Clinical trial NCT05906628: Topical Ruxolitinib Evaluation in Chronic Hand Eczema
Official title: A Phase 2, 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: COMPLETED
Phase: PHASE2
Conditions: Hand Eczema
Keywords: eczema
chronic hand eczema (CHE)
dermatitis
skin disease
JAK inhibitor
Lead sponsor: Incyte Corporation
Sponsor class: INDUSTRY
First posted: 2023-06-18
Enrollment: 186
Sex: ALL
Minimum age (years): 18
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 CHE for at least 6 months prior to screening. 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.
* Have been treated with at least 1 prescription CHE therapy or if such therapy was not advisable or contraindicated.
* Willingness to avoid pregnancy or fathering children based on the criteria defined in the protocol.

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.
* Any serious illness or medical, physical, or psychiatric condition(s).
* 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.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

Primary outcomes:
measure: Proportion of participants achieving IGA-CHE-TS
timeFrame: Week 16
Secondary outcomes:
measure: Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch Numerical Rating Scale (NRS) score
timeFrame: Week 16
measure: Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
timeFrame: Week 4
measure: Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
timeFrame: Week 1 (Day 7)
measure: Proportion of participants achieving an IGA-CHE-TS from baseline
timeFrame: Up to Week 32
measure: Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score
timeFrame: Day 3
measure: Change from baseline in CHE-related Itch NRS score
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: Change from baseline in CHE-related Skin Pain NRS score
timeFrame: Up to Week 32
measure: Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score
timeFrame: Week 16
measure: Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score
timeFrame: Up to Week 32
measure: Percentage change from baseline in Hand Eczema Severity Index (HECSI)
timeFrame: Week 16
measure: Proportion of participants with each score on the PGIC
timeFrame: Up to Week 32
measure: Change from baseline in 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 QOLHEQ score
timeFrame: Up to week 32, followed by 30 days follow-up
measure: Change from baseline in WPAI-ChHD
timeFrame: Up to week 32, followed by 30 days follow-up
measure: Number of Participants with Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to week 32, followed by 30 days follow-up
Other outcomes:
Locations:
city: Phoenix
country: United States
facility: Southwest Skin Specialists Phoenix Biltmore
state: Arizona
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: Los Angeles
country: United States
facility: Dermatology Research Associates
state: California
city: Miami
country: United States
facility: Skin Research of South Florida, Llc
state: Florida
city: Miami
country: United States
facility: Well Pharma Medical Research Corporation
state: Florida
city: Tampa
country: United States
facility: Forcare Clinical Research
state: Florida
city: Normal
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: New Orleans
country: United States
facility: Delricht Research
state: Louisiana
city: Detroit
country: United States
facility: Henry Ford Medical Center
state: Michigan
city: Las Vegas
country: United States
facility: Jubilee Clinical Research Inc
state: Nevada
city: Kew Gardens
country: United States
facility: Forest Hills Dermatology Group
state: New York
city: New York
country: United States
facility: Juva Skin and Laser Center
state: New York
city: Charlotte
country: United States
facility: Onsite Clinical Solutions, Llc Charlotte Central Office
state: North Carolina
city: Bexley
country: United States
facility: Bexley Dermatology
state: Ohio
city: Oklahoma City
country: United States
facility: Central Sooner Research
state: Oklahoma
city: Portland
country: United States
facility: Oregon Dermatology and Research Center
state: Oregon
city: Portland
country: United States
facility: Oregon Medical Research Center
state: Oregon
city: Murfreesboro
country: United States
facility: International Clinical Research Tennessee Llc
state: Tennessee
city: Pflugerville
country: United States
facility: Austin Institute For Clinical Research Aicr Pflugerville
state: Texas
city: San Antonio
country: United States
facility: Dermatology Clinical Research Center of San Antonio
state: Texas
city: Calgary
country: Canada
facility: Dermatology Research Institute Inc.
state: Alberta
city: Red Deer
country: Canada
facility: Care Clinic
state: Alberta
city: Barrie
country: Canada
facility: Simcomed Health Ltd
state: Ontario
city: Bad Bentheim
country: Germany
facility: Fachklinik Bad Bentheim Dermatologie
city: Friedrichshafen
country: Germany
facility: Derma-Study-Center Fn Gmbh
city: Mahlow
country: Germany
facility: Dermatologische Gemeinschaftspraxis Mahlow
city: Memmingen
country: Germany
facility: Beldio Research Gmbh
city: Elblag
country: Poland
facility: Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.
city: Gdansk
country: Poland
facility: Centrum Badan Klinicznych Pi-House Sp. Z O.O.
city: Szczecin
country: Poland
facility: Laser Clinic S.C.
city: Szczecin
country: Poland
facility: Twoja Przychodnia - Szczecinskie Centrum Medyczne
city: Warszawa
country: Poland
facility: Klinika Ambroziak
city: Wroclaw
country: Poland
facility: Dermmedica Sp. Z O.O.
Study officials:
affiliation: Incyte Corporation
name: Incyte Medical Monitor
role: STUDY_DIRECTOR
References: