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

NCT05635838 | Completed Phase 2 Results FDA Drug

• 1 other identifier: INCB 18424-221
• Study Type: interventional
• Target: 69
• Locations: 2 countries
• Sites: 20

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

Keywords

Hidradenitis suppurativa; skin disease; ruxolitinb cream

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (10)

• Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16

  Baseline; Week 16

• Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline

  Baseline; Week 16

• Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16

  Baseline; Week 16

• Change From Baseline in Itch NRS Score at Week 16

  Baseline; Week 16

• Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16

  Baseline; Week 16

Study Arms (2)

Ruxolitinib Cream

EXPERIMENTAL

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

Vehicle Cream

EXPERIMENTAL

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

Interventions

Ruxolitinib cream DRUG

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

Also known as: INCB018424 cream

Ruxolitinib Cream

Vehicle cream DRUG

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

Vehicle Cream

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Presence of draining tunnels at screening or at baseline visits.
• Concurrent conditions and history of other diseases:
• Active ongoing inflammatory diseases of the skin other than HS that might confound the evaluation of HS.
• 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.
• Immunocompromised (eg, lymphoma, acquired immunodeficiency syndrome, or Wiskott-Aldrich syndrome).
• Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline.
• 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.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (20)

Medical Dermatology Specialists Phoenix

Phoenix, Arizona, 85006, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Skin Care Research, Llc Scr Hollywood

Boca Raton, Florida, 33486, United States

Location

Forcare Clinical Research

Tampa, Florida, 33613, United States

Location

Marietta Dermatology the Skin Cancer Center Marietta

Marietta, Georgia, 30060-1047, United States

Location

Delricht Research

Baton Rouge, Louisiana, 70809, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Revival Research Institute, Llc Troy

Troy, Michigan, 48084, United States

Location

Dr Bobby Buka, Md Greenwich Village

New York, New York, 10012-1354, United States

Location

Dermatology Associates of Plymouth Meeting

Plymouth Meeting, Pennsylvania, 19462, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Pflugerville, Texas, 78660, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Wiseman Dermatology Research Inc

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Dr.Wei Jing Loo Medicine Professional Corp

London, Ontario, N6H 5L4, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X2, Canada

Location

Skin Centre For Dermatology

Peterborough, Ontario, K9J 5K2, Canada

Location

Xlr8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

MeSH Terms

Conditions

Hidradenitis Suppurativa; Skin Diseases

Condition Hierarchy (Ancestors)

Skin Diseases, Bacterial; Bacterial Infections; Bacterial Infections and Mycoses; Infections; Skin Diseases, Infectious; Suppuration; Skin and Connective Tissue Diseases; Hidradenitis; Sweat Gland Diseases

Results Point of Contact

• Title: Study Director
• Organization: Incyte Corporation

medinfo@incyte.com

1-855-463-3463

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR
• Expanded Access: Yes

Model Details: Participants will be randomized 1:1 to 1 of 2 treatment groups (ruxolitinib 1.5% cream BID or vehicle cream BID).

Study Record Dates

• First Submitted: November 23, 2022
• First Posted: December 2, 2022
• Study Start: December 7, 2022
• Primary Completion: October 19, 2023
• Study Completion: March 14, 2024
• Last Updated: November 1, 2024
• Results First Posted: November 1, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
• 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.

Locations

CA (5); US (15)