Alopecia
A Study with Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Incyte Study ID:
INCB 18424-204
CT.gov ID:
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
Results Available
Protocol
Available Languages: English
Statistical Analysis Plan (SAP)
Available Languages: English
Clinical Study Purpose
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.
Clinical Study Summary
MEDICAL CONDITION(S)
PRODUCT
COLLABORATORS
N/A
DATE
Nov 2015 - Oct 2017
TYPE
Interventional
PHASE
Phase 2
SEX
Female & Male
AGE
18 - 70 Years
ACCEPTS HEALTHY VOLUNTEERS
Yes
Clinical Study Locations
Name
Contact UsName
Birmingham, AL, US
Name
Hot Springs, AR, US
Name
New Haven, CT, US
Name
Trumbull, CT, US
Name
Miami, FL, US
Name
Beverly, MA, US
Key Inclusion and Exclusion Criteria
Inclusion Criteria
- Diagnosis of AA
- Duration and extent of current episode of AA
Exclusion Criteria
- Evidence of diffuse, spontaneous terminal hair regrowth
- Receipt of treatment known to potentially affect the course of AA within last month
Protocol Summary
Incyte Study ID:
INCB 18424-204
Primary Purpose:
Treatment
Allocation:
Randomized
Study Design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Interventions:
Drug
Enrollment:
90
Primary Outcome
Open
Percentage of subjects achieving a Severity of Alopecia Tool score (SALT) 50 response in terminal hair (pigmented and nonpigmented) at Week 24
Timeframe: 24 weeks
Secondary Outcome
Open
Mean change from Baseline in SALT score through Week 24
Timeframe: 24 weeks