Topical INCB018424 Lichen Planus

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Aaron R. Mangold，Mayo Clinic

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 5, 2018

Last Update Posted Date

October 5, 2018

Actual Study Start Date ^ICMJE

August 30, 2018

Estimated Primary Completion Date

November 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

modified CAILS[ Time Frame: week 0 to week 4 ]

lesion count[ Time Frame: week 0 to week 4 ]

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

Pruritus NRS[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Skindex-16[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Physician Global Assessment[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
Body Surface Area[ Time Frame: week 0 to week 4, week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
modified CAILS[ Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]
lesion count[ Time Frame: week 0 to week 8, weeks 4 to 8, weeks 8 to 12 ]

Descriptive Information

Brief Title ^ICMJE

Topical INCB018424 Lichen Planus

Official Title ^ICMJE

INCB018424 in the Treatment of Cutaneous Lichen Planus

Brief Summary

To evaluate the safety and efficacy of INCB018424 PHOSPHATE CREAM in cutaneous LP as assessed by the change in Physician Global Assessment (PGA), Body Surface Area (BSA), Index Treatment and Control Lesion by Clinical Assessment Scale of Severity for Index Lesion Signs and Symptoms (CAILS) score, Pruritus Numerical Rating Scale (NRS), and Skindex-16. To predict responses through the identification of unique biomarkers of LP at week 0 and utilizing RNA sequencing on responsive and non-responsive tissue at week 4.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 2

Study Design ^ICMJE

Allocation:
Intervention Model: Single Group Assignment
Intervention Model Description: Topical INCB018424
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: INCB018424
Topical cream

Study Arms

Experimental: INCB018424
INCB018424 Cream

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

July 2020

Estimated Primary Completion Date

November 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Subjects must be able to understand and comply with the requirements of the study and communicate with the investigator. Subjects must give written, signed, and dated informed consent before any study related activity is performed. When appropriate, a legal representative will sign the informed consent according to local laws and regulation Both men and women must be at least 18 years of age at the time of screening Subjects must have clinical and histological features of LP LP must involve between 2 and 20% of the BSA Subjects must have a minimum of 10 lesions of LP Subjects must have treatment naive cutaneous LP or treatment refractory disease, as defined by failure of at least one established treatment for LP Failure of prior therapy Topical treatment Systemic immunosuppressant Oral metronidazole Oral sulfasalazine Oral retinoid

Sex/Gender

Sexes Eligible for Study:

All

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

United States

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Aaron R. Mangold，Mayo Clinic

Study Sponsor ^ICMJE

Aaron R. Mangold

Collaborators ^ICMJE

Investigators ^ICMJE

Principal Investigator: Aaron R Mangold Mayo Clinic

PRS Account

Mayo Clinic

Verification Date

October 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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