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A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 (ASTEROID)
This study is currently recruiting participants.
Verified September 2017 by Mereo BioPharma
Sponsor:
Mereo BioPharma
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma
ClinicalTrials.gov Identifier:
NCT03118570
First received: April 3, 2017
Last updated: September 7, 2017
Last verified: September 2017
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Purpose
The purpose of this study is to select a suitable dose of BPS804 by comparing it with a dummy treatment and measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 1 year.
| Condition | Intervention | Phase |
|---|---|---|
| Osteogenesis Imperfecta, Type I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV | Drug: BPS804 Drug: Placebo IV Infusion 5% Dextrose | Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Intervention Model: Parallel Assignment Intervention Model Description: Placebo-controlled, Double-blind, Dose-finding Study Masking: Double (Participant, Investigator)Masking Description: Sponsor will be masked until the primary analysis of the study. 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: | A Phase 2b Study, Multicentre, Multinational, Placebo-controlled, Double-blind, Dose-finding Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 |
Resource links provided by NLM:
Genetics Home Reference related topics:
osteogenesis imperfecta
MedlinePlus related topics:
Osteogenesis Imperfecta
Genetic and Rare Diseases Information Center resources:
Osteogenesis Imperfecta
Osteogenesis Imperfecta Type VI
Osteogenesis Imperfecta Type III
Osteogenesis Imperfecta Type IV
Mucopolysaccharidosis Type IV
U.S. FDA Resources
Further study details as provided by Mereo BioPharma:
Primary Outcome Measures:
- Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 6 months ]High Resolution Peripheral Quantitative Computated Tomography
- Change in bone strength on Finite Element Analysis (N) [ Time Frame: 6 months ]High Resolution Peripheral Quantitative Computated Tomography
Secondary Outcome Measures:
- 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
Other Outcome Measures:
- 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
| Estimated Enrollment: | 140 |
| Anticipated Study Start Date: | September 30, 2017 |
| Estimated Study Completion Date: | May 31, 2019 |
| Estimated Primary Completion Date: | June 30, 2018 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: BPS804 Dose 1
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
|
|
Experimental: BPS804 Dose 2
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
|
|
Experimental: BPS804 Dose 3
BPS804 IV Infusion
|
Drug: BPS804
Intravenous infusion
|
|
Sham Comparator: Placebo - 5% Dextrose IV Infusion
5% Dextrose IV Infusion
|
Drug: Placebo IV Infusion 5% Dextrose
Intravenous infusion
|
Eligibility| Ages Eligible for Study: | 18 Years and older (Adult, Senior) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
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 24 months
- Capable of giving signed consent
Exclusion Criteria:
- History of skeletal malignancies or other bone diseases (other than OI)
- 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
Contacts and Locations
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, see Learn About Clinical Studies.
Please refer to this study by its ClinicalTrials.gov identifier: NCT03118570
Show 27 Study Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT03118570
Contacts
| Contact: Ian Hodgson, PhD | +44 3330237300 | enquiries@mereobiopharma.com | |
| Contact: Anthony Hall, MB BS BSc | +44 3330237300 | enquiries@mereobiopharma.com |
Show 27 Study Locations
Sponsors and Collaborators
Mereo BioPharma
ICON Clinical Research
Investigators
| 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 |
More Information
Additional Information:
| Responsible Party: | Mereo BioPharma |
| ClinicalTrials.gov Identifier: | NCT03118570 History of Changes |
| Other Study ID Numbers: |
MBPS205 2016-005096-27 ( EudraCT Number ) |
| Study First Received: | April 3, 2017 |
| Last Updated: | September 7, 2017 |
| 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 | |
Keywords provided by Mereo BioPharma:
|
Osteogenesis Imperfecta Brittle Bone Disease |
Additional relevant MeSH terms:
|
Osteogenesis Imperfecta Osteochondrodysplasias Bone Diseases, Developmental Bone Diseases |
Musculoskeletal Diseases Genetic Diseases, Inborn Collagen Diseases Connective Tissue Diseases |
ClinicalTrials.gov processed this record on September 21, 2017