Back to resultsTopical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2 (TRuE-CHE2)
Primary Purpose
Chronic Hand Eczema (CHE)
Status
Withdrawn
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Ruxolitinib cream
Vehicle
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Hand Eczema (CHE) focused on measuring eczema, hand eczema, dermatitis, skin disease, JAK inhibitor
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.
Sites / Locations
- University of Alabama Hospital
- Marvel Clinical Research LLC
- Advanced RX Clin Research
- Advanced Rx Clinical Research
- Forcare Clinical Research
- Midwest Allergy Sinus Asthma, Sc
- The Indiana Clinical Trials Center Ictc
- Delricht Research
- Jubilee
- Onsite Clinical Solutions, Llc Charlotte Central Office
- Progressive Clinical Research
- Froedtert & Medical College of Wisconsin
- Medical Center Unimed Eood
- Dcc 'Alexandrovska', Eood
- Medical Center Hera Eood
- Dcc Xxviii
- Mc 'Synexus - Sofia', Eood
- Dcc 'Alexandrovska', Eood
- Dr. Chih-Ho Hong Medical Inc.
- Simcomed Health Ltd
- Xlr8 Medical Research
- Fakultni Nemocnice U Sv. Anny V Brne
- Clintrial SRO
- Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
- Charite Universitaetsmedizin Berlin - Campus Charite Mitte
- Universitaetsklinikum Frankfurt
- Derma-Study-Center Friedrichshafen Gmbh
- Dermatologikum Hamburg Gemeinschaftspraxis Gbr
- Universitaetsklinikum Schleswig Holstein - Campus Luebeck
- Gemeinschaftspraxis
- Beldio Research Gmbh
- Dermatologische Klinik Der Technischen Universitat Munchen
- Klifos - Klinische Forschung Osnabrück
- Etg Warszawa
- Hospital General Universitario de Alicante
- Clinica Dermomedic
- Hospital General Universitario Gregorio Marañon
- Hospital Universitario Quironsalud Madrid
- Hospital de Manises
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Ruxolitinib
Vehicle
Arm Description
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.
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Outcomes
Primary Outcome Measures
Percentage 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.
Secondary Outcome Measures
Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects 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.
Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Change from baseline in the mTLSS (modified Total Lesion Symptom Score
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).
Percentage of Participants achieving an 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.
Change from baseline in CHE-related Itch NRS score (weekly average)
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.
Change from baseline in CHE-related Skin Pain NRS score (weekly average)
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time to ≥ 4-point improvement in CHE-related Itch NRS score
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and participants 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.
Time to ≥ 2-point improvement in CHE-related Skin Pain NRS score
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants 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.
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.
Percentage 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.
Percentage 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.
Mean Patient Global Impression of Change (PGIC) score
The Patient Global Impression of Change (PGIC) is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Percentage of participants with each score on the PGIC
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Percentage of participants with a score of either 1 or 2 on the PGIC
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Change from baseline in Dermatology Life Quality Index (DLQI) score
The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Change from baseline in EQ-5D-5L score
EQ-5D-5L is a is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score
The QOLHEQ is a validated instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.
Change from baseline in Working Limitations Questionnaire (WLQ) score
The Work Limitations Questionnaire (WLQ) is a patient self-rated scale designed to assess on the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5- point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24.9%. Higher percent productivity loss reflects more severe work limitations.
Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)
The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05233410
Brief Title
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
Acronym
TRuE-CHE2
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
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Withdrawn
Why Stopped
Business decision; no safety concerns
Study Start Date
January 31, 2023 (Anticipated)
Primary Completion Date
April 25, 2024 (Anticipated)
Study Completion Date
September 22, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Incyte Corporation
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Hand Eczema (CHE)
Keywords
eczema, hand eczema, dermatitis, skin disease, JAK inhibitor
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare ProviderOutcomes Assessor
Allocation
Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Ruxolitinib
Arm Type
Experimental
Arm Description
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.
Arm Title
Vehicle
Arm Type
Placebo Comparator
Arm Description
Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
Intervention Type
Drug
Intervention Name(s)
Ruxolitinib cream
Other Intervention Name(s)
INCB18424 cream
Intervention Description
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
Intervention Type
Drug
Intervention Name(s)
Vehicle
Intervention Description
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Primary Outcome Measure Information:
Title
Percentage of Participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS)
Description
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.
Time Frame
Week 16
Secondary Outcome Measure Information:
Title
Percentage of Participants with a ≥ 4-point improvement in chronic hand eczema (CHE)-related Itch Numerical Rating Scale (NRS) score
Description
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects 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.
Time Frame
Baseline to Week 16
Title
Percentage of Participants with a ≥ 2-point improvement in CHE-related Skin Pain NRS score
Description
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and subjects will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Baseline to Week 16
Title
Change from baseline in the mTLSS (modified Total Lesion Symptom Score
Description
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).
Time Frame
Up to Week 32
Title
Percentage of Participants achieving an IGA CHE-TS
Description
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.
Time Frame
Up to Week 32
Title
Change from baseline in CHE-related Itch NRS score (weekly average)
Description
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.
Time Frame
Up to Week 32
Title
Change from baseline in CHE-related Skin Pain NRS score (weekly average)
Description
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants will rate the intensity of their pain on an 11-point scale ranging from 0 (no pain) to 10 (worst pain imaginable).
