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

NCT ID: NCT05635838

Last Updated: 2024-11-01

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 69 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-12-07
• Study Completion Date: 2024-03-14

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.

Conditions

Hidradenitis Suppurativa

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: QUADRUPLE

Study Groups

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.

Group Type: EXPERIMENTAL

Ruxolitinib cream

Intervention Type: DRUG

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

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.

Group Type: EXPERIMENTAL

Vehicle cream

Intervention Type: DRUG

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

Interventions

Ruxolitinib cream

Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.

Intervention Type: DRUG

Vehicle cream

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

Intervention Type: DRUG

Other Intervention Names

INCB018424 cream

Eligibility 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:

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Incyte Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, United States

First Oc Dermatology

Fountain Valley, California, United States

Skin Care Research, Llc Scr Hollywood

Boca Raton, Florida, United States

Forcare Clinical Research

Tampa, Florida, United States

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, United States

Delricht Research

Baton Rouge, Louisiana, United States

Delricht Research

New Orleans, Louisiana, United States

Beth Israel Deaconess Medical Center

Boston, Massachusetts, United States

Revival Research Institute, Llc Troy

Troy, Michigan, United States

Dr Bobby Buka, Md Greenwich Village

New York, New York, United States

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, United States

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, United States

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, United States

Progressive Clinical Research

San Antonio, Texas, United States

Dermatology Specialists of Spokane

Spokane, Washington, United States

Wiseman Dermatology Research Inc

Winnipeg, Manitoba, Canada

Dr.Wei Jing Loo Medicine Professional Corp

London, Ontario, Canada

Lynderm Research Inc

Markham, Ontario, Canada

Skin Centre For Dermatology

Peterborough, Ontario, Canada

Xlr8 Medical Research

Windsor, Ontario, Canada

Countries

United States; Canada

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

INCB 18424-221

Identifier Type: -

Identifier Source: org_study_id