Clinical trial NCT05233410: Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
Official title: Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2 (TRuE-CHE2): 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Chronic Hand Eczema (CHE)
Keywords: eczema
hand eczema
dermatitis
skin disease
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-10
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Maximum age (years): 99
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: 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.
Primary purpose: TREATMENT

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).


Eligibility criteria: 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.

Primary outcomes:
measure: Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
timeFrame: Week 16
Secondary outcomes:
measure: Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score
timeFrame: Baseline to Week 16
measure: Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score
timeFrame: Baseline to Week 16
measure: Change from baseline in the mTLSS (modified Total Lesion Symptom Score
timeFrame: Up to Week 32
measure: Percentage of Participants achieving an IGA CHE-TS
timeFrame: Up to Week 32
measure: Change from baseline in CHE-related Itch NRS score (weekly average)
timeFrame: Up to Week 32
measure: Change from baseline in CHE-related Skin Pain NRS score (weekly average)
timeFrame: Up to Week 32
measure: Time to ≥ 4-point improvement in CHE-related Itch NRS score
timeFrame: Up to Week 32
measure: Time to ≥ 2-point improvement in CHE-related Skin Pain NRS score
timeFrame: Up to Week 32
measure: Percentage change in Hand Eczema Severity Index (HECSI)
timeFrame: Baseline to Week 16
measure: Percentage of participants with HECSI-75
timeFrame: Weeks 2, 8, 16, 32
measure: Percentage of participants with HECSI-90
timeFrame: Weeks 2, 8, 16, 32
measure: Mean Patient Global Impression of Change (PGIC) score
timeFrame: Up to Week 32
measure: Percentage of participants with each score on the PGIC
timeFrame: Up to Week 32
measure: Percentage of participants with a score of either 1 or 2 on the PGIC
timeFrame: Up to Week 32
measure: Change from baseline in Dermatology Life Quality Index (DLQI) score
timeFrame: Up to Week 32
measure: Change from baseline in EQ-5D-5L score
timeFrame: Up to Week 32
measure: Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score
timeFrame: Up to Week 32
measure: Change from baseline in Working Limitations Questionnaire (WLQ) score
timeFrame: Up to Week 32
measure: Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)
timeFrame: Up to week 32, followed by 30 days follow-up.
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to 40 weeks
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama Hospital
state: Alabama
city: Huntington Beach
country: United States
facility: Marvel Clinical Research LLC
state: California
city: Westminster
country: United States
facility: Advanced RX Clin Research
state: California
city: Westminster
country: United States
facility: Advanced Rx Clinical Research
state: California
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Springfield
country: United States
facility: Midwest Allergy Sinus Asthma, Sc
state: Illinois
city: Plainfield
country: United States
facility: The Indiana Clinical Trials Center Ictc
state: Indiana
city: Baton Rouge
country: United States
facility: Delricht Research
state: Louisiana
city: Las Vegas
country: United States
facility: Jubilee
state: Nevada
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, Llc Charlotte Central Office
state: North Carolina
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Milwaukee
country: United States
facility: Froedtert & Medical College of Wisconsin
state: Wisconsin
city: Sevlievo
country: Bulgaria
facility: Medical Center Unimed Eood
city: Sofia
country: Bulgaria
facility: Dcc 'Alexandrovska', Eood
city: Sofia
country: Bulgaria
facility: Medical Center Hera Eood
city: Sofia
country: Bulgaria
facility: Dcc Xxviii
city: Sofia
country: Bulgaria
facility: Mc 'Synexus - Sofia', Eood
city: Sofia
country: Bulgaria
facility: Dcc 'Alexandrovska', Eood
city: Surrey
country: Canada
facility: Dr. Chih-Ho Hong Medical Inc.
state: British Columbia
city: Barrie
country: Canada
facility: Simcomed Health Ltd
state: Ontario
city: Windsor
country: Canada
facility: Xlr8 Medical Research
state: Ontario
city: Brno
country: Czechia
facility: Fakultni Nemocnice U Sv. Anny V Brne
city: Praha 10
country: Czechia
facility: Clintrial SRO
city: Usti Nad Labem
country: Czechia
facility: Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
city: Berlin
country: Germany
facility: Charite Universitaetsmedizin Berlin - Campus Charite Mitte
city: Frankfurt
country: Germany
facility: Universitaetsklinikum Frankfurt
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen Gmbh
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg Gemeinschaftspraxis Gbr
city: Luebeck
country: Germany
facility: Universitaetsklinikum Schleswig Holstein - Campus Luebeck
city: Mahlow
country: Germany
facility: Gemeinschaftspraxis
city: Memmingen
country: Germany
facility: Beldio Research Gmbh
city: Muenchen
country: Germany
facility: Dermatologische Klinik Der Technischen Universitat Munchen
city: Osnabruck
country: Germany
facility: Klifos - Klinische Forschung Osnabrück
city: Warsaw
country: Poland
facility: Etg Warszawa
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Madrid
country: Spain
facility: Clinica Dermomedic
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Marañon
city: Madrid
country: Spain
facility: Hospital Universitario Quironsalud Madrid
city: Valencia
country: Spain
facility: Hospital de Manises
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: