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Open Label Trial Assessing Safety and Efficacy of Burosumab (KRN23), in a Patient With ENS and Hypophosphatemic Rickets

NCT03581591 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 1

Last updated 2020-01-18

No results posted yet for this study

Summary

A 52 week, open label trial to assess the safety and efficacy of KRN23, an investigational antibody to FGF23, in a single pediatric patient with Epidermal Nevus Syndrome(ENS) and associated hypophosphatemic rickets

A 26 weeks extension to original study to monitor patient lab results for her safety.

Conditions

  • Hypophosphatemia
  • Hypophosphatemic Rickets
  • Pain, Chronic

Interventions

BIOLOGICAL

Burosumab

recombinant human IgG1 monoclonal antibody to fibroblast growth factor 23)

Sponsors & Collaborators

Principal Investigators

  • Jeffrey Sugarman, MD PhD · Redwood Dermatology Sciences

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Max Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-01-31
Primary Completion
2019-12-06
Completion
2019-12-06
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03581591 on ClinicalTrials.gov