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A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia

NCT03197766 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 121

Last updated 2022-03-02

Study results available
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Summary

The intent and design of this Phase 3 study is to assess BMN 111 as a therapeutic option for the treatment of children with Achondroplasia.

Conditions

Interventions

DRUG

BMN 111

Subcutaneous injection of 15 μg/kg of BMN 111 daily

DRUG

Placebo

Subcutaneous injection of 15 μg/kg of placebo daily

Sponsors & Collaborators

Principal Investigators

  • Medical Director, MD · BioMarin Pharmaceutical

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-12-12
Primary Completion
2019-10-30
Completion
2019-10-30

Countries

  • United States
  • Australia
  • Germany
  • Japan
  • Spain
  • Turkey (Türkiye)
  • United Kingdom

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03197766 on ClinicalTrials.gov