NCT05312697

Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta

A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 2 (actual)
• Sponsor: Ultragenyx Pharmaceutical Inc · Industry
• Sex: All
• Age: 19 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI).

Detailed description

UX143-CL203 is a long-term extension study in adults with OI who participated in the ASTEROID study (also referred to as MBPS205) \[NCT03118570\]. The UX143-CL203 study comprises Observation, Retreatment, and Extension Periods. There is no intervention during the Observation Period. During the single-arm Retreatment Period, participants receive open-label setrusumab once a month (QM) for 12 months. Following the Retreatment Period, participants enter an Extension Period in which they will continue treatment with open-label setrusumab at different dosing frequencies.

Conditions

• Osteogenesis Imperfecta

Interventions

Type	Name	Description
BIOLOGICAL	Setrusumab	A fully human anti-sclerostin monoclonal antibody (mAb)

Timeline

• Start date: 2022-04-28
• Primary completion: 2022-07-07
• Completion: 2022-07-07
• First posted: 2022-04-05
• Last updated: 2025-07-23
• Results posted: 2025-07-23

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study