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

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• Recruitment Status: Withdrawn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

Tracking Information

• First Submitted Date: July 12, 2017
• First Posted Date: July 13, 2017
• Last Update Posted Date: December 22, 2017
• Estimated Study Start Date: October 31, 2017
• Estimated Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: July 12, 2017)

• Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]
  High Resolution Peripheral Quantitative Computated Tomography
• Change in radial bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]
  High Resolution Peripheral Quantitative Computated Tomography

• Original Primary Outcome Measures: Same as current
• Change History: Complete list of historical versions of study NCT03216486 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures (submitted: July 12, 2017)

• Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3) [ Time Frame: 12 months ]
  High Resolution Peripheral Quantitative Computated Tomography
• Change in tibial bone strength on Finite Element Analysis (N) [ Time Frame: 12 months ]
  High Resolution Peripheral Quantitative Computated Tomography

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
• 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
• 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.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Phase 2

Study Design

Intervention Model: Single Group Assignment
Intervention Model Description:

Single arm, open-label

Masking: None (Open Label)
Primary Purpose: Treatment

• Condition: Osteogenesis Imperfecta

Intervention

Drug: BPS804

IV administration of BPS804 in 5% Dextrose solution

Study Arms

Experimental: BPS804 Dose 1

BPS804 IV Infusion

Intervention: Drug: BPS804

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Withdrawn
• Actual Enrollment (submitted: December 21, 2017): 0
• Original Estimated Enrollment (submitted: July 12, 2017): 10
• Estimated Study Completion Date: November 1, 2018
• Estimated Primary Completion Date: November 1, 2018 (Final data collection date for primary outcome measure)

Eligibility 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

Sex/Gender

• Sexes Eligible for Study: All

• Ages: 18 Years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT03216486
• Other Study ID Numbers: MBPS208
• Has Data Monitoring Committee: No

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: Not Provided
• Responsible Party: Mereo BioPharma
• Study Sponsor: Mereo BioPharma
• Collaborators: ICON Clinical Research

Investigators

• Principal Investigator: Reid Sutton, Prof.; Baylor College of Medicine

• PRS Account: Mereo BioPharma
• Verification Date: December 2017