Clinical trial NCT05219864: Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
Official title: 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
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Hand Eczema
Keywords: eczema
chronic hand eczema (CHE)
dermatitis
skin disease
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2022-02-02
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: Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
timeFrame: Week 16
measure: Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score
timeFrame: Week 16
measure: Change from baseline in the modified Total Lesion Symptom Score (mTLSS)
timeFrame: Up to Week 32
measure: Proportion of participants achieving an IGA-CHE-TS from baseline
timeFrame: Up to Week 32
measure: Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average)
timeFrame: Up to Week 32
measure: Change from baseline in CHE-related Pain NRS score (weekly average)
timeFrame: Up to Week 32
measure: Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score
timeFrame: Up to Week 32
measure: Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score.
timeFrame: Up to Week 32
measure: Percentage change in Hand Eczema Severity Index (HECSI)
timeFrame: Week 16
measure: Proportion of Participants with HECSI-75
timeFrame: Weeks 2, 8, 16 and 32
measure: Proportion of participants with HECSI-90
timeFrame: Weeks 2, 8, 16, and 32
measure: Mean Patient Global Impression of Change (PGIC) score
timeFrame: Up to Week 32
measure: Proportion of participants with each score on the PGIC
timeFrame: Up to Week 32
measure: Proportion of Participants with a score of either 1 or 2 on the PGIC
timeFrame: Up to Week 32
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Skin Specialists Phoenix Biltmore
state: Arizona
city: Encino
country: United States
facility: Raoof Md Encino
state: California
city: Fountain Valley
country: United States
facility: First Oc Dermatology
state: California
city: Huntington Beach
country: United States
facility: Marvel Clinical Research Llc
state: California
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Pembroke Pines
country: United States
facility: Psoriasis Treatment Center of South Florida
state: Florida
city: Sweetwater
country: United States
facility: Lenus Research Medical Group, Llc
state: Florida
city: Marietta
country: United States
facility: Delricht Research
state: Georgia
city: Rolling Meadows
country: United States
facility: Arlington Dermatology
state: Illinois
city: Springfield
country: United States
facility: Midwest Allergy Sinus Asthma, Sc
state: Illinois
city: Louisville
country: United States
facility: Dermatologist Specialist
state: Kentucky
city: Houma
country: United States
facility: Grafton Dermatology and Cosmetic Surgery
state: Louisiana
city: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Saint Louis
country: United States
facility: Washington University
state: Missouri
city: Las Vegas
country: United States
facility: Jubilee Clinical Research Inc
state: Nevada
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Health & Science University
state: Oregon
city: Memphis
country: United States
facility: Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center
state: Tennessee
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Houston
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: San Antonio
country: United States
facility: Progressive Clinical Research
state: Texas
city: Webster
country: United States
facility: Center For Clinical Studies Webster
state: Texas
city: Murray
country: United States
facility: University of Utah
state: Utah
city: Richmond
country: United States
facility: West End Dermatology Associates
state: Virginia
city: Spokane
country: United States
facility: Dermatology Specialists of Spokane
state: Washington
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Red Deer
country: Canada
facility: Care Clinic
state: Alberta
city: Ajax
country: Canada
facility: Cca Medical Research
state: Ontario
city: Markham
country: Canada
facility: Lynderm Research Inc
state: Ontario
city: Brno
country: Czechia
facility: Fakultni Nemocnice U Sv. Anny V Brne
city: Ostrava
country: Czechia
facility: Ccr Ostrava S.R.O.
city: Pardubice
country: Czechia
facility: Ccr Czech A.S.
city: Praha 10
country: Czechia
facility: Clintrial S.R.O.
city: Usti Nad Labem
country: Czechia
facility: Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
city: Frankfurt
country: Germany
facility: Klinikum Der Johann Wolfgang Goethe-Universitaet
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Friedrichshafen Gmbh
city: Hamburg
country: Germany
facility: Dermatologikum Hamburg Gemeinschaftspraxis Gbr
city: Kiel
country: Germany
facility: Universitaetsklinikum Schleswig-Holstein
city: Langenau
country: Germany
facility: Praxis Dr. Beate Schwarz
city: Memmingen
country: Germany
facility: Beldio Research Gmbh
city: Osnabruck
country: Germany
facility: Klifos - Klinische Forschung Osnabruck
city: Elblag
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
city: Warszawa
country: Poland
facility: Etg Warszawa
city: Alicante
country: Spain
facility: Hospital General Universitario de Alicante
city: Barcelona
country: Spain
facility: Hospital de La Santa Creu I Sant Pau
city: Madrid
country: Spain
facility: Hospital General Universitario Gregorio Maranon
city: Manises
country: Spain
facility: Hospital de Manises
city: Pozuelo de Alarcon
country: Spain
facility: Hospital Universitario Quironsalud Madrid
Study officials:
affiliation: Incyte Corporation
name: Haq Nawaz, MD
role: STUDY_DIRECTOR
References: