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

Sponsor
Incyte Corporation (Industry)
Overall Status
Recruiting
CT.gov ID
NCT05635838
Collaborator
(none)
60
Enrollment
27
Locations
2
Arms
15.6
Anticipated Duration (Months)
2.2
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Ruxolitinib cream
  • Drug: Vehicle cream
 Phase 2

Study Design

Study Type:
Interventional
Anticipated Enrollment :
60 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Actual Study Start Date :
Dec 7, 2022
Anticipated Primary Completion Date :
Dec 3, 2023
Anticipated Study Completion Date :
Mar 25, 2024

Arms and Interventions

Arm Intervention/Treatment
Experimental: Ruxolitinib Cream

Ruxolitinib 1.5% cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

Drug: Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Other Names:
  • INCB018424 cream

    		•
    Experimental: Vehicle Cream

    Vehicle cream BID for 16 weeks of double-blind, vehicle-controlled (DBVC) period followed by ruxolitinb 1.5% cream BID for 16 weeks in an open-label extension.

    Drug: Vehicle cream
    Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.

    Outcome Measures

    Primary Outcome Measures

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

      Defined as total count of abscess and inflammatory nodules.

    Secondary Outcome Measures

    1. Proportion of participants achieving AN50 [Week 16]

      Defined as at least 50% reduction respectively in AN count relative to baseline.

    2. Proportion of participants achieving AN75 [Week 16]

      Defined as at least 75% reduction respectively in AN count relative to baseline.

    3. Proportion of participants achieving AN90 [Week 16]

      Defined as at least 90% reduction respectively in AN count relative to baseline.

    4. Proportion of participants achieving AN100 [Week 16]

      Defined as 100% reduction respectively in AN count relative to baseline.

    5. Change from baseline in the Skin Pain Numeric Rating Scale (NRS) [Week 16]

      Defined as skin pain severity on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) in the past 24 hours.

    6. Change from baseline in the Itch NRS score [Week 16]

      The Itch NRS is defined as itch severity on an 11-point scale ranging from 0 (no itch) to 10 (worst imaginable itch) in the past 24 hours.

    7. Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR) [Week 16]

      HiSCR is defined as at least 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to baseline.

    8. Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score [Week 16]

      IHS4 score is calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4).

    9. Number of Treatment Emergent Adverse Events (TEAEs) [Up to 40 weeks]

      Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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:

    1. A total AN count of 3 to ≤ 10, with no draining tunnels at screening and baseline visits. AND

    2. 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:

    1. Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.

    2. 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.

    3. Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).

    4. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.

    5. 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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Medical Dermatology Specialists Phoenix Phoenix Arizona United States 85006
    2 First Oc Dermatology Fountain Valley California United States 92708
    3 Skin Care Research, Llc Scr Hollywood Boca Raton Florida United States 33486
    4 Forcare Clinical Research Tampa Florida United States 33613
    5 Marietta Dermatology the Skin Cancer Center Marietta Marietta Georgia United States 30060-1047
    6 Delricht Research Baton Rouge Louisiana United States 70809
    7 Delricht Research Baton Rouge Louisiana United States 70809
    8 Delricht Research New Orleans Louisiana United States 70115
    9 Beth Israel Deaconess Medical Center Boston Massachusetts United States 02215
    10 Revival Research Institute, Llc Troy Troy Michigan United States 48084
    11 Dr Bobby Buka, Md Greenwich Village New York New York United States 10012-1354
    12 Dermatology Associates of Plymouth Meeting Plymouth Meeting Pennsylvania United States 19462
    13 International Clinical Research Tennessee Llc Murfreesboro Tennessee United States 37130
    14 Austin Institute For Clinical Research Aicr Pflugerville Pflugerville Texas United States 78660
    15 Progressive Clinical Research San Antonio Texas United States 78213
    16 Dermatology Specialists of Spokane Spokane Washington United States 99202
    17 Wiseman Dermatology Research Inc Winnipeg Manitoba Canada R3M 3Z4
    18 Dr.Wei Jing Loo Medicine Professional Corp London Ontario Canada N6H 5L4
    19 Dr.Wei Jing Loo Medicine Professional Corp London Ontario Canada N6H 5L5
    20 Lynderm Research Inc Markham Ontario Canada L3P 1X2
    21 Skin Centre For Dermatology Peterborough Ontario Canada K9J 5K2
    22 Xlr8 Medical Research Windsor Ontario Canada N8W 1E6
    23 Centrum Medyczne Pratia Katowice I Katowice Poland 40-081
    24 Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O. Malbork Poland 82-200
    25 Niepubliczny Zaklad Opieki Zdrowotnej Agnieszka Owczarczyk Saczonek Sp K Poradnia Dermatologiczna Olsztyn Poland 10-226
    26 Laser Clinic S.C. Dr Tomasz Kochanowski Dr Andrzej Krolicki Szczecin Poland 70-332
    27 Royalderm Warszawa Poland 02-962

    Sponsors and Collaborators

    • Incyte Corporation

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Incyte Corporation
    ClinicalTrials.gov Identifier:
    NCT05635838
    Other Study ID Numbers:
    • INCB 18424-221
    First Posted:
    Dec 2, 2022
    Last Update Posted:
    Dec 15, 2022
    Last Verified:
    Dec 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Incyte Corporation
    Hidradenitis suppurativa
    skin disease
    ruxolitinb cream
    Additional relevant MeSH terms:
    Hidradenitis Suppurativa
    Hidradenitis

    Study Results

    No Results Posted as of Dec 15, 2022