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Study to Evaluate the Efficacy and Safety of BMN 333 Versus Vosoritide in Children With Achondroplasia

Study acronym: ASPEN
StatusRecruiting
PhasePhase 2/3
Started
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Record History

See every version on ClinicalTrials.gov ↗

  1. Trial sites expanded: 25 → 28 locations
    • Eligibility criteria expanded, about 10 words
    • Study description expanded, about 2 words
  2. Trial sites expanded: 19 → 25 locationsv7
  3. Study sites: 18 to 19v6
  4. Trial sites expanded: 10 → 18 locations
    • Start date changed from estimate of Apr 2026 to Apr 20, 2026
    v5
  5. Trial sites expanded: 4 → 10 locationsv4
  6. Study sites: 2 to 4v3
  7. Recruitment opened
    • Start date: Feb 2026 to Apr 2026
    • Study sites: 0 to 2
    • Study title shortened, about 3 words
    v2
  8. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • 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.
This is a multicenter, multinational, randomized, active-controlled, operationally seamless Phase 2/3 study of BMN 333 in treatment-naïve pediatric participants with achondroplasia (ACH). The study consists of a Phase 2 part and a Phase 3 part.
Trial Details
NCT Number NCT07441876
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Genetic Diseases, Inborn, Musculoskeletal Diseases, Osteochondrodysplasias
Enrollment 160 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov