- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05312697
Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
A Phase 2b, Multicenter, Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 2
Contacts and Locations
Study Locations
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New Mexico
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Albuquerque, New Mexico, United States, 87106
- New Mexico Clinical Research & Osteoporosis Center
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Males or females who participated in the Phase 2b ASTEROID study
- Females of childbearing potential must consent to use highly effective contraception during the Observation, Retreatment, and Extension Periods through 2 months after the last dose of setrusumab and agree not to become pregnant
Exclusion Criteria:
- Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the participant at increased risk for adverse effects
- Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results
- Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study
- Not willing or able to discontinue bisphosphonates 6 months prior to the Retreatment Screening Visit
Once enrolled in UX143-CL203, individuals who meet any of the following exclusion criteria will not be eligible to participate in the Retreatment Period:
- Concurrent participation in any study that is examining the safety and efficacy of any investigational product or investigational medical device that alters bone health during the Retreatment and Extension Periods, per discretion of the Investigator in consultation with the Medical Monitor.
- Calcium levels outside the normal range at the Retreatment Screening Visit. If the participant's calcium level is not within the normal range, decision to retest should be made in conjunction with the Medical Monitor
- Glomerular filtration rate (GFR) ≤ 29 mL/min at the Retreatment Screening Visit. If the participant's GFR is ≤ 29 mL/min, decision to retest should be made in conjunction with the Medical Monitor
- History of skeletal malignancies or bone metastases at any time
- History of neural foraminal stenosis (except if due to scoliosis)
- History of myocardial infarction, angina pectoris, ischemic stroke or transient ischemic attack (Investigators should consider whether the potential benefits of treatment outweigh the potential risks in patients with other cardiovascular risk factors such as hypertension, hyperlipidemia, familial hyperlipidemia, family history of premature ischemic cardiovascular disease, smoking, diabetes mellitus, and metabolic syndrome.)
- History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism, hypo-/hyperthyroidism, Paget's disease, abnormal thyroid function or thyroid disease or other endocrine disorders or conditions that could affect bone metabolism eg, Stage IV/V renal disease
- A history of rickets or osteomalacia or any skeletal condition (other than OI) leading to long-bone deformities and/or increased risk of fractures
- Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of such abuse as indicated by the laboratory results during the screening/baseline assessments
- Documented history of significant psychiatric or medical disorder that would prevent the participant complying with the requirements of the protocol or would make it unsafe for the participant to participate in the study as judged by the investigator
- Current/previously reported allergy to the study drug or any of its excipients or the class of drug under investigation
- History of external radiation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Sequential Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Setrusumab QM -->Setrusumab QM
During Retreatment Period: Setrusumab will be administered via intravenous (IV) infusion once a month (QM) for 12 months. During Extension Period: Setrusumab will be administered via IV infusion QM for at least 12 months or until commercially available. |
A fully human anti-sclerostin monoclonal antibody (mAb)
Other Names:
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Experimental: Setrusumab QM --> Setrusumab TBD
During Retreatment Period: Setrusumab will be administered via IV infusion QM for 12 months. During Extension Period: Setrusumab will be administered via IV infusion at a dose frequency to be determined (TBD) for at least 12 months or until commercially available. |
A fully human anti-sclerostin monoclonal antibody (mAb)
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage Change From Retreatment Baseline in Lumbar Spine Bone Mineral Density (BMD) Measured by Dual-Energy X-Ray Absorptiometry (DXA) After 12 Months of Setrusumab
Time Frame: Retreatment Baseline, Month 12
|
Retreatment Baseline, Month 12
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Percentage Change From Retreatment Baseline in Total Hip BMD Measured by DXA at Month 12 of the Retreatment Period
Time Frame: Retreatment Baseline, Month 12
|
Retreatment Baseline, Month 12
|
Annualized New Fracture Rate as Confirmed by Radiograph During the Retreatment Period
Time Frame: Up to Month 12
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Up to Month 12
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Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Director: Medical Director, Ultragenyx Pharmaceutical Inc
Publications and helpful links
Helpful Links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UX143-CL203
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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Shriners Hospitals for ChildrenNovartisCompleted
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Baylor College of MedicineRecruiting
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Clinical Trials on Setrusumab
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Ultragenyx Pharmaceutical IncRecruitingOsteogenesis ImperfectaUnited States, Canada, Germany, France, Poland, Netherlands, Italy, Brazil
-
Ultragenyx Pharmaceutical IncMereo BioPharmaRecruitingOsteogenesis ImperfectaUnited States, Canada, Turkey, Argentina, Germany, Australia, Italy, Portugal, United Kingdom, Poland, France, Netherlands
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Ultragenyx Pharmaceutical IncMereo BioPharmaCompletedOsteogenesis Imperfecta Type III | Osteogenesis Imperfecta Type IV | Osteogenesis Imperfecta, Type IUnited States, Canada, Denmark, France, United Kingdom