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Monoclonal Antibodies

KRN23 for Vitamin D-resistant rickets

Phase 1 & 2
Waitlist Available
Research Sponsored by Kyowa Kirin Co., Ltd.
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 13.5 months,(50 visits)
Awards & highlights
All Individual Drugs Already Approved
No Placebo-Only Group

Summary

The primary purpose of this study is to assess the safety and efficacy of repeated subcutaneous (SC) injections of KRN23 in adult subjects with X-Linked Hypophosphatemia (XLH).

Eligible Conditions
  • Vitamin D-resistant rickets

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~13.5 months,(50 visits)
This trial's timeline: 3 weeks for screening, Varies for treatment, and 13.5 months,(50 visits) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Safety and Efficacy of Repeated SC Injections of KRN23.
Secondary study objectives
Evaluation of Effect of Repeated SC Injections of KRN23
Other study objectives
Evaluation of Effect of Repeated SC Injections of KRN23 in Bone Substudy

Side effects data

From 2014 Phase 1 & 2 trial • 23 Patients • NCT01571596
100%
OROPHARYNGEAL PAIN
100%
GASTROOESOPHAGEAL REFLUX DISEASE
100%
LIP ULCERATION
100%
INJECTION SITE PAIN
100%
GINGIVAL ULCERATION
100%
INJECTION SITE HAEMATOMA
100%
NASOPHARYNGITIS
100%
GINGIVAL INJURY
100%
COUGH
100%
HEADACHE
100%
80%
60%
40%
20%
0%
Study treatment Arm
Bone Substudy KRN23
KRN23
Bone Substudy Placebo

Awards & Highlights

All Individual Drugs Already Approved
Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: KRN23Experimental Treatment1 Intervention
Escalating doses of KRN23 (0.05, 0.10, 0.30, and 0.60 mg/kg) will be administered SC every 28 days (up to 12 doses)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Burosumab
FDA approved

Find a Location

Who is running the clinical trial?

Kyowa Hakko Kirin Pharma, Inc.Industry Sponsor
22 Previous Clinical Trials
1,533 Total Patients Enrolled
Kyowa Kirin Co., Ltd.Lead Sponsor
175 Previous Clinical Trials
28,186 Total Patients Enrolled
Amy Zhang, PhDStudy DirectorKyowa Hakko Kirin Pharma, Inc.
2 Previous Clinical Trials
49 Total Patients Enrolled
~2 spots leftby Nov 2025
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