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

A Phase 2, Double-Blind, Randomized, Vehicle-Controlled, Efficacy, and Safety Study of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa

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.

Study Overview

• Status: Completed
• Conditions: Hidradenitis Suppurativa
• Intervention / Treatment: Drug: Ruxolitinib cream; Drug: Vehicle cream

• Study Type: Interventional
• Enrollment (Actual): 69
• Phase: Phase 2

Expanded Access

Approved for sale to the public. See expanded access record.

Contacts and Locations

Study Locations

• Canada
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Wiseman Dermatology Research Inc
  • Ontario
    • London, Ontario, Canada, N6H 5L4
      • Dr.Wei Jing Loo Medicine Professional Corp
    • Markham, Ontario, Canada, L3P 1X2
      • Lynderm Research Inc
    • Peterborough, Ontario, Canada, K9J 5K2
      • Skin Centre For Dermatology
    • Windsor, Ontario, Canada, N8W 1E6
      • XLR8 Medical Research
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85006
      • Medical Dermatology Specialists Phoenix
  • California
    • Fountain Valley, California, United States, 92708
      • First Oc Dermatology
  • Florida
    • Boca Raton, Florida, United States, 33486
      • Skin Care Research, Llc Scr Hollywood
    • Tampa, Florida, United States, 33613
      • ForCare Clinical Research
  • Georgia
    • Marietta, Georgia, United States, 30060-1047
      • Marietta Dermatology the Skin Cancer Center Marietta
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Massachusetts
    • Boston, Massachusetts, United States, 02215
      • Beth Israel Deaconess Medical Center
  • Michigan
    • Troy, Michigan, United States, 48084
      • Revival Research Institute, Llc Troy
  • New York
    • New York, New York, United States, 10012-1354
      • Dr Bobby Buka, Md Greenwich Village
  • Pennsylvania
    • Plymouth Meeting, Pennsylvania, United States, 19462
      • Dermatology Associates of Plymouth Meeting
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Pflugerville, Texas, United States, 78660
      • Austin Institute For Clinical Research Aicr Pflugerville
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 14 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16	The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.	Baseline; Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16	AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline.	Baseline; Week 16
Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline	Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.	Baseline; Week 16
Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16	The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.	Baseline; Week 16
Change From Baseline in Itch NRS Score at Week 16	The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.	Baseline; Week 16
Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16	HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline.	Baseline; Week 16
Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16	The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was 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). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.	Baseline; Week 16
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period	An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.	up to Week 16 plus 30 days
Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.	up to Week 16 plus 30 days
Number of Participants With Any TEAE in the Open-label Extension (OLE) Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.	from Week 17 up to Week 32 plus 30 days
Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period	An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.	from Week 17 up to Week 32 plus 30 days

Collaborators and Investigators

• Sponsor: Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Actual): December 7, 2022
• Primary Completion (Actual): October 19, 2023
• Study Completion (Actual): March 14, 2024

Study Registration Dates

• First Submitted: November 23, 2022
• First Submitted That Met QC Criteria: November 23, 2022
• First Posted (Actual): December 2, 2022

Study Record Updates

• Last Update Posted (Estimated): November 1, 2024
• Last Update Submitted That Met QC Criteria: October 30, 2024
• Last Verified: October 1, 2024

More Information

Terms related to this study

• Keywords: skin disease; Hidradenitis suppurativa; ruxolitinb cream
• Additional Relevant MeSH Terms: Infections; Skin Diseases; Bacterial Infections; Bacterial Infections and Mycoses; Sweat Gland Diseases; Skin Diseases, Bacterial; Skin Diseases, Infectious; Suppuration; Hidradenitis Suppurativa; Hidradenitis
• Other Study ID Numbers: INCB 18424-221

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
• IPD Sharing Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• IPD Sharing Access Criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No