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Trial record 3 of 6 for:    BPS804

A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804 (ASTEROID)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03118570
Recruitment Status : Active, not recruiting
First Posted : April 18, 2017
Last Update Posted : March 14, 2019
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma

Tracking Information
First Submitted Date  ICMJE April 3, 2017
First Posted Date  ICMJE April 18, 2017
Last Update Posted Date March 14, 2019
Actual Study Start Date  ICMJE September 11, 2017
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 15, 2018)
  • 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
Original Primary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
Change History Complete list of historical versions of study NCT03118570 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: April 13, 2017)
  • 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
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: April 13, 2017)
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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title  ICMJE A Study in Adult Patients With Type I, III or IV Osteogenesis Imperfecta Treated With BPS804
Official Title  ICMJE 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).
Brief Summary The purpose of this study is to select a suitable dose of BPS804 by measuring the strength/quality of bone using a special type of CT scanner. Participants will be treated for 12 months and followed up for a further 12 months.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE 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
Condition  ICMJE
  • Osteogenesis Imperfecta, Type I
  • Osteogenesis Imperfecta Type III
  • Osteogenesis Imperfecta Type IV
Intervention  ICMJE Drug: BPS804
Intravenous infusion
Other Name: setrusumab
Study Arms  ICMJE
  • Experimental: BPS804 Dose 1
    BPS804 IV Infusion
    Intervention: Drug: BPS804
  • Experimental: BPS804 Dose 2
    BPS804 IV Infusion
    Intervention: Drug: BPS804
  • Experimental: BPS804 Dose 3
    BPS804 IV Infusion
    Intervention: Drug: BPS804
  • Experimental: BPS804 Dose 4
    BPS804 IV Infusion
    Intervention: Drug: BPS804
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: August 15, 2018)
100
Original Estimated Enrollment  ICMJE
 (submitted: April 13, 2017)
140
Estimated Study Completion Date  ICMJE October 31, 2020
Estimated Primary Completion Date October 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Denmark,   France,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03118570
Other Study ID Numbers  ICMJE MBPS205
2016-005096-27 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Mereo BioPharma
Study Sponsor  ICMJE Mereo BioPharma
Collaborators  ICMJE ICON Clinical Research
Investigators  ICMJE
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
PRS Account Mereo BioPharma
Verification Date March 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP