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NCT02304367 · ClinicalTrials.gov registry record · Phase 2
Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)
A Phase 2 study of Tumor-induced Osteomalacia (TIO) and Epidermal Nevus Syndrome (ENS), sponsored by Kyowa Kirin.
- Completed
- Registry status
- Phase 2
- Development phase
- 17
- Enrollment target
- 7
- Study locations
NCT02304367: Completed Phase 2 study of Tumor-induced Osteomalacia (TIO) and Epidermal Nevus Syndrome (ENS), sponsored by Kyowa Kirin.
NCT02304367 is a Phase 2 study of Tumor-induced Osteomalacia (TIO) and Epidermal Nevus Syndrome (ENS) that has completed, run by Kyowa Kirin. The registered enrollment target is 17 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower). The trial reports 7 study locations across 7 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02304367, a Phase 2 study of Tumor-induced Osteomalacia (TIO) and Epidermal Nevus Syndrome (ENS), has completed, sponsored by Kyowa Kirin.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 17 participants
- Enrollment target
- 7
- Study locations
Study Summary
The primary objectives of this study are to evaluate the effect of burosumab treatment on: * Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia * Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface (OS/BS), osteoid volume/bone volume (OV/BV) and mineralization lag time (MLt).
Primary Outcome
The percentage of participants achieving mean serum phosphorus levels above the lower limit of normal (LLN; 2.5 mg/dL \[0.81 mmol/L\]) at the mid-point of the dose interval (2 weeks after dosing), as averaged across dose cycles between Baseline and Week 24 (i.e. the average of serum phosphorus levels at Weeks 2, 6, 10, 14 and 22).
Conditions Studied
Interventions
- BIOLOGICAL Burosumab
Study Locations (7)
Colorado
- Colorado Center for Bone Research at Panorama Orthopedics and Spine Center - Golden
Connecticut
- Yale University School of Medicine - New Haven
Indiana
- Indiana University Hospital - Indianapolis
Maryland
- Johns Hopkins University - Baltimore
Minnesota
- Mayo Clinic - Rochester
North Carolina
- Duke University - Durham
Texas
- Houston Methodist Research Institute - Houston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 17 participants |
| Start Date | 2015-03-24 |
| Est. Completion | 2021-01-21 |
| Phase | Phase 2 |
What the finished NCT02304367 record still lists
NCT02304367 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 17 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (87% lower).
The record links to 2 conditions, with Tumor-induced Osteomalacia (TIO) appearing as the primary indexed condition, and to 1 intervention - of which Burosumab is the first listed.
NCT02304367 lists 7 locations in 7 states (Colorado, Connecticut, Indiana).
Frequently Asked Questions
What is clinical trial NCT02304367 about?
NCT02304367 is a clinical study titled "Study of Burosumab (KRN23) in Adults With Tumor-Induced Osteomalacia (TIO) or Epidermal Nevus Syndrome (ENS)". The primary objectives of this study are to evaluate the effect of burosumab treatment on: * Increasing serum phosphorus levels in adults with TIO or ENS-associated osteomalacia * Improvement in TIO/ENS-associated osteomalacia as determined by osteoid thickness (O.Th), osteoid surface/bone surface ...
What is the current status of trial NCT02304367?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 17 participants. The study started on 2015-03-24. Estimated completion is 2021-01-21.
What conditions does trial NCT02304367 study?
This clinical trial studies the following conditions: Tumor-induced Osteomalacia (TIO), Epidermal Nevus Syndrome (ENS).
What interventions are being tested in trial NCT02304367?
The interventions under investigation include: Burosumab (BIOLOGICAL).
Who is sponsoring clinical trial NCT02304367?
This trial is sponsored by Kyowa Kirin, which has 34 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02304367 being conducted?
This trial has 7 study locations across Colorado, Connecticut, Indiana, Maryland, Minnesota. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT02304367's enrollment target sits among peer trials
17 1903rd of 2000 higher than 93 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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