Trials / Active Not Recruiting
Active Not RecruitingNCT04554940
A Clinical Trial to Evaluate Safety of Vosoritide in At-risk Infants With Achondroplasia
A Randomized, Controlled, Open-label Clinical Trial With an Open-label Extension to Investigate the Safety of Vosoritide in Infants and Young Children With Achondroplasia at Risk of Requiring Cervicomedullary Decompression Surgery
- Status
- Active Not Recruiting
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 20 (actual)
- Sponsor
- BioMarin Pharmaceutical · Industry
- Sex
- All
- Age
- 0 Months – 12 Months
- Healthy volunteers
- Not accepted
Summary
Study 111-209 is a Phase 2 randomized, open-label clinical trial of BMN 111 in infants and young children with a diagnosis of Achondroplasia at a heightened risk of requiring cervicomedullary decompression surgery
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | vosoritide | Subcutaneous injection of recommended dose of BMN 111 based on weight-band dosing once daily. |
Timeline
- Start date
- 2020-10-10
- Primary completion
- 2027-12-01
- Completion
- 2027-12-01
- First posted
- 2020-09-18
- Last updated
- 2026-03-13
Locations
3 sites across 2 countries: Australia, United Kingdom
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT04554940. Inclusion in this directory is not an endorsement.