Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1)

Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1 (TRuE-CHE1): A Phase 3, Double-Blind, Randomized, 16-Week, Vehicle-Controlled, Efficacy and Safety Study of Ruxolitinib Cream Followed by an Open-Label Extension Period in Adults With Chronic Hand Eczema

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).

Study Overview

• Status: Withdrawn
• Conditions: Hand Eczema
• Intervention / Treatment: Drug: Ruxolitinib cream; Drug: Vehicle

• Study Type: Interventional
• Phase: Phase 3

Contacts and Locations

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Dermatology Research Institute Inc.
    • Red Deer, Alberta, Canada, T4P-1K4
      • Care Clinic
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • CCA Medical Research
    • Markham, Ontario, Canada, L3P 1X3
      • Lynderm Research Inc
• Czechia
  • Brno, Czechia, 656 91
    • Fakultni nemocnice u sv. Anny v Brne
  • Ostrava, Czechia, 702 00
    • CCR Ostrava s.r.o.
  • Pardubice, Czechia, 53000
    • CCR Czech a.s.
  • Praha 10, Czechia, 100 00
    • CLINTRIAL s.r.o.
  • Usti Nad Labem, Czechia, 401 13
    • Krajska zdravotni a.s. - Masarykova nemocnice v Usti nad Labem o.z.
• Germany
  • Frankfurt, Germany, 60590
    • Klinikum der Johann Wolfgang Goethe-Universitaet
  • Friedrichshafen, Germany, 88045
    • Derma-Study-Center Friedrichshafen GmbH
  • Hamburg, Germany, 20354
    • Dermatologikum Hamburg Gemeinschaftspraxis Gbr
  • Kiel, Germany, 24105
    • Universitaetsklinikum Schleswig-Holstein
  • Langenau, Germany, 89129
    • Praxis Dr. Beate Schwarz
  • Memmingen, Germany, 87700
    • Beldio Research GmbH
  • Osnabruck, Germany, 49074
    • Klifos - Klinische Forschung Osnabruck
• Poland
  • Elblag, Poland, 82-300
    • Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
  • Warszawa, Poland, 02-793
    • ETG Warszawa
• Spain
  • Alicante, Spain, 03010
    • Hospital General Universitario de Alicante
  • Barcelona, Spain, 08041
    • Hospital de la Santa Creu i Sant Pau
  • Madrid, Spain, 28007
    • Hospital General Universitario Gregorio Marañón
  • Manises, Spain, 46940
    • Hospital de Manises
  • Pozuelo de Alarcon, Spain, 28223
    • Hospital Universitario Quironsalud Madrid
• United States
  • Arizona
    • Phoenix, Arizona, United States, 85018
      • Southwest Skin Specialists Phoenix Biltmore
  • California
    • Encino, California, United States, 91436
      • Raoof Md Encino
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
    • Huntington Beach, California, United States, 92647
      • Marvel Clinical Research Llc
  • Florida
    • Miami, Florida, United States, 33173
      • Well Pharma Medical Research Corporation
    • Pembroke Pines, Florida, United States, 33028
      • Psoriasis Treatment Center of South Florida
    • Sweetwater, Florida, United States, 33172
      • Lenus Research Medical Group, Llc
  • Georgia
    • Marietta, Georgia, United States, 30060
      • DelRicht Research
  • Illinois
    • Rolling Meadows, Illinois, United States, 60008
      • Arlington Dermatology
    • Springfield, Illinois, United States, 62604
      • Midwest Allergy Sinus Asthma, Sc
  • Kentucky
    • Louisville, Kentucky, United States, 40241
      • Dermatologist Specialist
  • Louisiana
    • Houma, Louisiana, United States, 70364
      • Grafton Dermatology and Cosmetic Surgery
    • New Orleans, Louisiana, United States, 70115
      • DelRicht Research
  • Missouri
    • Saint Louis, Missouri, United States, 63110
      • Washington University
  • Nevada
    • Las Vegas, Nevada, United States, 89106
      • Jubilee Clinical Research Inc
  • New York
    • New York, New York, United States, 10022
      • JUVA Skin and Laser Center
  • Oregon
    • Portland, Oregon, United States, 97239
      • Oregon Health & Science University
    • Portland, Oregon, United States, 97223
      • Oregon Medical Research Center
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center
    • Murfreesboro, Tennessee, United States, 37130
      • International Clinical Research Tennessee Llc
  • Texas
    • Houston, Texas, United States, 77056
      • Austin Institute For Clinical Research Aicr Pflugerville
    • San Antonio, Texas, United States, 78213
      • Progressive Clinical Research
    • Webster, Texas, United States, 77598
      • Center For Clinical Studies Webster
  • Utah
    • Murray, Utah, United States, 84107
      • University of Utah
  • Virginia
    • Richmond, Virginia, United States, 23233
      • West End Dermatology Associates
  • Washington
    • Spokane, Washington, United States, 99202
      • Dermatology Specialists of Spokane

