A Phase 3, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Evaluate the Efficacy and Safety of Vosoritide in Children with Hypochondroplasia

Status

Recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-513129-22-00

Acronym

111-303

Enrollment

Registered

2024-09-16

Start date

2024-12-17

Completion date

Unknown

Last updated

2025-09-15

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypochondroplasia

Brief summary

Change from baseline in AGV at Week 52

Detailed description

Change from baseline in standing height at Week 52 versus placebo, Change from baseline in height Z-score at Week 52 versus placebo

Interventions

DRUGVoxzogo 0.56 mg powder and solvent for solution for injection

DRUGpowder and solvent for solution for injection

DRUGVoxzogo 1.2 mg powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
Change from baseline in AGV at Week 52	—

Secondary

Measure	Time frame
Change from baseline in standing height at Week 52 versus placebo, Change from baseline in height Z-score at Week 52 versus placebo	—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026