Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

NCT05219864 | Withdrawn Phase 3 FDA Drug

• 1 other identifier: INCB 18424-313
• Study Type: interventional
• Target: N/A
• Locations: 6 countries
• Sites: 49

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

Hand Eczema

Keywords

eczema; chronic hand eczema (CHE); dermatitis; skin disease; JAK inhibitor

Outcome Measures

Primary Outcomes (1)

• Proportion 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 (14)

• Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score

  Week 16

• Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score

  Week 16

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

  Up to Week 32

• Proportion of participants achieving an IGA-CHE-TS from baseline

  Up to Week 32

• Change from baseline in CHE-related Itch Numerical Rating Scale (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 (49)

Southwest Skin Specialists Phoenix Biltmore

Phoenix, Arizona, 85018, United States

Location

Raoof Md Encino

Encino, California, 91436, United States

Location

First Oc Dermatology

Fountain Valley, California, 92708, United States

Location

Marvel Clinical Research Llc

Huntington Beach, California, 92647, United States

Location

Well Pharma Medical Research Corporation

Miami, Florida, 33173, United States

Location

Psoriasis Treatment Center of South Florida

Pembroke Pines, Florida, 33028, United States

Location

Lenus Research Medical Group, Llc

Sweetwater, Florida, 33172, United States

Location

Delricht Research

Marietta, Georgia, 30060, United States

Location

Arlington Dermatology

Rolling Meadows, Illinois, 60008, United States

Location

Midwest Allergy Sinus Asthma, Sc

Springfield, Illinois, 62604, United States

Location

Dermatologist Specialist

Louisville, Kentucky, 40241, United States

Location

Grafton Dermatology and Cosmetic Surgery

Houma, Louisiana, 70364, United States

Location

Delricht Research

New Orleans, Louisiana, 70115, United States

Location

Washington University

St Louis, Missouri, 63110, United States

Location

Jubilee Clinical Research Inc

Las Vegas, Nevada, 89106, United States

Location

Juva Skin and Laser Center

New York, New York, 10022, United States

Location

Oregon Medical Research Center

Portland, Oregon, 97223, United States

Location

Oregon Health & Science University

Portland, Oregon, 97239, United States

Location

Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center

Memphis, Tennessee, 38119, United States

Location

International Clinical Research Tennessee Llc

Murfreesboro, Tennessee, 37130, United States

Location

Austin Institute For Clinical Research Aicr Pflugerville

Houston, Texas, 77056, United States

Location

Progressive Clinical Research

San Antonio, Texas, 78213, United States

Location

Center For Clinical Studies Webster

Webster, Texas, 77598, United States

Location

University of Utah

Murray, Utah, 84107, United States

Location

West End Dermatology Associates

Richmond, Virginia, 23233, United States

Location

Dermatology Specialists of Spokane

Spokane, Washington, 99202, United States

Location

Dermatology Research Institute Inc.

Calgary, Alberta, T2J 7E1, Canada

Location

Care Clinic

Red Deer, Alberta, T4P-1K4, Canada

Location

Cca Medical Research

Ajax, Ontario, L1S 7K8, Canada

Location

Lynderm Research Inc

Markham, Ontario, L3P 1X3, Canada

Location

Fakultni Nemocnice U Sv. Anny V Brne

Brno, 656 91, Czechia

Location

Ccr Ostrava S.R.O.

Ostrava, 702 00, Czechia

Location

Ccr Czech A.S.

Pardubice, 53000, Czechia

Location

Clintrial S.R.O.

Prague, 100 00, Czechia

Location

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

Ústí nad Labem, 401 13, Czechia

Location

Klinikum Der Johann Wolfgang Goethe-Universitaet

Frankfurt, 60590, Germany

Location

Derma-Study-Center Friedrichshafen Gmbh

Friedrichshafen, 88045, Germany

Location

Dermatologikum Hamburg Gemeinschaftspraxis Gbr

Hamburg, 20354, Germany

Location

Universitaetsklinikum Schleswig-Holstein

Kiel, 24105, Germany

Location

Praxis Dr. Beate Schwarz

Langenau, 89129, Germany

Location

Beldio Research Gmbh

Memmingen, 87700, Germany

Location

Klifos - Klinische Forschung Osnabruck

Osnabrück, 49074, Germany

Location

Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.

Elblag, 82-300, Poland

Location

Etg Warszawa

Warsaw, 02-793, Poland

Location

Hospital General Universitario de Alicante

Alicante, 03010, Spain

Location

Hospital de La Santa Creu I Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Maranon

Madrid, 28007, Spain

Location

Hospital de Manises

Manises, 46940, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, 28223, 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: January 21, 2022
• First Posted: February 2, 2022
• Study Start: January 31, 2023
• Primary Completion: April 25, 2024
• Study Completion: September 22, 2024
• Last Updated: November 17, 2022

Record last verified: 2022-11

Data Sharing

• IPD Sharing: Will not share

Locations

CZ (5); US (26); DE (7); PL (2); CA (4); ES (5)