A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 (ASTEROID)
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ClinicalTrials.gov Identifier: NCT03118570 |
Recruitment Status :
Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : May 4, 2020
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Osteogenesis Imperfecta, Type I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV | Drug: BPS804 | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Double-blind, Dose-finding Study, incorporating an open-label substudy |
Masking: | Double (Participant, Investigator) |
Masking Description: | Sponsor will be masked until the primary analysis of the study except for open-label substudy treatment arm. The study site pharmacist will be unmasked to treatment allocation throughout. Study treatment will be monitored by a separate unmasked monitoring team. |
Primary Purpose: | Treatment |
Official Title: | Protocol Title: A Phase 2b, Multicentre, Multinational, Double-blind, Dose-finding Study, Incorporating an Open Label Substudy, in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With Setrusumab (BPS804). |
Actual Study Start Date : | September 11, 2017 |
Actual Primary Completion Date : | September 27, 2019 |
Estimated Study Completion Date : | October 31, 2020 |

Arm | Intervention/treatment |
---|---|
Experimental: BPS804 Dose 1
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
Other Name: setrusumab |
Experimental: BPS804 Dose 2
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
Other Name: setrusumab |
Experimental: BPS804 Dose 3
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
Other Name: setrusumab |
Experimental: BPS804 Dose 4
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
Other Name: setrusumab |
- Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computated Tomography
- Change in bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computated Tomography
- Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computative Tomography
- Change in bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]High Resolution Peripheral Quantitative Computative Tomography
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]OI-QOL-A
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]SF-12
- Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]EQ5D
- Changes in lumbar bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
- Changes in whole body bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
- Changes in proximal femur bone mineral density (t-score) [ Time Frame: 6 and 12 months ]Dual-energy x-ray absorptiometry
- Serum concentrations of BPS804, anti-BPS804 antibodies and BPS804 neutralising antibodies [ Time Frame: 12 months ]Serum concentrations of BPS804, anti-BPS804 antibodies and BPS804 neutralising antibodies

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Patients with a clinical diagnosis of OI Type I, III or IV with a confirmed defect in the COL1A1/COL1A2 genes, as confirmed by genetic testing
- One or more fractures in the past 5 years
- Capable of giving signed consent
Exclusion Criteria:
- History of skeletal malignancies or other bone diseases (other than OI)
- 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, denosomab or other anabolic/antiresorbative medications within 6 months of randomisation

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03118570
United States, Alabama | |
Mereo Investigator Site | |
Birmingham, Alabama, United States, 35294 | |
United States, Florida | |
Mereo Investigator Site | |
Jacksonville, Florida, United States, 32207 | |
United States, Maryland | |
Mereo Investigator Site | |
Baltimore, Maryland, United States, 21287 | |
United States, Massachusetts | |
Mereo Investigator Site | |
Boston, Massachusetts, United States, 012115 | |
United States, Minnesota | |
Mereo Investigator Site | |
Saint Paul, Minnesota, United States, 55101 | |
United States, Missouri | |
Mereo Investigator Site | |
Saint Louis, Missouri, United States, 63110 | |
United States, New Mexico | |
Mereo Investigator Site | |
Albuquerque, New Mexico, United States, 87106 | |
United States, Ohio | |
Mereo Investigator Site | |
Cincinnati, Ohio, United States, 45229 | |
United States, Oregon | |
Mereo Investigator Site | |
Portland, Oregon, United States, 97239 | |
United States, Pennsylvania | |
Mereo Investigator Site | |
Pittsburgh, Pennsylvania, United States, 15225 | |
United States, Tennessee | |
Mereo Investigator Site | |
Nashville, Tennessee, United States, 37232 | |
United States, Texas | |
Mereo Investigator Site | |
Houston, Texas, United States, 77030 | |
Canada, Ontario | |
Mereo Investigator Site | |
Toronto, Ontario, Canada | |
Canada, Quebec | |
Mereo Investigator Site | |
Montreal, Quebec, Canada | |
Mereo Investigator Site | |
Quebec City, Quebec, Canada | |
Denmark | |
Mereo Investigator Site | |
Aarhus, Denmark | |
Mereo Investigator Site | |
Odense, Denmark | |
France | |
Mereo Investigator Site | |
Paris, Paris Cedex 14, France | |
Mereo Investigator Site | |
Lyon, France | |
Mereo Investigator Site | |
Paris, France | |
United Kingdom | |
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 |
Study Chair: | Jay Shapiro, Prof. | Johns Hopkins University | |
Principal Investigator: | Francis Glorieux, Prof. | Shriner's Hospital for Children, Montreal | |
Principal Investigator: | Kassim Javaid, Assoc. Prof. | Nuffield Orthopaedic Centre, University of Oxford Hospitals Foundation Trust |
Responsible Party: | Mereo BioPharma |
ClinicalTrials.gov Identifier: | NCT03118570 |
Other Study ID Numbers: |
MBPS205 2016-005096-27 ( EudraCT Number ) |
First Posted: | April 18, 2017 Key Record Dates |
Last Update Posted: | May 4, 2020 |
Last Verified: | May 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Osteogenesis Imperfecta Brittle Bone Disease |
Osteogenesis Imperfecta Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Collagen Diseases Connective Tissue Diseases |