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

June 29, 2023 updated by: Ultragenyx Pharmaceutical Inc

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)

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

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

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
112

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • Canada
    • Ontario
      • Toronto, Ontario, Canada
        • Mereo Investigator Site
    • Quebec
      • Montreal, Quebec, Canada
        • Mereo Investigator Site
      • Quebec City, Quebec, Canada
        • Mereo Investigator Site
  • Denmark
      • Aarhus, Denmark
        • Mereo Investigator Site
      • Odense, Denmark
        • Mereo Investigator Site
  • France
      • Lyon, France
        • Mereo Investigator Site
      • Paris, France
        • Mereo Investigator Site
    • Paris Cedex 14
      • Paris, Paris Cedex 14, France
        • Mereo Investigator Site
  • United Kingdom
      • Bristol, United Kingdom
        • Mereo Investigator Site
      • London, United Kingdom
        • Mereo Investigator Site
    • Cambridgeshire
      • Cambridge, Cambridgeshire, United Kingdom
        • Mereo Investigator Site
    • Newcastle
      • Newcastle upon Tyne, Newcastle, United Kingdom
        • Mereo Investigator Site
    • Oxfordshire
      • Oxford, Oxfordshire, United Kingdom
        • Mereo Investigator Site
  • United States
    • Alabama
      • Birmingham, Alabama, United States, 35294
        • Mereo Investigator Site
    • Florida
      • Jacksonville, Florida, United States, 32207
        • Mereo Investigator Site
    • Maryland
      • Baltimore, Maryland, United States, 21287
        • Mereo Investigator Site
    • Massachusetts
      • Boston, Massachusetts, United States, 012115
        • Mereo Investigator Site
    • Minnesota
      • Saint Paul, Minnesota, United States, 55101
        • Mereo Investigator Site
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Mereo Investigator Site
    • New Mexico
      • Albuquerque, New Mexico, United States, 87106
        • Mereo Investigator Site
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Mereo Investigator Site
    • Oregon
      • Portland, Oregon, United States, 97239
        • Mereo Investigator Site
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15225
        • Mereo Investigator Site
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

14 years to 71 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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, denosumab or other anabolic/anti-reabsorptive 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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Setrusumab 20 mg/kg (Blinded)
Setrusumab 20 mg/kg intravenous (IV) infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Intravenous infusion
Other Names:
  • BPS804
Dietary supplement: Calcium
tablets
Dietary supplement: Vitamin D
capsules
Drug: zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Experimental: Setrusumab 8 mg/kg (Blinded)
Setrusumab 8 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Intravenous infusion
Other Names:
  • BPS804
Dietary supplement: Calcium
tablets
Dietary supplement: Vitamin D
capsules
Drug: zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Experimental: Setrusumab 2 mg/kg (Blinded)
Setrusumab 2 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Intravenous infusion
Other Names:
  • BPS804
Dietary supplement: Calcium
tablets
Dietary supplement: Vitamin D
capsules
Drug: zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Experimental: Setrusumab 20 mg/kg (Open-Label)
Setrusumab 20 mg/kg IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Drug: setrusumab
Intravenous infusion
Other Names:
  • BPS804
Dietary supplement: Calcium
tablets
Dietary supplement: Vitamin D
capsules
Drug: zoledronic acid (optional)
Following completion of the study treatment (Month 12) participants can receive an optional single dose of zoledronic acid. Participants can receive an optional further dose of zoledronic acid at Month 18 at the discretion of their treating physician.
Placebo Comparator: Placebo
Placebo IV infusion once a month for 12 months plus 500 mg calcium oral tablets and 800 IU vitamin D capsules.
Dietary supplement: Calcium
tablets
Dietary supplement: Vitamin D
capsules

