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

June 29, 2023 updated by: Ultragenyx Pharmaceutical Inc

A Phase 2, Non-controlled, Open-Label, Exploratory Study of BPS804 Treatment in Adult Patients With Type I, III or IV Osteogenesis Imperfecta

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.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Mereo Investigator Site
    • Texas
      • Houston, Texas, United States, 77030
        • Mereo Investigator Site

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Ultragenyx Pharmaceutical Inc

Collaborators

Mereo BioPharma

Investigators

  • Study Director: Medical Director, Ultragenyx Pharmaceutical Inc

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

October 31, 2017

Primary Completion (Estimated)

November 1, 2018

Study Completion (Estimated)

November 1, 2018

Study Registration Dates

First Submitted

July 12, 2017

First Submitted That Met QC Criteria

July 12, 2017

First Posted (Actual)

July 13, 2017

Study Record Updates

Last Update Posted (Actual)

July 3, 2023

Last Update Submitted That Met QC Criteria

June 29, 2023

Last Verified

June 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MBPS208

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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