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 97 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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.
• Further exclusion criteria apply.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ruxolitinib; 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; Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.; Other Names: INCB18424 cream
Placebo Comparator: Vehicle; Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.	Drug: Vehicle; Vehicle cream is a topical formulation applied as a thin film to affected areas.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score	The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.	Week 16
Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score	The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).	Week 16
Change from baseline in the modified Total Lesion Symptom Score (mTLSS)	The mTLSS is a validated tool for assessing hand eczema. The scale quantifies the 7 features (erythema, scaling, hyperkeratosis/lichenification, vesiculation, oedema, fissures, and pruritus/pain) of HE (0 = none, 1 = mild, 2 = moderate, and 3 = severe).	Up to Week 32
Proportion of participants achieving an IGA-CHE-TS from baseline	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.	Up to Week 32
Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average)	The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable).	Up to Week 32
Change from baseline in CHE-related Pain NRS score (weekly average)	The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).	Up to Week 32
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score	The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their itch on an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable) on a daily basis.	Up to Week 32
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score.	The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subject will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable) on a daily basis.	Up to Week 32
Percentage change in Hand Eczema Severity Index (HECSI)	The Hand Eczema Severity Index (HECSI) is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.	Week 16
Proportion of Participants with HECSI-75	HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.	Weeks 2, 8, 16 and 32
Proportion of participants with HECSI-90	HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs (erythema, infiltration/papulation, vesicles, fissures, scaling, and oedema) and the extent of the lesions in each of the 5 hand regions (fingertips, fingers [except fingertips], palm of hands, back of hands, and wrists) by use of standard scales.	Weeks 2, 8, 16, and 32
Mean Patient Global Impression of Change (PGIC) score	The Patient Global Impression of Change (PGIC)is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.	Up to Week 32
Proportion of participants with each score on the PGIC	The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.	Up to Week 32
Proportion of Participants with a score of either 1 or 2 on the PGIC	The PGIC is based on a 7-point scale and the participant will rate each question from the start of treatment as 1-very much improved, 2-much improved, 3-minimally improved, 4-no change, 5-minimally worse, 6-much worse, and 7-very much worse.	Up to Week 32

Collaborators and Investigators

• Sponsor: Incyte Corporation
• Investigators: Study Director: Haq Nawaz, md, Incyte Corporation

Study record dates

Study Major Dates

• Study Start (Anticipated): January 31, 2023
• Primary Completion (Anticipated): April 25, 2024
• Study Completion (Anticipated): September 22, 2024

Study Registration Dates

• First Submitted: January 21, 2022
• First Submitted That Met QC Criteria: January 21, 2022
• First Posted (Actual): February 2, 2022

Study Record Updates

• Last Update Posted (Actual): November 17, 2022
• Last Update Submitted That Met QC Criteria: November 14, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: eczema; JAK inhibitor; skin disease; dermatitis; chronic hand eczema (CHE)
• Additional Relevant MeSH Terms: Skin Diseases; Dermatitis; Skin Diseases, Eczematous; Eczema
• Other Study ID Numbers: INCB 18424-313

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No