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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.
See Contacts and Locations
Verified May 2017 by Mereo BioPharma
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma
ClinicalTrials.gov Identifier:
NCT03118570
First received: April 3, 2017
Last updated: June 22, 2017
Last verified: May 2017
  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: 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:


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: June 26, 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

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: June 22, 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 July 24, 2017