NCT03583697

A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia

A Phase 2 Randomized, Double-Blind, Placebo-Controlled Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia, Age 0 to < 60 Months

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 75 (actual)
• Sponsor: BioMarin Pharmaceutical · Industry
• Sex: All
• Age: 59 Months
• Healthy volunteers: Not accepted

Summary

Study 111-206 is a Phase 2 randomized, double-blind, placebo-controlled clinical trial of BMN 111 in infants and young children with a diagnosis of achondroplasia.

Conditions

• Achondroplasia

Interventions

Type	Name	Description
DRUG	BMN 111	Subcutaneous injection of 15 μg/kg/day and/or 30 μg/kg/day of BMN 111 daily, subject to adjustment per protocol
DRUG	Placebo	Subcutaneous injection of 15 μg/kg of placebo daily, Subject to adjustment per protocol

Timeline

• Start date: 2018-06-13
• Primary completion: 2022-01-26
• Completion: 2022-01-26
• First posted: 2018-07-11
• Last updated: 2024-06-13
• Results posted: 2024-06-13

Locations

16 sites across 4 countries: United States, Australia, Japan, United Kingdom

Regulatory

• FDA-regulated drug study