A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

Phase 2 Completed 112 enrolled Ultragenyx Pharmaceutical Inc Mereo BioPharma · collab

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.

Timeline

Start: 2017-09-11
Primary completion: 2019-10-01
Completion: 2020-11-12

Publications

Glorieux FH, Langdahl B, Chapurlat R, De Beur SJ, Sutton VR, Poole KES, Dahir KM, Orwoll ES, Willie BM, Mikolajewicz N, Zimmermann E, Hosseinitabatabaei S, Ominsky MS, Saville C, Clancy J, MacKinnon A, Mistry A, Javaid MK. Setrusumab for the treatment of osteogenesis imperfecta: 12-month results from the phase 2b asteroid study. J Bone Miner Res. 2024 Sep 2;39(9):1215-1228. doi: 10.1093/jbmr/zjae112.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Setrusumab	Monoclonal antibody	2 mg/kg	Intravenous
Subject	Setrusumab	Monoclonal antibody	8 mg/kg	Intravenous
Subject	Setrusumab	Monoclonal antibody	20 mg/kg	Intravenous
Background	Zoledronic acid	Other / unclassified	—	—

A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804

Summary

Timeline

Publications

Drugs

Indications