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

Phase 2TerminatedNCT02553330

Incyte Corporation90 enrolled

Overview

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Alopecia Areata

Interventions

Placebo CreamDRUG

Ruxolitinib Phosphate CreamDRUG

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 YearsHealthy volunteers:

Medical Language ↔ Plain English

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

Locations (18)

Unnamed facility

Birmingham, Alabama, United States

Unnamed facility

Hot Springs, Arkansas, United States

Unnamed facility

New Haven, Connecticut, United States

Outcomes

Primary Outcomes

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.

Time frame: 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.

Time frame: Week 24

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Weeks 4, 8, 12, 18, and 24.

Data from ClinicalTrials.gov

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Unnamed facility

Trumbull, Connecticut, United States

Unnamed facility

Miami, Florida, United States

Unnamed facility

Beverly, Massachusetts, United States

Unnamed facility

Boston, Massachusetts, United States

Unnamed facility

Clinton Township, Michigan, United States

Unnamed facility

Fort Gratiot, Michigan, United States

Unnamed facility

Fridley, Minnesota, United States

...and 8 more locations

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).

Time frame: 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

Time frame: 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).

Time frame: 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

Time frame: Up to 100 weeks