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 Contact: Name: Incyte Corporation Call Center (US); Phone Number: 1.855.463.3463; Email: medinfo@incyte.com
• Study Contact Backup: Name: Incyte Corporation Call Center (ex-US); Phone Number: +800 00027423; Email: eumedinfo@incyte.com

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: 16 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 nodules (AN) count at Week 16.	Defined as total count of abscess and inflammatory nodules.	Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants achieving AN50	Defined as at least 50% reduction respectively in AN count relative to baseline.	Week 16
Proportion of participants achieving AN75	Defined as at least 75% reduction respectively in AN count relative to baseline.	Week 16
Proportion of participants achieving AN90	Defined as at least 90% reduction respectively in AN count relative to baseline.	Week 16
Proportion of participants achieving AN100	Defined as 100% reduction respectively in AN count relative to baseline.	Week 16
Change from baseline in the Skin Pain Numeric Rating Scale (NRS)	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.	Week 16
Change from baseline in the Itch NRS score	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.	Week 16
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response (HiSCR)	HiSCR is defined as at least 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to baseline.	Week 16
Change from baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) score	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).	Week 16
Number of Treatment Emergent Adverse Events (TEAEs)	Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment.	Up to 40 weeks

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 (Actual): March 21, 2024
• Last Update Submitted That Met QC Criteria: March 19, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Keywords: skin disease; Hidradenitis suppurativa; ruxolitinb cream
• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Infections; Bacterial Infections; Bacterial Infections and Mycoses; Skin Diseases, Infectious; Suppuration; Skin Diseases, Bacterial; 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