Overview

Study of KRN23, a Recombinant Fully Human Monoclonal Antibody Against FGF23, in Pediatric Subjects With X-linked Hypophosphatemia (XLH)

Status:
Active, not recruiting

Trial end date:
0000-00-00

Target enrollment:

Participant gender:

Summary

UX023-CL201 is a randomized, multicenter, open-label, dose finding, Phase 2 study. The study will be conducted in prepubescent children aged 5-12 years with XLH to assess the pharmacodynamics and safety of KRN23 administered via subcutaneous injections monthly (every 4 weeks) or biweekly (every 2 weeks) for a total of 64 weeks. The study consists of a 16-week individual dose Titration Period, followed by a 48-week Treatment Period. The study will enroll approximately 50 pediatric patients with XLH and radiographic evidence of bone disease. Subjects will need to discontinue oral phosphate and vitamin D metabolite therapy prior to randomization and throughout the duration of the study.

Phase:

Phase 2

Details

Lead Sponsor:

Ultragenyx Pharmaceutical Inc

Collaborator:

Kyowa Hakko Kirin Korea Co., Ltd.

Treatments:

Antibodies