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
View Results Summary
Eudra ID:
N/A
EU CT Number:
N/A
Sponsor:
Incyte Corporation
Collaborator:
N/A
Study Contact Information:
1.855.463.3463 or [email protected]
Study Complete
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Results Available

Protocol
Available Languages: English
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Statistical Analysis Plan (SAP)
Available Languages: English
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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 - Mar 2024
    TYPE
    Interventional
    PHASE
    Phase 2
    SEX
    Female & Male
    AGE
    18+ years
    ACCEPTS HEALTHY VOLUNTEERS
    No

    Clinical Study Locations

    Name
    Contact Us
    Name
    DR.WEI JING LOO MEDICINE PROFESSIONAL CORP
    LONDON, ON, Canada, N6H 5L4
    Name
    DELRICHT RESEARCH
    BATON ROUGE, LA, US, 70809
    Name
    XLR8 MEDICAL RESEARCH
    WINDSOR, ON, Canada, N8W 1E6
    Name
    WISEMAN DERMATOLOGY RESEARCH INC
    WINNIPEG, MB, Canada, R3M 3Z4
    Name
    LYNDERM RESEARCH INC
    MARKHAM, ON, Canada, L3P 1X2
    Name
    SKIN CENTRE FOR DERMATOLOGY
    PETERBOROUGH, ON, Canada, K9J 5K2
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    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:
    Requirements information
    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:
    • a. A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND
    • b. The AN count at the screening AND baseline visits:
    • − AN of 3 should affect at least 1 distinct anatomical area
    • − AN of > 3 to ≤ 10 should affect at least 2 distinct anatomical areas.
    • Baseline Skin Pain or Itch NRS score ≥ 1.
    • Agreement to NOT use topical and systemic antibiotics for treatment of HS during the study.
    • Agreement to NOT use a diluted beach bath or topical antiseptic washes containing chlorhexidine gluconate or benzoyl peroxide on the areas affected by HS lesions during the study.
    • Willingness to avoid pregnancy or fathering children
    Exclusion Criteria
    • Presence of draining tunnels at screening or at baseline visits.
    • Concurrent conditions and history of other diseases:
    • a. Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.
    • b. Any other concomitant skin disorder (eg, generalized erythroderma such as Netherton's syndrome), pigmentation, or extensive scarring that in the opinion of the investigator may interfere with the evaluation of HS AN or compromise participant safety.
    • c. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
    • d. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
    • e. Active acute bacterial, fungal, or viral skin infection (eg, herpes simplex, herpes zoster, chicken pox, clinically infected AD, or impetigo) within 2 weeks before baseline.
    • Laboratory values outside of the protocol-defined criteria.
    • Use of any prohibited medications per protocol-defined criteria.
    • Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.
    • Other exclusion criteria may apply.

    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: Ruxolitinib cream
  • Drug: Vehicle cream
    • 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