CLINICAL TRIALS PROFILE FOR VOSORITIDE
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All Clinical Trials for vosoritide
| Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
|---|---|---|---|---|---|---|
| NCT02055157 ↗ | A Phase 2 Study of BMN 111 to Evaluate Safety, Tolerability, and Efficacy in Children With Achondroplasia | Completed | BioMarin Pharmaceutical | Phase 2 | 2014-01-13 | This is a Phase 2, open-label, sequential cohort dose-escalation study of BMN 111 in children with achondroplasia. The primary objective is to assess the safety and tolerability of daily BMN 111 administered to children with achondroplasia. |
| NCT02724228 ↗ | A Study to Evaluate Long-Term Safety, Tolerability, & Efficacy of BMN 111 in Children With Achondroplasia (ACH) | Active, not recruiting | BioMarin Pharmaceutical | Phase 2 | 2016-01-26 | 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. |
| NCT03197766 ↗ | A Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia | Completed | BioMarin Pharmaceutical | Phase 3 | 2016-12-12 | 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. |
| NCT03424018 ↗ | An Extension Study to Evaluate the Efficacy and Safety of BMN 111 in Children With Achondroplasia | Active, not recruiting | BioMarin Pharmaceutical | Phase 3 | 2017-12-12 | 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 |
| NCT03583697 ↗ | A Clinical Trial to Evaluate the Safety and Efficacy of BMN 111 in Infants and Young Children With Achondroplasia | Active, not recruiting | BioMarin Pharmaceutical | Phase 2 | 2018-05-23 | 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. |
| NCT03989947 ↗ | An Extension Study to Evaluate Safety and Efficacy of BMN 111 in Children With Achondroplasia | Enrolling by invitation | BioMarin Pharmaceutical | Phase 2 | 2019-06-12 | 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. |
| NCT04219007 ↗ | Vosoritide for Selected Genetic Causes of Short Stature | Recruiting | Andrew Dauber | Phase 2 | 2020-08-04 | Short stature can be caused by a number of genetic etiologies, many of which directly affect the growth plate. The FGFR3/CNP pathway is central to growth of the chondrocyte. The study team hypothesizes that patients with selected genetic causes of short stature that interact with this pathway will benefit from treatment with vosoritide, a CNP analog, a selective NPR-B agonist which directly targets the growth plate. This study will enroll patients with short stature in selected genetic categories and will follow them for a 6 month observation period to obtain a baseline growth velocity, safety profile and quality of life assessment. Patients will then be treated with vosoritide for 12 months and will be assessed for safety monitoring and improvement in height outcomes. |
| >Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
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