Participants will receive stable CS, exon skipper along with KER-065.
  • Experimental: Cohort N1 (Nonambulatory)
    Participants will receive stable CS along with KER-065.

Primary Outcome Measure

Number of participants with treatment-emergent adverse events (TEAEs and serious adverse events (SAEs) [ Time Frame: Up to approximately 3 years ]

Central Contacts

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