SAR439459 for Osteogenesis Imperfecta

Recruiting at20 trial locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: Sanofi

Trial Summary

What is the purpose of this trial?

This trial tests SAR439459, a medicine that blocks certain proteins, in adults with Osteogenesis Imperfecta. The goal is to see if it can safely improve bone strength and density over several months.

Research Team

Clinical Sciences & Operations

Principal Investigator

Sanofi

Eligibility Criteria

Adults with Osteogenesis Imperfecta (OI) types I or IV, who've had at least one bone fracture in the past decade or two since turning 18. They must weigh over 30 kg and not be pregnant, breastfeeding, or donating sperm. Participants need a documented genetic variant in COL1A1/COL1A2 and must consent to the study.

Inclusion Criteria

I have Type I or IV osteogenesis imperfecta with a known genetic cause.

You have given your written permission to participate in the study.

I am using birth control, not pregnant, not breastfeeding, and if male, not donating sperm.

Treatment Details

Interventions

• SAR439459 (Monoclonal Antibodies)

Trial Overview The trial is testing SAR439459, an antibody targeting TGFβ, given once via IV to see if it's safe and how it affects people with OI. It includes checking for side effects, how the body processes the drug (PK), its impact on bones (PD), bone density through DXA scans, and blood biomarkers over six months.

Participant Groups

Group I: SAR439459 Experimental Treatment 1 Intervention

Participants will receive a single dose of SAR439459

Group II: Placebo Placebo Group 1 Intervention

Participants will receive a single dose of placebo

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University