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Clinical Trial Summary

The primary objectives of the study are to identify a dose(s) of setrusumab based on safety and pharmacodynamic (PD) effects in participants with OI and to evaluate the effect of setrusumab vs placebo on reduction in total fracture rate.

Clinical Trial Description

Participants in Cohort A will be randomized 1:1:1 to receive setrusumab (low or high dose) or placebo. Participants will continue receiving their assigned dose of setrusumab until the phase 3 dose is determined. After the phase 3 dose(s) of setrusumab has been selected, all Cohort A participants will be included in the Phase 3 period of the study in a blinded manner. Participants who received setrusumab during the Phase 2 period will transition to the selected dose(s) of setrusumab, and participants in the placebo group will continue receiving placebo in the Phase 3 period. Participants in Cohort B will be randomized 2:1 to receive setrusumab (at the dose[s] selected in the primary analysis of Phase 2 period) or placebo. Treatment assignments will remain blinded throughout the study. Participants will transition to an open-label Treatment Extension Period after the Phase 3 primary analysis is complete, or once a participant has completed 24 months of treatment in the double-blind period, whichever is sooner. ;

Study Design

Related Conditions & MeSH terms

NCT number NCT05125809
Study type Interventional
Source Ultragenyx Pharmaceutical Inc
Contact Patient Contact: Trial Recruitment
Phone 1-888-756-8657
Email [email protected]
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 2021
Completion date March 2026

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