Long-term Extension Study of Setrusumab in Adults With Type I, III, or IV Osteogenesis Imperfecta

  • STATUS
    Recruiting
  • End date
    Jun 18, 2026
  • participants needed
    112
  • sponsor
    Ultragenyx Pharmaceutical Inc
Updated on 18 June 2022

Summary

The primary objective of the study is to evaluate bone mineral density (BMD) after 12 months of retreatment with monthly setrusumab in adults with osteogenesis imperfecta (OI).

Description

UX143-CL203 is a long-term extension study in adults with OI who participated in the ASTEROID study (also referred to as MBPS205) [NCT03118570]. The UX143-CL203 study comprises Observation, Retreatment, and Extension Periods. There is no intervention during the Observation Period. During the single-arm Retreatment Period, participants receive open-label setrusumab once a month (QM) for 12 months. Following the Retreatment Period, participants enter an Extension Period in which they will continue treatment with open-label setrusumab at different dosing frequencies.

Details
Condition Osteogenesis Imperfecta
Treatment Setrusumab
Clinical Study IdentifierNCT05312697
SponsorUltragenyx Pharmaceutical Inc
Last Modified on18 June 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Males or females who participated in the Phase 2b ASTEROID study
Females of childbearing potential must consent to use highly effective contraception during the Observation, Retreatment, and Extension Periods through 2 months after the last dose of setrusumab and agree not to become pregnant

Exclusion Criteria

Known hypersensitivity to setrusumab or its excipients that, in the judgment of the Investigator, places the participant at increased risk for adverse effects
Presence or history of any condition that, in the view of the Investigator, would interfere with participation, pose undue risk, or would confound interpretation of results
Pregnant or breastfeeding or planning to become pregnant (self or partner) at any time during the study
Not willing or able to discontinue bisphosphonates 6 months prior to the Retreatment Screening Visit
Once enrolled in UX143-CL203, individuals who meet any of the following exclusion criteria
will not be eligible to participate in the Retreatment Period
Concurrent participation in any study that is examining the safety and efficacy of any
investigational product or investigational medical device that alters bone health
during the Retreatment and Extension Periods, per discretion of the Investigator in
consultation with the Medical Monitor
Calcium levels outside the normal range at the Retreatment Screening Visit. If the
participant's calcium level is not within the normal range, decision to retest should
be made in conjunction with the Medical Monitor
Glomerular filtration rate (GFR) ≤ 29 mL/min at the Retreatment Screening Visit. If
the participant's GFR is ≤ 29 mL/min, decision to retest should be made in conjunction
with the Medical Monitor
History of skeletal malignancies or bone metastases at any time
History of neural foraminal stenosis (except if due to scoliosis)
History of myocardial infarction, angina pectoris, ischemic stroke or transient
ischemic attack (Investigators should consider whether the potential benefits of
treatment outweigh the potential risks in patients with other cardiovascular risk
factors such as hypertension, hyperlipidemia, familial hyperlipidemia, family history
of premature ischemic cardiovascular disease, smoking, diabetes mellitus, and
metabolic syndrome.)
History of or concomitant uncontrolled diseases such as hypo-/hyperparathyroidism
hypo-/hyperthyroidism, Paget's disease, abnormal thyroid function or thyroid disease
or other endocrine disorders or conditions that could affect bone metabolism eg, Stage
IV/V renal disease
A history of rickets or osteomalacia or any skeletal condition (other than OI) leading
to long-bone deformities and/or increased risk of fractures
Documented alcohol and/or drug abuse within 12 months prior to dosing or evidence of
such abuse as indicated by the laboratory results during the screening/baseline
assessments
Documented history of significant psychiatric or medical disorder that would prevent
the participant complying with the requirements of the protocol or would make it
unsafe for the participant to participate in the study as judged by the investigator
Current/previously reported allergy to the study drug or any of its excipients or the
class of drug under investigation
History of external radiation
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