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Radial Trabecular Volumetric Bone Mineral Density (Tr vBMD) at Month 12
Time Frame: Baseline, Month 12 (end of treatment [EOT])
Assessed by high resolution peripheral quantitative computed tomography (HRpQCT). HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presents the ratio of the means between the visit and Baseline from analysis of covariance (ANCOVA).
Baseline, Month 12 (end of treatment [EOT])
Change From Baseline in Radial Bone Strength (Failure Load) at Month 12
Time Frame: Baseline, Month 12 (EOT)
Assessed by finite element analysis (FEA) of models generated from HRpQCT images of the distal radius.
Baseline, Month 12 (EOT)
Change From Baseline in Radial Bone Strength (Stiffness) at Month 12
Time Frame: Baseline, Month 12 (EOT)
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Month 12 (EOT)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Change From Baseline in Radial and Tibial Tr VBMD Over Time: Full Analysis Set
Time Frame: Baseline, Months 6, 12 (EOT), 18, 24
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, 24
Changes From Baseline in Radial and Tibial Tr VBMD at Months 6 and 12: Open-Label Arm
Time Frame: Baseline, Months 6, 12 (EOT)
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT)
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) Over Time: Full Analysis Set
Time Frame: Baseline, Months 6, 12 (EOT), 18, 24
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT), 18, 24
Changes From Baseline in Radial and Tibial Bone Strength (Failure Load) at Months 6 and 12: Open-Label Arm
Time Frame: Baseline, Months 6, 12 (EOT)
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT)
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) Over Time: Full Analysis Set
Time Frame: Baseline, Months 6, 12 (EOT), 18, 24
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT), 18, 24
Changes From Baseline in Radial and Tibial Bone Strength (Stiffness) at Months 6 and 12: Open-Label Arm
Time Frame: Baseline, Months 6, 12 (EOT)
Assessed by FEA of models generated from HRpQCT images of the distal radius.
Baseline, Months 6, 12 (EOT)
Percentage of Participants With at Least 1 New Fracture (Peripheral, Vertebral, Long-Bone, Any) at Month 12
Time Frame: Month 12 (EOT)
Fracture assessment, confirmed by central radiographic reading, was carried out for peripheral including all major long bones, minor bone (digits, ribs) and vertebral fractures. Fractures without clinical symptoms, detected only by means of radiographic investigations, were not included in the analysis.
Month 12 (EOT)
Change From Baseline in Lumbar, Total Body, and Femoral Neck Bone Mineral Density (BMD) T-score at Month 6
Time Frame: Baseline, Month 6
BMD was evaluated by dual-energy x-ray absorptiometry (DXA). T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Baseline, Month 6
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 6
Time Frame: Baseline, Month 6
BMD was evaluated by DXA.
Baseline, Month 6
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD T-score at Month 12
Time Frame: Baseline, Month 12 (EOT)
BMD was evaluated by DXA. T-Score was calculated based on actual measured bone density value. T-scores are standardized scores that reflect the standard deviations (SDs) above/below the normal mean for young adults. A score of 50 indicates the population mean with a standard deviation of 10. A positive change in DXA T-score indicates an improvement in BMD.
Baseline, Month 12 (EOT)
Change From Baseline in Lumbar, Total Body, and Femoral Neck BMD at Month 12
Time Frame: Baseline, Month 12 (EOT)
BMD was evaluated by DXA.
Baseline, Month 12 (EOT)
Change From Baseline in Total vBMD (Radial and Tibial) Over Time
Time Frame: Baseline, Months 6, 12 (EOT), 18, and 24
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, and 24
Change From Baseline in Cortical vBMD (Radial and Tibial) Over Time
Time Frame: Baseline, Months 6, 12 (EOT), 18, and 24
Assessed by HRpQCT. HRpQCT scans were performed on the participant's distal non-dominant arm. In cases of an arm that had been supported with rods or had significant deformity, the dominant limb was selected. Data presented is the ratio of the means between the Visit and Baseline from ANCOVA.
Baseline, Months 6, 12 (EOT), 18, and 24
Number of Participants With Clinically Significant Changes From Baseline in Body Height, Weight and Body Mass Index (BMI) at 6 and 12 Months: Full Analysis Set
Time Frame: Baseline, Month 6, Month 12 (EOT)
Baseline, Month 6, Month 12 (EOT)
Change From Baseline in Lean and Fat Body Mass From Whole Body at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
Lean and fat body mass was evaluated using whole body DXA (including the head).
Baseline, Months 6, 12 (EOT)
Change From Baseline in Amino-Terminal Propeptide of Type 1 Procollagen (P1NP) up to Month 12
Time Frame: Baseline, Months 1, 3, 6, 9, 12 (EOT)
Baseline, Months 1, 3, 6, 9, 12 (EOT)
Change From Baseline in Carboxy-Terminal Telo-Peptide [CTX-1] up to Month 12
Time Frame: Baseline, Months 1, 3, 6, 9, 12 (EOT)
Baseline, Months 1, 3, 6, 9, 12 (EOT)
