NCT02724228

A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH)

A Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children With Achondroplasia

• Status: Active Not Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: BioMarin Pharmaceutical · Industry
• Sex: All
• Age: 7 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase 2, Open-Label, Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of BMN 111 in Children with Achondroplasia. The primary objective is to evaluate the long-term safety and tolerability of daily SC injections of BMN 111 in children with ACH who have completed two years of treatment in the 111-202 study.

Conditions

• Achondroplasia

Interventions

Type	Name	Description
DRUG	BMN 111	BMN 111 will be administered subcutaneously daily.

Timeline

• Start date: 2016-01-26
• Primary completion: 2027-12-01
• Completion: 2028-02-01
• First posted: 2016-03-31
• Last updated: 2026-03-13

Locations

9 sites across 4 countries: United States, Australia, France, United Kingdom