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An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta (METEOROID)

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ClinicalTrials.gov Identifier: NCT03216486
Recruitment Status : Withdrawn (Administrative Reason)
First Posted : July 13, 2017
Last Update Posted : December 22, 2017
Sponsor:
Collaborator:
ICON Clinical Research
Information provided by (Responsible Party):
Mereo BioPharma

Brief Summary:
The purpose of this study is to investigate the effect of BPS804 on strength/quality of bone in patients with Type I, III or IV Osteogenesis imperfecta using a special type of CT scanner. Participants will be treated for 1 year.

Condition or disease Intervention/treatment Phase
Osteogenesis Imperfecta Drug: BPS804 Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 0 participants
Intervention Model: Single Group Assignment
Intervention Model Description: Single arm, open-label
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Estimated Study Start Date : October 31, 2017
Estimated Primary Completion Date : November 1, 2018
Estimated Study Completion Date : November 1, 2018


Arm Intervention/treatment
Experimental: BPS804 Dose 1
BPS804 IV Infusion
Drug: BPS804
IV administration of BPS804 in 5% Dextrose solution




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

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


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

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



Information from the National Library of Medicine

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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
  • 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

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): NCT03216486


Locations
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United States, New Mexico
Mereo Investigator Site
Albuquerque, New Mexico, United States, 87106
United States, Texas
Mereo Investigator Site
Houston, Texas, United States, 77030
Sponsors and Collaborators
Mereo BioPharma
ICON Clinical Research
Investigators
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Principal Investigator: Reid Sutton, Prof. Baylor College of Medicine

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Responsible Party: Mereo BioPharma
ClinicalTrials.gov Identifier: NCT03216486     History of Changes
Other Study ID Numbers: MBPS208
First Posted: July 13, 2017    Key Record Dates
Last Update Posted: December 22, 2017
Last Verified: December 2017

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Osteogenesis Imperfecta
Osteochondrodysplasias
Bone Diseases, Developmental
Bone Diseases
Musculoskeletal Diseases
Genetic Diseases, Inborn
Collagen Diseases
Connective Tissue Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs