Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT02163577 · ClinicalTrials.gov registry record · Phase 2
Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)
A Phase 2 study, sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 52
- Enrollment target
NCT02163577 is a Phase 2 study that has completed, run by Kyowa Kirin. The registered enrollment target is 52 participants.
The verdict
NCT02163577, a Phase 2 study, has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 52 participants
- Enrollment target
Study Summary
The objectives of the study are to: * Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants * Establish the safety profile of burosumab for the treatment of children with XLH including ectopic mineralization risk, cardiovascular effects, and immunogenicity profile * Characterize the pharmacokinetic (PK)/PD profile of the KRN23 doses tested in the monthly (Q4) and biweekly (Q2) dose regimens in pediatric XLH patients * Determine the PD effects of burosumab treatment on markers of bone health in pediatric XLH patients * Obtain a preliminary assessment of the clinical effects of burosumab on bone health and deformity, muscle strength, and motor function * Obtain a preliminary assessment of the effects of burosumab on participant-reported outcomes, including pain, disability, and quality of life in pediatric XLH patients * Evaluate the long-term safety and efficacy of burosumab
Interventions
- BIOLOGICAL burosumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 52 participants |
| Start Date | 2014-07-02 |
| Est. Completion | 2018-10-30 |
| Phase | Phase 2 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02163577
The ClinicalTrials.gov registry entry for NCT02163577 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 52 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Kyowa Kirin, which has 34 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 1 intervention - of which burosumab is the first listed.
NCT02163577 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02163577 about?
NCT02163577 is a clinical study titled "Study of KRN23 (Burosumab), a Recombinant Fully Human Monoclonal Antibody Against Fibroblast Growth Factor 23 (FGF23), in Pediatric Subjects With X-linked Hypophosphatemia (XLH)". The objectives of the study are to: * Identify a dose and dosing regimen of burosumab, based on safety and pharmacodynamic (PD) effect, in pediatric XLH participants * Establish the safety profile of burosumab for the treatment of children with XLH including ectopic mineralization risk, cardiovascu...
What is the current status of trial NCT02163577?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 52 participants. The study started on 2014-07-02. Estimated completion is 2018-10-30.
What interventions are being tested in trial NCT02163577?
The interventions under investigation include: burosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02163577?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
Explore more on PlainTrial
Read our methodology - how this data is sourced, computed, and verified.
Related
Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.