Single Ascending Dose Study of SAR439459 in Adults With Osteogenesis Imperfecta (OI)
NCT ID: NCT05231668
Last Updated: 2025-09-11
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE1
16 participants
INTERVENTIONAL
2022-08-25
2024-11-12
Brief Summary
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Participants will receive a single IV dose of SAR439459 with safety, pharmacokinetic (PK), and pharmacodynamic (PD) assessments over 24 weeks.
There will be up to 3 dose cohorts. In addition to safety, tolerability, and PK assessments, bone mineral density (BMD) will be evaluated by dual-energy Xray absorptimetry (DXA) scan and a series of blood biomarkers will be monitored to document pharmacodynamic effects of the single dose of SAR439459.
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Detailed Description
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* Up to 5 weeks from initiation of screening to dose administration
* Treatment on Day 1
* Follow-up and observation of safety and PD for 24 weeks
* Final study visit at Week 24
Conditions
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Study Design
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RANDOMIZED
SEQUENTIAL
TREATMENT
TRIPLE
Study Groups
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SAR439459
Participants will receive a single dose of SAR439459
SAR439459
Powder for solution for infusion; IV infusion
Placebo
Participants will receive a single dose of placebo
Placebo
Solution for infusion; IV infusion
Interventions
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SAR439459
Powder for solution for infusion; IV infusion
Placebo
Solution for infusion; IV infusion
Eligibility Criteria
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Inclusion Criteria
* Participants who have experienced at least 1 bone fracture in the past 10 years OR 2 or more (≥2) fractures since the age of 18.
* Body weight ≥30.0 kg.
* Contraception for sexually active male participants or female patient; not pregnant or breastfeeding; no sperm donating for male participant.
* Signed written informed assent/consent.
Exclusion Criteria
* History of moderate (25-40°) to severe (\>40°) scoliosis assessed as Cobb angle (unless scoliosis does not impact assessment of bone mineral density in the lumbar vertebrae in the opinion of the investigator).
* Postmenopausal women who:
* Are within 5 years of the onset of menopause (for example less than 5 years from their last menstruation or post-hysterectomy), however if the person has been on hormone replacement therapy for more than 1 year prior to enrollment, then they are eligible regardless of time from onset of menopause. The person must be willing to continue hormone replacement therapy throughout the study duration. OR
* Were previously on hormone replacement therapy but have stopped within the past 5 years.
* History of treatment with denosumab, anti-sclerostin antibody, parathyroid hormone, bisphosphonates, or any other experimental therapy for OI within 6 months prior to any study baseline assessment.
* Known bleeding disorder.
* History of significant bleeding event that required hospitalization, surgery, or a blood transfusion that was possibly associated with increased bleeding tendency.
* Any major surgery within the last 28 days prior to investigational medicinal product (IMP) administration.
* Elective surgery or invasive procedure anticipated within 6 months after the IMP administration.
* Therapeutic doses of anticoagulants or antiplatelet agents (eg, 1 mg/kg bid of enoxaparin, 300 mg of aspirin daily, and 75 mg of clopidogrel daily or equivalent) within 7 days prior to the IMP administration.
* Any known central nervous system (CNS) or intraocular lesion that has a risk of bleeding.
* Prior history of skin cancers including melanoma, squamous cell carcinoma, or basal cell carcinoma.
* Clinically significant cardiac valvular disorder or symptomatic heart failure.
* Vitamin D (25-hydoxyvitamin D) \<15 ng/dL; rescreening will be allowed after supplementation.
The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
18 Years
65 Years
ALL
No
Sponsors
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Sanofi
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Sciences & Operations
Role: STUDY_DIRECTOR
Sanofi
Locations
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UCLA Health_Site Number: 8400006
Los Angeles, California, United States
Yale University - Site Number:8400007
New Haven, Connecticut, United States
Indiana University School of Medicine_Site Number: 8400002
Indianapolis, Indiana, United States
Kennedy Krieger Institute_Site number 8400004
Baltimore, Maryland, United States
Cincinnati Children's Hospital Medical Center Site Number : 8400010
Cincinnati, Ohio, United States
Vanderbilt University Site Number : 8400011
Nashville, Tennessee, United States
Baylor College of Medicine - Site Number:8400003
Houston, Texas, United States
Westmead Hospital_Site Number :0360003
Westmead, New South Wales, Australia
Department of Medicine/ School of Clinical Sciences at Monash Health Monash University_246 Clayton Road_Site Number :0360002
Clayton, Victoria, Australia
Bone Research and Education Centre_Site Number :1240003
Oakville, Ontario, Canada
Toronto general Hospital_Site Number :1240002
Toronto, , Canada
Hopital Edouard Herriot _Site Number :2500002
Lyon, , France
Hopital Lariboisiere_Site Number :2500001
Paris, , France
Countries
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Related Links
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SAD17378 Plain Language Results Summary
Other Identifiers
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U1111-1269-6569
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-511369-12-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
2021-004914-21
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
SAD17378
Identifier Type: -
Identifier Source: org_study_id
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