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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 : Recruiting
First Posted : April 18, 2017
Last Update Posted : February 5, 2018
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma

Study Description
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Brief Summary:
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 or disease Intervention/treatment Phase
Osteogenesis Imperfecta, Type I Osteogenesis Imperfecta Type III Osteogenesis Imperfecta Type IV Drug: BPS804 Drug: Placebo IV Infusion 5% Dextrose Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 140 participants
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
Actual Study Start Date : September 11, 2017
Estimated Primary Completion Date : June 30, 2018
Estimated Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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


Outcome Measures
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Primary Outcome Measures :
  1. Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 6 months ]
    High Resolution Peripheral Quantitative Computated Tomography

  2. Change in bone strength on Finite Element Analysis (N) [ Time Frame: 6 months ]
    High Resolution Peripheral Quantitative Computated Tomography


Secondary Outcome Measures :
  1. Change in Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]
    High Resolution Peripheral Quantitative Computative Tomography

  2. Change in bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]
    High Resolution Peripheral Quantitative Computative Tomography

  3. Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]
    OI-QOL-A

  4. Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]
    SF-12

  5. Change in Quality of Life Patient Reported Outcome Scores (total & sub-domains) [ Time Frame: 6 and 12 months ]
    EQ5D

  6. Changes in lumbar bone mineral density (t-score) [ Time Frame: 6 and 12 months ]
    Dual-energy x-ray absorptiometry

  7. Changes in whole body bone mineral density (t-score) [ Time Frame: 6 and 12 months ]
    Dual-energy x-ray absorptiometry

  8. Changes in proximal femur bone mineral density (t-score) [ Time Frame: 6 and 12 months ]
    Dual-energy x-ray absorptiometry


Other Outcome Measures:
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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
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Information from the National Library of Medicine

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


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
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Additional Information:
Study Website  This link exits the ClinicalTrials.gov site

Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT03118570     History of Changes
Other Study ID Numbers: MBPS205
2016-005096-27 ( EudraCT Number )
First Posted: April 18, 2017    Key Record Dates
Last Update Posted: February 5, 2018
Last Verified: February 2018
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