A Phase 3, Open-Label, Long-Term Extension Study to Evaluate the Safety and Efficacy of Vosoritide in Children with Hypochondroplasia

Status

Not yet recruiting

Phases

Phase 3

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-517238-16-00

Acronym

111-308

Enrollment

Registered

2025-11-03

Start date

Unknown

Completion date

Unknown

Last updated

2025-11-13

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

Conditions

Hypochondroplasia

Brief summary

1. Incidence of treatment emergent adverse events over time until FAH, 2. Change from baseline in height Z-score yearly until FAH, 3. Change from baseline in height yearly until FAH

Detailed description

1. Change from baseline in height at Week 52 of Study 111-308, 2. Change from baseline in height Z-score at Week 52 of Study 111-308 Baseline is based on first dose of study drug (vosoritide or placebo) in the parent study (111-303 or 111 212).

Interventions

DRUGVoxzogo 0.56 mg powder and solvent for solution for injection

DRUGVoxzogo 1.2 mg powder and solvent for solution for injection

DRUGVoxzogo 0.4 mg powder and solvent for solution for injection

Eligibility

Sex/Gender

All

Age

0 Years to 17 Years

Design outcomes

Primary

Measure	Time frame
1. Incidence of treatment emergent adverse events over time until FAH, 2. Change from baseline in height Z-score yearly until FAH, 3. Change from baseline in height yearly until FAH	—

Secondary

Measure	Time frame
1. Change from baseline in height at Week 52 of Study 111-308, 2. Change from baseline in height Z-score at Week 52 of Study 111-308 Baseline is based on first dose of study drug (vosoritide or placebo) in the parent study (111-303 or 111 212).	—

Countries

France, Germany, Italy, Spain

Outcome results

None listed

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