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Monoclonal Antibodies

SAR439459 for Osteogenesis Imperfecta

Phase 1
Recruiting
Research Sponsored by Sanofi
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Participants who are clinically categorized as Type I or IV osteogenesis imperfecta with a previously documented pathogenic genetic variant in COL1A1 or COL1A2.
Body weight ≥30.0 kg.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up from baseline to week 24
Awards & highlights

Summary

This trial will test the safety of a new drug, SAR439459, in adults with OI. The study will also look at how well the drug works and what effects it has on the body.

Who is the study for?
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.Check my eligibility
What is being tested?
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.See study design
What are the potential side effects?
Potential side effects are not specified but will be monitored throughout the trial. These may include typical reactions to monoclonal antibodies such as infusion-related reactions, immune system changes affecting organs' function, allergic responses or other unforeseen issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have Type I or IV osteogenesis imperfecta with a known genetic cause.
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My body weight is at least 30 kg.
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I have had at least one bone fracture in the last 10 years or two since turning 18.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~from baseline to week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of participants with adverse events (AEs)/treatment-emergent adverse events (TEAEs)
Secondary outcome measures
Assessment of PK parameters: area under the curve (AUC)
Assessment of PK parameters: maximum serum concentration observed (Cmax)
Assessment of PK parameters: time to reach maximum concentration observed (tmax)
+2 more

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SAR439459Experimental Treatment1 Intervention
Participants will receive a single dose of SAR439459
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive a single dose of placebo

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor
2,173 Previous Clinical Trials
3,516,466 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
866 Previous Clinical Trials
2,020,185 Total Patients Enrolled

Media Library

SAR439459 (Monoclonal Antibodies) Clinical Trial Eligibility Overview. Trial Name: NCT05231668 — Phase 1
Osteogenesis Imperfecta Research Study Groups: SAR439459, Placebo
Osteogenesis Imperfecta Clinical Trial 2023: SAR439459 Highlights & Side Effects. Trial Name: NCT05231668 — Phase 1
SAR439459 (Monoclonal Antibodies) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05231668 — Phase 1
~8 spots leftby Jun 2025