Change From Baseline in Short Form 12 Health Survey (SF-12) Physical Component Summary Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Physical Component Summary ranges from 0 to 100, where higher scores reflect better physical functioning.
Baseline, Months 6, 12 (EOT)
Change From Baseline in SF-12 Mental Component Summary Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
The SF-12 is a generic, 12-item survey that measures 8 domains of health: physical functioning, role limitations due to physical health, bodily pain, general health perceptions, vitality, social functioning, role limitations due to emotional problems, and mental health. It yields scale scores for each of these 8 domains and 2 summary measures of physical and mental health: The Physical Component Summary and the Mental Component Summary. The total score for the Mental Component Summary ranges from 0 to 100, where higher scores reflect better mental health functioning.
Baseline, Months 6, 12 (EOT)
Change From Baseline in Index (Utility) Score on EuroQol 5-Dimension 5-Level Descriptive System (EQ-5D-5L) Score at Months 6 and 12
Time Frame: Baseline, Months 6 and 12 (EOT)
The EQ-5D-5L is a standardised measure of health status comprised of a descriptive system of 5 health-related quality of life states (i.e., mobility, self-care, usual activities, pain/discomfort, and anxiety/depression) and a Visual Analogue Scale (VAS) of overall health. Each dimension is rated on a 5-point response scale indicating severity of problems, where 1 is "no problems" and 5 is "extreme problems". The 5 questions are scored and together contribute to the EQ-5D index (utility) score between 0 and 1 (1 being perfect health).
Baseline, Months 6 and 12 (EOT)
Change From Baseline in Osteogenesis Imperfecta Specific Quality of Life Questionnaire for Adults (OIQoL-A) Total Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The total score is calculated on a 0-100 scale, where higher scores indicate a greater (negative) impact on quality of life.
Baseline, Months 6, 12 (EOT)
Change From Baseline in OIQoL-A Pain Subscale Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Pain subscale ranges from 0 to 10, with higher value representing worse pain.
Baseline, Months 6, 12 (EOT)
Change From Baseline in OIQoL-A Activity Subscale Score at Months 6 and 12
Time Frame: Baseline, Months 6, 12 (EOT)
The OIQoL-A measures 5 areas of quality of life related to OI (Physical Function, Pain, Hearing Loss, Taking Care/Concerns, Social and Family Life and Activities). The Activities subscale ranges from 0 to 100, with higher value representing increased difficulty.
Baseline, Months 6, 12 (EOT)
Percentage of Participants Who Were Positive for Anti-Setrusumab Antibodies at Any Time During the Study up to Month 14
Time Frame: up to Month 14
Serum samples were screened for antibodies binding to setrusumab using a validated assay method by or under the supervision of the sponsor.
up to Month 14
Percentage of Participants With Adverse Events (AEs), Treatment-Emergent AEs (TEAEs), Serious TEAEs, and TEAEs Leading to Discontinuation or Death
Time Frame: Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.)
An AE is any untoward medical occurrence, which does not necessarily have a causal relationship with treatment. A serious AE (SAE) is defined as any untoward medical occurrence that, at any dose: results in death; is life-threatening; requires inpatient hospitalization or prolongation of existing hospitalization; results in persistent disability/incapacity; is a congenital anomaly/birth defect; is another important medical event. The intensity for each AE was graded as mild, moderate or severe, according to the investigator's judgement. An event was considered related to study drug if there were a "reasonable possibility" of a relationship, according to the investigator's clinical judgment. A TEAE was defined as an event occurring or worsening on or after the first dose of study medication.
Non-serious AEs: up to Month 14; Serious AEs: up to Month 24. (Average duration of exposure to placebo was 5 months and for setrusumab was 11 month plus follow-up to 24 months.)

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Ultragenyx Pharmaceutical Inc

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Mereo BioPharma

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Medical Director, Mereo BioPharma

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 (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
September 11, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
October 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
November 12, 2020

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 3, 2017

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 13, 2017

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 18, 2017

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 5, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
June 29, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • MBPS205
  • 2016-005096-27 (EudraCT Number)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Conditions

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