Overview

This trial is active, not recruiting.

Condition alopecia areata
Treatments placebo cream, incb018424 phosphate cream
Phase phase 2
Sponsor Incyte Corporation
Start date October 2015
End date May 2018
Trial size 90 participants
Trial identifier NCT02553330, INCB 18424-204

Summary

A phase 2 study to find out if the drug INCB018424 Phosphate Cream is safe and has beneficial effects in people who have alopecia areata (partial or complete hair loss) when applied to the skin.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks; Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
incb018424 phosphate cream
(Placebo Comparator)
Part B: Double-blind treatment is 24 weeks (and/or treatment with INCB018424 Phosphate Cream if eligible) and follow-up is an additional 12 weeks.
placebo cream
incb018424 phosphate cream

Primary Outcomes

Measure
Percentage of subjects achieving a Severity of Alopecia Tool score (SALT) 50 response in terminal hair (pigmented and nonpigmented) at Week 24
time frame: 24 weeks

Secondary Outcomes

Measure
Mean change from Baseline in SALT score through Week 24
time frame: 24 weeks

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Diagnosis of AA - Duration and extent of current episode of AA - Evidence of active hair loss Exclusion Criteria: - Evidence of diffuse, spontaneous terminal hair regrowth - Receipt of treatment known to potentially affect the course of AA within last month

Additional Information

Official title An Open-Label (Part A) and a Double-Blind, Randomized, Placebo Controlled (Part B) Study, With an Open-Label Extension, of INCB018424 Phosphate Cream Applied Topically to Subjects With Alopecia Areata
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Incyte Corporation.