Back to resultsA Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Primary Purpose
Alopecia Areata
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Placebo Cream
Ruxolitinib Phosphate Cream
Sponsored by
About this trial
This is an interventional treatment trial for Alopecia Areata focused on measuring Hair loss, alopecia areata, alopecia totalis, alopecia universalis, JAK inhibitors, topical hair growth
Eligibility 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
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ruxolitinib Phosphate Cream
Placebo Cream
Arm Description
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.
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.
Outcomes
Primary Outcome Measures
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.
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.
Secondary Outcome Measures
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.
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.
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.
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).
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
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).
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
Full Information
NCT ID
NCT02553330
First Posted
September 16, 2015
Last Updated
November 20, 2020
Sponsor
Incyte Corporation
1. Study Identification
Unique Protocol Identification Number
NCT02553330
Brief Title
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
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
Study Type
Interventional
2. Study Status
Record Verification Date
November 2020
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated early based on the results of a planned interim analysis.
Study Start Date
November 18, 2015 (Actual)
Primary Completion Date
October 3, 2017 (Actual)
Study Completion Date
October 3, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alopecia Areata
Keywords
Hair loss, alopecia areata, alopecia totalis, alopecia universalis, JAK inhibitors, topical hair growth
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
90 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib Phosphate Cream
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo Cream
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo Cream
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib Phosphate Cream
Other Intervention Name(s)
INCB018424
Primary Outcome Measure Information:
Title
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Description
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
Title
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)
Description
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 Outcome Measure Information:
Title
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Description
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
Title
Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Description
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
Title
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Description
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.
Title
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
Description
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
Title
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
Description
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.
Title
Part B: Mean Change From Baseline in SALT Score
Description
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.
Title
Part A and B : Number of Treatment-emergent Adverse Events
Description
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Kathleen Butler, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
City
Birmingham
State/Province
Alabama
Country
United States
City
Hot Springs
State/Province
Arkansas
Country
United States
City
New Haven
State/Province
Connecticut
Country
United States
City
Trumbull
State/Province
Connecticut
Country
United States
City
Miami
State/Province
Florida
Country
United States
City
Beverly
State/Province
Massachusetts
Country
United States
City
Boston
State/Province
Massachusetts
Country
United States
City
Clinton Township
State/Province
Michigan
Country
United States
City
Fort Gratiot
State/Province
Michigan
Country
United States
City
Fridley
State/Province
Minnesota
Country
United States
City
Minneapolis
State/Province
Minnesota
Country
United States
City
Winston-Salem
State/Province
North Carolina
Country
United States
City
Cleveland
State/Province
Ohio
Country
United States
City
Portland
State/Province
Oregon
Country
United States
City
Austin
State/Province
Texas
Country
United States
City
Houston
State/Province
Texas
Country
United States
City
Katy
State/Province
Texas
Country
United States
City
Norfolk
State/Province
Virginia
Country
United States
12. IPD Sharing Statement
Citations:
PubMed Identifier
28619556
Citation
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.
Results Reference
derived
Learn more about this trial
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
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