Acne Inversa

Study to evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

Incyte Study ID:
INCB 18424-221
CT.gov ID:
NCT05635838
Eudra ID:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Clinical Study Purpose

The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants with Hidradenitis Suppurativa. This is a randomized 16-week double-blind, vehicle-controlled (DBVC) study followed by a 16 week open label extension period (OLE) with an active treatment for participants who complete the DBVC period.

Clinical Study Summary

MEDICAL CONDITION(S)
  • Acne Inversa
    • PRODUCT
  • Drug: Ruxolitinib cream
  • Drug: Vehicle cream
    • COLLABORATORS
    N/A
    DATE
    Dec 2022 - Oct 2023
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Key Inclusion and Exclusion Criteria

    Inclusion Criteria

    • Diagnosis of HS based on clinical history and physical examination for at least 3 months.
    • Diagnosis of HS (Hurley I or II) with the following:

    Exclusion Criteria

    • Presence of draining tunnels at screening or at baseline visits.
    • Concurrent conditions and history of other diseases:

    Clinical Study Locations

    Location
    Status
    Location
    DR.WEI JING LOO MEDICINE PROFESSIONAL CORP
    LONDON, ON, Canada, N6H 5L4
    Status
    Recruiting
    Location
    DELRICHT RESEARCH
    BATON ROUGE, LA, US, 70809
    Status
    Recruiting
    Location
    XLR8 MEDICAL RESEARCH
    WINDSOR, ON, Canada, N8W 1E6
    Status
    Recruiting
    Location
    WISEMAN DERMATOLOGY RESEARCH INC
    WINNIPEG, MB, Canada, R3M 3Z4
    Status
    Recruiting
    Location
    LYNDERM RESEARCH INC
    MARKHAM, ON, Canada, L3P 1X2
    Status
    Recruiting
    Location
    SKIN CENTRE FOR DERMATOLOGY
    PETERBOROUGH, ON, Canada, K9J 5K2
    Status
    Recruiting

    Protocol Summary

    Incyte Study ID:
    INCB 18424-221
    Primary Purpose:
    Treatment
    Allocation:
    Randomized
    Study Design:
    Parallel Assignment
    Masking:
    Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
    Interventions:
    Drug
    Enrollment:
    69
    Primary Outcome
    Open

    Change from baseline in abscess and inflammatory nodules (AN) count at Week 16.

    Timeframe: Week 16

    Secondary Outcome
    Open

    Proportion of participants achieving AN50

    Timeframe: Week 16

    Proportion of participants achieving AN75

    Timeframe: Week 16

    Proportion of participants achieving AN90

    Timeframe: Week 16

    Proportion of participants achieving AN100

    Timeframe: Week 16

    Change from baseline in the Skin Pain Numeric Rating Scale (NRS)

    Timeframe: Week 16

    Change from baseline in the Itch NRS score

    Timeframe: Week 16

    Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)

    Timeframe: Week 16

    Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score

    Timeframe: Week 16

    Number of Treatment Emergent Adverse Events (TEAEs)

    Timeframe: Up to 40 weeks