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

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

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.

Study Overview

• Status: Terminated
• Conditions: Alopecia Areata
• Intervention / Treatment: Drug: Placebo Cream; Drug: Ruxolitinib Phosphate Cream

• Study Type: Interventional
• Enrollment (Actual): 90
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States
  • Arkansas
    • Hot Springs, Arkansas, United States
  • Connecticut
    • New Haven, Connecticut, United States
    • Trumbull, Connecticut, United States
  • Florida
    • Miami, Florida, United States
  • Massachusetts
    • Beverly, Massachusetts, United States
    • Boston, Massachusetts, United States
  • Michigan
    • Clinton Township, Michigan, United States
    • Fort Gratiot, Michigan, United States
  • Minnesota
    • Fridley, Minnesota, United States
    • Minneapolis, Minnesota, United States
  • North Carolina
    • Winston-Salem, North Carolina, United States
  • Ohio
    • Cleveland, Ohio, United States
  • Oregon
    • Portland, Oregon, United States
  • Texas
    • Austin, Texas, United States
    • Houston, Texas, United States
    • Katy, Texas, United States
  • Virginia
    • Norfolk, Virginia, United States

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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 Names: 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 Names: INCB018424

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.	Up to Week 24
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)	Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.	Week 24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.	Up to Week 24
Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.	Week 24
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.	Number of participants achieving 90% or greater improvement in their SALT score (SALT90) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.	Weeks 4, 8, 12, 18, and 24.
Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3	Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, <25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).	Baseline to Week 24
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).	Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes	Weeks 4, 8, 12, and 18.
Part B: Mean Change From Baseline in SALT Score	Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).	Weeks 4, 8, 12, 18, and 24.
Part A and B : Number of Treatment-emergent Adverse Events	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment	Up to 100 weeks

Collaborators and Investigators

• Sponsor: Incyte Corporation

Publications and helpful links

General Publications

• Bayart CB, DeNiro KL, Brichta L, Craiglow BG, Sidbury R. Topical Janus kinase inhibitors for the treatment of pediatric alopecia areata. J Am Acad Dermatol. 2017 Jul;77(1):167-170. doi: 10.1016/j.jaad.2017.03.024. No abstract available.

Study record dates

Study Major Dates

• Study Start (Actual): November 18, 2015
• Primary Completion (Actual): October 3, 2017
• Study Completion (Actual): October 3, 2017

Study Registration Dates

• First Submitted: September 16, 2015
• First Submitted That Met QC Criteria: September 16, 2015
• First Posted (Estimate): September 17, 2015

Study Record Updates

• Last Update Posted (Actual): December 16, 2020
• Last Update Submitted That Met QC Criteria: November 20, 2020
• Last Verified: November 1, 2020

More Information

Terms related to this study

• Keywords: JAK inhibitors; Hair loss; alopecia totalis; alopecia universalis; alopecia areata; topical hair growth
• Additional Relevant MeSH Terms: Skin Diseases; Pathological Conditions, Anatomical; Hypotrichosis; Hair Diseases; Alopecia; Alopecia Areata
• Other Study ID Numbers: INCB 18424-204