Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2

NCT05233410 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: INCB 18424-314
• Study Type: interventional
• Target: N/A
• Locations: 7 countries
• Sites: 39

Brief Summary

The purpose of this study is to evaluate the efficacy and safety of ruxolitinib cream in adult participants with diagnosis of chronic hand eczema (CHE) and moderate to severe disease activity (Investigator's Global Assessement (IGA) of CHE score 3 or 4).

Conditions

Chronic Hand Eczema (CHE)

Keywords

eczema; hand eczema; dermatitis; skin disease; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)

  The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is an instrument used in clinical trials to rate the severity of the participant's global chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline.

  Week 16

Secondary Outcomes (20)

• Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score

  Baseline to Week 16

• Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score

  Baseline to Week 16

• Change from baseline in the mTLSS (modified Total Lesion Symptom Score

  Up to Week 32

• Percentage of Participants achieving an IGA CHE-TS

  Up to Week 32

• Change from baseline in CHE-related Itch NRS score (weekly average)

  Up to Week 32

Study Arms (2)

Ruxolitinib

EXPERIMENTAL

Ruxolitinib cream 1.5% twice daily (BID) for 16 weeks followed by ruxolitinib cream 1.5% BID for an additional 16-week treatment extension period.

Drug: Ruxolitinib cream

Vehicle

PLACEBO COMPARATOR

Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.

Drug: Vehicle

Interventions

Ruxolitinib cream DRUG

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

Also known as: INCB18424 cream

Ruxolitinib

Vehicle DRUG

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

Vehicle

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Diagnosis of chromic hand eczema (CHE) as defined by hand eczema (HE) lasting \> 3 months or ≥ 2 flares within the previous 12 months.
• Screening and baseline IGA-CHE 3 or 4.
• Baseline CHE-related Itch NRS ≥ 4.
• Recent history (within the past 1 year of baseline) of inadequate response to treatment with topical corticosteroids (TCS), topical calcineurin inhibitors (TCI), or oral alitretinoin; or intolerance or contraindication to TCS or TCI or oral alitretinoin.
• Willingness to avoid pregnancy or fathering children based on the criteria below.

You may not qualify if:

• Known triggers for CHE (allergic or irritant, such as those identified by previous patch tests) cannot be avoided during the course of this study.
• Participants who have an unstable course of AD (spontaneously improving or rapidly deteriorating) as determined by the investigator in the 4 weeks prior to baseline.
• Participants with concurrent conditions and history of other diseases such as other active skin disease or infection on the hands; immunocompromised; chronic or acute infection requiring systemic treatments; active acute skin infection; other concomitant skin conditions that may interfere with study assessments or compromise participant safety; other types of eczema; chronic asthma requiring high dose of inhaled corticosteroids; current or history of hepatitis B or C virus infection.
• Any serious illness or medical, physical, or psychiatric condition(s) that, in the investigator's opinion, would interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.
• Laboratory values outside of the protocol-defined criteria.
• Use of protocol-defined treatments within the indicated washout period before baseline.
• Psoralen ultraviolet A (PUVA) or ultraviolet B (UVB) therapy on the hands within 4 weeks before baseline.
• Pregnant or lactating participants, or those considering pregnancy during the period of their study participation.

Sponsors & Collaborators

• Incyte Corporation: lead

Study Sites (39)

University of Alabama Hospital

Birmingham, Alabama, 35249, United States

Location

Marvel Clinical Research LLC

Huntington Beach, California, 92647, United States

Location

Advanced RX Clin Research

Westminster, California, 92683, United States

Location

Advanced Rx Clinical Research

Westminster, California, 92683, United States

Location

Forcare Clinical Research

Tampa, Florida, 33613, United States

Location

Midwest Allergy Sinus Asthma, Sc

Springfield, Illinois, 62704, United States

Location

The Indiana Clinical Trials Center Ictc

Plainfield, Indiana, 46168, United States

Location

Delricht Research

Baton Rouge, Louisiana, 70809, United States

Location

Jubilee

Las Vegas, Nevada, 89106, United States

Location

Onsite Clinical Solutions, Llc Charlotte Central Office

Charlotte, North Carolina, 28277, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Froedtert & Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Medical Center Unimed Eood

Sevlievo, 05402, Bulgaria

Location

Dcc 'Alexandrovska', Eood

Sofia, 01431, Bulgaria

Location

Medical Center Hera Eood

Sofia, 01510, Bulgaria

Location

Dcc Xxviii

Sofia, 01592, Bulgaria

Location

Mc 'Synexus - Sofia', Eood

Sofia, 01784, Bulgaria

Location

Dcc 'Alexandrovska', Eood

Sofia, 1431, Bulgaria

Location

Dr. Chih-Ho Hong Medical Inc.

Surrey, British Columbia, V3R 6A7, Canada

Location

Simcomed Health Ltd

Barrie, Ontario, L4M 1G7, Canada

Location

Xlr8 Medical Research

Windsor, Ontario, N8W 1E6, Canada

Location

Fakultni Nemocnice U Sv. Anny V Brne

Brno, 656 91, Czechia

Location

Clintrial SRO

Prague, 100 00, Czechia

Location

Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.

Ústí nad Labem, 401 13, Czechia

Location

Charite Universitaetsmedizin Berlin - Campus Charite Mitte

Berlin, 10117, Germany

Location

Universitaetsklinikum Frankfurt

Frankfurt, 60590, Germany

Location

Derma-Study-Center Friedrichshafen Gmbh

Friedrichshafen, 88045, Germany

Location

Dermatologikum Hamburg Gemeinschaftspraxis Gbr

Hamburg, 20354, Germany

Location

Universitaetsklinikum Schleswig Holstein - Campus Luebeck

Lübeck, 23538, Germany

Location

Gemeinschaftspraxis

Mahlow, 15381, Germany

Location

Beldio Research Gmbh

Memmingen, 87700, Germany

Location

Dermatologische Klinik Der Technischen Universitat Munchen

München, 80802, Germany

Location

Klifos - Klinische Forschung Osnabrück

Osnabrück, 49074, Germany

Location

Etg Warszawa

Warsaw, 02-777, Poland

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Clinica Dermomedic

Madrid, 28001, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28007, Spain

Location

Hospital Universitario Quironsalud Madrid

Madrid, 28223, Spain

Location

Hospital de Manises

Valencia, 46940, Spain

Location

MeSH Terms

Conditions

Eczema; Dermatitis; Skin Diseases

Condition Hierarchy (Ancestors)

Skin and Connective Tissue Diseases; Skin Diseases, Eczematous

Study Officials

• Haq Nawaz, MD

  Incyte Corporation

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Participants will receive ruxolitinib cream (1.5%) or vehicle cream for 16 weeks, after which they will be offered the opportunity to receive ruxilitinib cream (1.5%) in the open-label treatment extension period for another 16 weeks.

Study Record Dates

• First Submitted: February 1, 2022
• First Posted: February 10, 2022
• Study Start: January 31, 2023
• Primary Completion: April 25, 2024
• Study Completion: September 22, 2024
• Last Updated: November 10, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CA (3); CZ (3); DE (9); US (12); PL (1); ES (5); BU (6)