Setrusumab vs Placebo for Osteogenesis Imperfecta

Phase 2/3 Active not recruiting 183 enrolled Ultragenyx Pharmaceutical Inc Mereo BioPharma · collab

RandomizedSequentialQuadruple-blindTreatment

Summary

The primary objectives of the study are to identify a setrusumab dosing strategy in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in fracture rate.

Timeline

Start: 2022-02-21
Primary completion: 2025-10-20
Completion: 2027-04

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

release “NCT05125809 ) demonstrating that, as of a May 24, 2024 data cut-off date, treatment with setrusumab (UX143) continued to significantly reduce incidence of fractures” reads as met primary endpoint ultragenyx.com ↗

release “Neither study achieved its primary endpoint of reduction in annualized clinical fracture rate compared to placebo (ORBIT) or bisphosphonates (COSMIC)” reads as missed primary endpoint mereobiopharma.com ↗

Publications

Bartosik M, Windels O, von Brackel FN, Amling M, Oheim R. Romosozumab in postmenopausal women with classical Osteogenesis imperfecta. Arch Osteoporos. 2026 Jul 18;21(1):100. doi: 10.1007/s11657-026-01744-3.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setrusumab	Monoclonal antibody	—	Intravenous