Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1

Hand Eczema Clinical Trial

— TRuE-CHE1  

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT05219864
• Other study ID #: INCB 18424-313
• Status: Withdrawn
• Phase: Phase 3
• Start date: January 31, 2023
• Est. completion date: September 22, 2024

Study information

• Verified date: November 2022
• Source: Incyte Corporation
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: September 22, 2024
• Est. primary completion date: April 25, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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.

Related Conditions & MeSH terms

• Eczema
• Hand Eczema

Intervention

Drug:
• Ruxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
• Vehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.

Locations

Country	Name	City	State
Canada	Cca Medical Research	Ajax	Ontario
Canada	Dermatology Research Institute Inc.	Calgary	Alberta
Canada	Lynderm Research Inc	Markham	Ontario
Canada	Care Clinic	Red Deer	Alberta
Czechia	Fakultni Nemocnice U Sv. Anny V Brne	Brno
Czechia	Ccr Ostrava S.R.O.	Ostrava
Czechia	Ccr Czech A.S.	Pardubice
Czechia	Clintrial S.R.O.	Praha 10
Czechia	Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.	Usti Nad Labem
Germany	Klinikum Der Johann Wolfgang Goethe-Universitaet	Frankfurt
Germany	Derma-Study-Center Friedrichshafen Gmbh	Friedrichshafen
Germany	Dermatologikum Hamburg Gemeinschaftspraxis Gbr	Hamburg
Germany	Universitaetsklinikum Schleswig-Holstein	Kiel
Germany	Praxis Dr. Beate Schwarz	Langenau
Germany	Beldio Research Gmbh	Memmingen
Germany	Klifos - Klinische Forschung Osnabruck	Osnabruck
Poland	Centrum Badawcze Panaceum Agnieszka Brzezicka, Magdalena Lenkiewicz Sp. Z O.O.	Elblag
Poland	Etg Warszawa	Warszawa
Spain	Hospital General Universitario de Alicante	Alicante
Spain	Hospital de La Santa Creu I Sant Pau	Barcelona
Spain	Hospital General Universitario Gregorio Maranon	Madrid
Spain	Hospital de Manises	Manises
Spain	Hospital Universitario Quironsalud Madrid	Pozuelo de Alarcon
United States	Raoof Md Encino	Encino	California
United States	First Oc Dermatology	Fountain Valley	California
United States	Grafton Dermatology and Cosmetic Surgery	Houma	Louisiana
United States	Austin Institute For Clinical Research Aicr Pflugerville	Houston	Texas
United States	Marvel Clinical Research Llc	Huntington Beach	California
United States	Jubilee Clinical Research Inc	Las Vegas	Nevada
United States	Dermatologist Specialist	Louisville	Kentucky
United States	Delricht Research	Marietta	Georgia
United States	Clinical Neuroscience Solutions Cns Healthcare Memphis Research Center	Memphis	Tennessee
United States	Well Pharma Medical Research Corporation	Miami	Florida
United States	International Clinical Research Tennessee Llc	Murfreesboro	Tennessee
United States	University of Utah	Murray	Utah
United States	Delricht Research	New Orleans	Louisiana
United States	Juva Skin and Laser Center	New York	New York
United States	Psoriasis Treatment Center of South Florida	Pembroke Pines	Florida
United States	Southwest Skin Specialists Phoenix Biltmore	Phoenix	Arizona
United States	Oregon Health & Science University	Portland	Oregon
United States	Oregon Medical Research Center	Portland	Oregon
United States	West End Dermatology Associates	Richmond	Virginia
United States	Arlington Dermatology	Rolling Meadows	Illinois
United States	Washington University	Saint Louis	Missouri
United States	Progressive Clinical Research	San Antonio	Texas
United States	Dermatology Specialists of Spokane	Spokane	Washington
United States	Midwest Allergy Sinus Asthma, Sc	Springfield	Illinois
United States	Lenus Research Medical Group, Llc	Sweetwater	Florida
United States	Center For Clinical Studies Webster	Webster	Texas

Sponsors (1)

Lead Sponsor	Collaborator
Incyte Corporation

Countries where clinical trial is conducted

United States,  Canada,  Czechia,  Germany,  Poland,  Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	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