Clinical Trial

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

Active, Not Recruiting Phase 2
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Summary
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.
Protocol Amendment History 18 amendments
This ClinicalTrials.gov record has been amended 18 times since 2019-06-16; most recent amendment 2026-03-12.
Status change: Enrolling by Invitation → Active, Not Recruiting 2022-02-14
Status change: Not Yet Recruiting → Enrolling by Invitation 2019-07-08
Trial Details
NCT Number NCT03989947
Lead Sponsor BioMarin Pharmaceutical
Conditions Achondroplasia
Enrollment 73 participants
Start Date 2019-06-12
Primary Completion 2038-05 (estimated)
Study Completion 2038-05 (estimated)
Updated on ClinicalTrials.gov 2026-03-13