A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
NCT ID: NCT03118570
Last Updated: 2023-07-05
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
112 participants
INTERVENTIONAL
2017-09-11
2020-11-12
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
setrusumab
Intravenous infusion
Calcium
tablets
Vitamin D
capsules
zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
setrusumab
Intravenous infusion
Calcium
tablets
Vitamin D
capsules
zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
setrusumab
Intravenous infusion
Calcium
tablets
Vitamin D
capsules
zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
setrusumab
Intravenous infusion
Calcium
tablets
Vitamin D
capsules
zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Calcium
tablets
Vitamin D
capsules
Interventions
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setrusumab
Intravenous infusion
Calcium
tablets
Vitamin D
capsules
zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* One or more fractures in the past 5 years
* Capable of giving signed consent
Exclusion Criteria
* History of neural foraminal stenosis (except if due to scoliosis)
* History of myocardial infarction, angina pectoris, ischaemic stroke or transient ischaemic attack
* History of endocrine or thyroid/parathyroid conditions that could affect bone metabolism
* Treatment with bisphosphonates within 3 months of randomisation
* Treatment with teraparatide, denosumab or other anabolic/anti-reabsorptive medications within 6 months of randomisation
18 Years
75 Years
ALL
No
Sponsors
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Mereo BioPharma
INDUSTRY
Ultragenyx Pharmaceutical Inc
INDUSTRY
Responsible Party
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Principal Investigators
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Medical Director
Role: STUDY_DIRECTOR
Mereo BioPharma
Locations
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Mereo Investigator Site
Birmingham, Alabama, United States
Mereo Investigator Site
Jacksonville, Florida, United States
Mereo Investigator Site
Baltimore, Maryland, United States
Mereo Investigator Site
Boston, Massachusetts, United States
Mereo Investigator Site
Saint Paul, Minnesota, United States
Mereo Investigator Site
St Louis, Missouri, United States
Mereo Investigator Site
Albuquerque, New Mexico, United States
Mereo Investigator Site
Cincinnati, Ohio, United States
Mereo Investigator Site
Portland, Oregon, United States
Mereo Investigator Site
Pittsburgh, Pennsylvania, United States
Mereo Investigator Site
Nashville, Tennessee, United States
Mereo Investigator Site
Houston, Texas, United States
Mereo Investigator Site
Toronto, Ontario, Canada
Mereo Investigator Site
Montreal, Quebec, Canada
Mereo Investigator Site
Québec, Quebec, Canada
Mereo Investigator Site
Aarhus, , Denmark
Mereo Investigator Site
Odense, , Denmark
Mereo Investigator Site
Paris, Paris Cedex 14, France
Mereo Investigator Site
Lyon, , France
Mereo Investigator Site
Paris, , France
Mereo Investigator Site
Cambridge, Cambridgeshire, United Kingdom
Mereo Investigator Site
Newcastle upon Tyne, Newcastle, United Kingdom
Mereo Investigator Site
Oxford, Oxfordshire, United Kingdom
Mereo Investigator Site
Bristol, , United Kingdom
Mereo Investigator Site
London, , United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Other Identifiers
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2016-005096-27
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MBPS205
Identifier Type: -
Identifier Source: org_study_id
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