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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02553330
Recruitment Status : Terminated (The study was terminated early based on the results of a planned interim analysis.)
First Posted : September 17, 2015
Last Update Posted : March 26, 2019
Sponsor:
Information provided by (Responsible Party):
Incyte Corporation

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Alopecia Areata (AA) Drug: Placebo Cream Drug: Ruxolitinib Phosphate Cream Phase 2

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 90 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: An Open-Label (Part A) and a Double-Blind, Randomized, Placebo Controlled (Part B) Study, With an Open-Label Extension, of Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata
Actual Study Start Date : October 2015
Actual Primary Completion Date : October 3, 2017
Actual Study Completion Date : October 3, 2017


Arm Intervention/treatment
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.

Drug: Ruxolitinib Phosphate Cream
Other Name: INCB018424

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.
Drug: Placebo Cream
Drug: Ruxolitinib Phosphate Cream
Other Name: INCB018424




Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. Mean change from Baseline in SALT score through Week 24 [ Time Frame: 24 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02553330


Locations
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United States, Alabama
Birmingham, Alabama, United States
United States, Arkansas
Hot Springs, Arkansas, United States
United States, Connecticut
New Haven, Connecticut, United States
Trumbull, Connecticut, United States
United States, Florida
Miami, Florida, United States
United States, Massachusetts
Beverly, Massachusetts, United States
Boston, Massachusetts, United States
United States, Michigan
Clinton Township, Michigan, United States
Fort Gratiot, Michigan, United States
United States, Minnesota
Fridley, Minnesota, United States
Minneapolis, Minnesota, United States
United States, North Carolina
Winston-Salem, North Carolina, United States
United States, Ohio
Cleveland, Ohio, United States
United States, Oregon
Portland, Oregon, United States
United States, Texas
Austin, Texas, United States
Houston, Texas, United States
Katy, Texas, United States
United States, Virginia
Norfolk, Virginia, United States
Sponsors and Collaborators
Incyte Corporation
Investigators
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Study Director: Kathleen Butler, MD Incyte Corporation

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Incyte Corporation
ClinicalTrials.gov Identifier: NCT02553330    
Other Study ID Numbers: INCB 18424-204
First Posted: September 17, 2015    Key Record Dates
Last Update Posted: March 26, 2019
Last Verified: March 2019
Keywords provided by Incyte Corporation:
Hair loss
alopecia areata
alopecia totalis
alopecia universalis
JAK inhibitors
topical hair growth
Additional relevant MeSH terms:
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Alopecia
Alopecia Areata
Hypotrichosis
Hair Diseases
Skin Diseases
Pathological Conditions, Anatomical