Alopecia

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

Incyte Study ID:
INCB 18424-204
CT.gov ID:
NCT02553330
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463
Other
Subscribe to UpdatesContact Us

Results Available

Protocol
Available Languages: English
Download document(s)
Statistical Analysis Plan (SAP)
Available Languages: English
Download document(s)

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)
  • Alopecia
    • PRODUCT
  • Drug: Placebo Cream
  • Drug: Ruxolitinib Phosphate Cream
    • 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 Us
    Name
    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
    Go to page

    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
    Requirements information
    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

    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: Placebo Cream
  • Drug: Ruxolitinib Phosphate Cream
    • 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