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An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia

StatusActive, Not Recruiting
PhasePhase 2
Started
View on ClinicalTrials.gov ↗

Record History

  1. 2 versions Re-verified since Jan 7, 2025, no change to tracked fieldsv18-v19
  2. Primary completion date: Sep 2026 to May 2038
    • Study completion date: Dec 2026 to May 2038
    v17
  3. 3 versions Re-verified since Dec 9, 2022, no change to tracked fieldsv14-v16
  4. Enrollment target: estimated 70 to confirmed 73
    • Interventions: Active BMN 111: Daily subcutaneous injection of 15 ug/kg of BMN 111 (Drug) to Active BMN 111: Subcutaneous injection of recommended dose of BMN 111 based on weight-band dosing once daily. (Drug)
    v13
  5. Trial status: Enrolling by Invitation to Active, Not Recruitingv12
Show 10 earlier versionsHide 10 earlier versions
  1. 3 versions Re-verified since Dec 18, 2020, no change to tracked fieldsv9-v11
  2. Study sites: 13 to 16v8
  3. Study sites: 10 to 13v7
  4. Study sites: 9 to 10v6
  5. Study sites: 5 to 9v5
  6. Study sites: 2 to 5v4
  7. Study sites: 1 to 2v3
  8. Trial status: Not Yet Recruiting to Enrolling by Invitation
    • Study sites: 0 to 1
    v2
  1. 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  • Stopped: an ongoing trial was terminated, suspended or withdrawn.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 Phase 2, open-label multi-center long-term extension study, with approximately 70 subjects, to evaluate the safety and efficacy of BMN111 in children with Achondroplasia until subjects reach near-adult final height. Eligible subjects will have completed 1 year of BMN111 or placebo treatment in the 111-206 study and once enrolled in the 111-208 extension study will receive a daily dose of BMN111 by subcutaneous injection according to their age as determined by 111-206.
Trial Details
NCT Number NCT03989947
Lead Sponsor BioMarin Pharmaceutical
Conditions
(from sponsor)		 Achondroplasia
Related terms Achondroplasia, Bone Diseases, Dwarfism, Musculoskeletal Diseases
Enrollment 73 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov