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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 up to 5 years
Summary
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.
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.
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.
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 belowSelect...
I have Type I or IV osteogenesis imperfecta with a known genetic cause.
Select...
My body weight is at least 30 kg.
Select...
I have had at least one bone fracture in the last 10 years or two since turning 18.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ up to 5 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
Treatment Details
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
SAR439459
2017
Completed Phase 1
~170
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Who is running the clinical trial?
SanofiLead Sponsor
2,195 Previous Clinical Trials
4,035,109 Total Patients Enrolled
Clinical Sciences & OperationsStudy DirectorSanofi
871 Previous Clinical Trials
2,020,932 Total Patients Enrolled
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Eligibility Criteria:
This trial includes the following eligibility 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.My body weight is at least 30 kg.I have had at least one bone fracture in the last 10 years or two since turning 18.
Research Study Groups:
This trial has the following groups:- Group 1: SAR439459
- Group 2: Placebo
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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