A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)

Part of paid clinical trials in Birmingham, Alabama.

Sponsor
Incyte Corporation
Study ID
NCT02553330
Phase
PHASE2
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Accepted

Interventions

Study Details

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

Key Dates

Start date
Nov 18, 2015
Status verified
Nov 2020
Primary completion
Oct 3, 2017
Completion
Oct 3, 2017

Study Design

Enrollment
90 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Ruxolitinib Phosphate Cream
    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.
  • Placebo Comparator: Placebo Cream
    Part B: Double-blind treatment is 24 weeks (and/or treatment with Ruxolitinib Phosphate Cream if eligible) and follow-up is an additional 12 weeks.

Primary Outcome Measure

Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented). [ Time Frame: Up to Week 24 ]

Locations (18)

FacilityCityStateZIPSite coordinators
-BirminghamAlabama--
-Hot SpringsArkansas--
-New HavenConnecticut--
-TrumbullConnecticut--
-MiamiFlorida--
-BeverlyMassachusetts--
-BostonMassachusetts--
-Clinton TownshipMichigan--
-Fort GratiotMichigan--
-FridleyMinnesota--
-MinneapolisMinnesota--
-Winston-SalemNorth Carolina--
-ClevelandOhio--
-PortlandOregon--
-AustinTexas--
-HoustonTexas--
-KatyTexas--
-NorfolkVirginia--

Related Studies