Clinical trial NCT02553330: 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
Overall status: TERMINATED
Phase: PHASE2
Conditions: Alopecia Areata
Keywords: Hair loss
alopecia areata
alopecia totalis
alopecia universalis
JAK inhibitors
topical hair growth
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2015-09-17
Enrollment: 90
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
timeFrame: Up to Week 24
measure: Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)
timeFrame: Week 24
Secondary outcomes:
measure: Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
timeFrame: Up to Week 24
measure: Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
timeFrame: Week 24
measure: Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
timeFrame: Weeks 4, 8, 12, 18, and 24.
measure: 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
timeFrame: Baseline to Week 24
measure: Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
timeFrame: Weeks 4, 8, 12, and 18.
measure: Part B: Mean Change From Baseline in SALT Score
timeFrame: Weeks 4, 8, 12, 18, and 24.
measure: Part A and B : Number of Treatment-emergent Adverse Events
timeFrame: Up to 100 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
state: Alabama
city: Hot Springs
country: United States
state: Arkansas
city: New Haven
country: United States
state: Connecticut
city: Trumbull
country: United States
state: Connecticut
city: Miami
country: United States
state: Florida
city: Beverly
country: United States
state: Massachusetts
city: Boston
country: United States
state: Massachusetts
city: Clinton Township
country: United States
state: Michigan
city: Fort Gratiot
country: United States
state: Michigan
city: Fridley
country: United States
state: Minnesota
city: Minneapolis
country: United States
state: Minnesota
city: Winston-Salem
country: United States
state: North Carolina
city: Cleveland
country: United States
state: Ohio
city: Portland
country: United States
state: Oregon
city: Austin
country: United States
state: Texas
city: Houston
country: United States
state: Texas
city: Katy
country: United States
state: Texas
city: Norfolk
country: United States
state: Virginia
Study officials:
affiliation: Incyte Corporation
name: Kathleen Butler, MD
role: STUDY_DIRECTOR
References:
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.