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

Primary Purpose

Osteogenesis Imperfecta

Status
Withdrawn
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
BPS804
Sponsored by
Ultragenyx Pharmaceutical Inc
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Osteogenesis Imperfecta

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Mereo Investigator Site
  • Mereo Investigator Site

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

BPS804 Dose 1

Arm Description

BPS804 IV Infusion

Outcomes

Primary Outcome Measures

Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
High Resolution Peripheral Quantitative Computated Tomography
Change in radial bone strength on Finite Element Analysis (N)
High Resolution Peripheral Quantitative Computated Tomography

Secondary Outcome Measures

Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
High Resolution Peripheral Quantitative Computated Tomography
Change in tibial bone strength on Finite Element Analysis (N)
High Resolution Peripheral Quantitative Computated Tomography

Full Information

First Posted
July 12, 2017
Last Updated
June 29, 2023
Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Mereo BioPharma
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1. Study Identification

Unique Protocol Identification Number
NCT03216486
Brief Title
An Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta
Acronym
Meteoroid
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
Study Type
Interventional

2. Study Status

Record Verification Date
June 2023
Overall Recruitment Status
Withdrawn
Why Stopped
Administrative Reason
Study Start Date
October 31, 2017 (Anticipated)
Primary Completion Date
November 1, 2018 (Anticipated)
Study Completion Date
November 1, 2018 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Ultragenyx Pharmaceutical Inc
Collaborators
Mereo BioPharma

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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
This study was previously posted by Mereo Biopharma and was transferred to Ultragenyx in February 2021.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Osteogenesis Imperfecta

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Single arm, open-label
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)

8. Arms, Groups, and Interventions

Arm Title
BPS804 Dose 1
Arm Type
Experimental
Arm Description
BPS804 IV Infusion
Intervention Type
Drug
Intervention Name(s)
BPS804
Intervention Description
IV administration of BPS804 in 5% Dextrose solution
Primary Outcome Measure Information:
Title
Change in radial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
Description
High Resolution Peripheral Quantitative Computated Tomography
Time Frame
12 months
Title
Change in radial bone strength on Finite Element Analysis (N)
Description
High Resolution Peripheral Quantitative Computated Tomography
Time Frame
12 months
Secondary Outcome Measure Information:
Title
Change in tibial Trabecular Volumetric Bone Mineral Density (mgHA/cm3)
Description
High Resolution Peripheral Quantitative Computated Tomography
Time Frame
12 months
Title
Change in tibial bone strength on Finite Element Analysis (N)
Description
High Resolution Peripheral Quantitative Computated Tomography
Time Frame
12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Medical Director
Organizational Affiliation
Ultragenyx Pharmaceutical Inc
Official's Role
Study Director
Facility Information:
Facility Name
Mereo Investigator Site
City
Albuquerque
State/Province
New Mexico
ZIP/Postal Code
87106
Country
United States
Facility Name
Mereo Investigator Site
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States

12. IPD Sharing Statement

Learn more about this trial

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

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