Time Frame
Up to Week 32
Title
Time to ≥ 4-point improvement in CHE-related Itch NRS score
Description
The Itch NRS is a validated, self-reported, instrument for measurement of itch intensity and participants 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.
Time Frame
Up to Week 32
Title
Time to ≥ 2-point improvement in CHE-related Skin Pain NRS score
Description
The Pain NRS is a validated, self-reported, instrument for measurement of itch intensity and participants 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.
Time Frame
Up to Week 32
Title
Percentage change in Hand Eczema Severity Index (HECSI)
Description
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.
Time Frame
Baseline to Week 16
Title
Percentage of participants with HECSI-75
Description
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.
Time Frame
Weeks 2, 8, 16, 32
Title
Percentage of participants with HECSI-90
Description
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.
Time Frame
Weeks 2, 8, 16, 32
Title
Mean Patient Global Impression of Change (PGIC) score
Description
The Patient Global Impression of Change (PGIC) is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Time Frame
Up to Week 32
Title
Percentage of participants with each score on the PGIC
Description
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Time Frame
Up to Week 32
Title
Percentage of participants with a score of either 1 or 2 on the PGIC
Description
The PGIC is a participants' self-reporting measure that reflects their belief about the efficacy of treatment. The PGIC is a 7-point scale depicting a participant's rating of overall improvement of CHE and will be captured during site visits. It 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.
Time Frame
Up to Week 32
Title
Change from baseline in Dermatology Life Quality Index (DLQI) score
Description
The DLQI is a simple, 10 question (Q) validated quality-of-life questionnaire to measure how much the skin problem has affected the participant. It covers 6 domains including symptoms and feelings (Q1 and Q2), daily activities (Q3 and Q4), leisure (Q5 and Q6), work and school (Q7), personal relationships (Q8 and Q9), and treatment(Q10). The recall Period of this scale is over the last week. Response categories include 0-not at all, 1-a little, 2-a lot, and 3-very much, and unanswered or not relevant responses scored as 0. Scores range from 0 ("no impact on participant's life") to 30 ("extremely large effect on participant's life"), and a 4-point change from Baseline is considered as the minimal clinically important difference threshold. A negative change from Baseline indicates less impact of the skin problem on participant's life.
Time Frame
Up to Week 32
Title
Change from baseline in EQ-5D-5L score
Description
EQ-5D-5L is a is a validated, self-administered, generic, utility questionnaire wherein participants will rate their current health state based on the following criteria: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression.
Time Frame
Up to Week 32
Title
Change from baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) score
Description
The QOLHEQ is a validated instrument to assess disease specific Health Related Quality of Life (HRQOL) in patients suffering from hand eczema. The QOLHEQ is a disease specific instrument, thereby only assessing impairments caused by hand eczema. It consists out of 30 items which can be summarized according to four domains of HRQOL: Impairments because of (1) symptoms, (2) emotions, (3) limitations in functioning or (4) because of treatment and prevention.
Time Frame
Up to Week 32
Title
Change from baseline in Working Limitations Questionnaire (WLQ) score
Description
The Work Limitations Questionnaire (WLQ) is a patient self-rated scale designed to assess on the-job impact of chronic health problems and/or treatment. The WLQ consists of 25 items in 4 dimensions: limitations handling time (5 items), physical work demands (6 items), mental interpersonal work demands (9 items), and output demands (5 items). Each item is rated on a 5- point scale from "All of the Time" (score 5) to "None of the Time" (score 0), or "Does Not Apply to My Job". The WLQ Productivity Loss Score is derived from the Global Productivity Index, which is calculated as a weighed sum of the 4 dimensions. Reduction in WLQ Productivity Loss score indicates less work limitation and represents the estimated percentage of productivity loss in the past two weeks due to presenteeism relative to a healthy benchmark sample. WLQ Productivity Loss Score ranges from 0% to 24.9%. Higher percent productivity loss reflects more severe work limitations.
Time Frame
Up to Week 32
Title
Change from baseline in Work Productivity and Activity Impairment Questionnaire Specific Health Problem v2.0 in Chronic Hand Eczema (WPAI-SHP-CHE)
Description
The WPAI:SHP questionnaire assesses both work productivity through absenteeism (i.e., work time missed), presenteeism (i.e., impairment at work or reduced on-the-job effectiveness), and work productivity loss, as well as daily activity impairment (e.g., work around the house, shopping, exercising, childcare, studying) attributable to excess weight. Results of WPAI are expressed as a percentage of impairment from 0 to 100, with higher percentages indicating greater impairment and less productivity. Negative numbers indicate improvement from baseline.
Time Frame
Up to week 32, followed by 30 days follow-up.
Title
Number of Participants with Treatment Emergent Adverse Events (TEAE)
Description
Defined as any adverse event either reported for the first time or worsening of a pre-existing event after first dose of study drug.
Time Frame
Up to 40 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Haq Nawaz, MD
Organizational Affiliation
Incyte Corporation
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama Hospital
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35249
Country
United States
Facility Name
Marvel Clinical Research LLC
City
Huntington Beach
State/Province
California
ZIP/Postal Code
92647
Country
United States
Facility Name
Advanced RX Clin Research
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Advanced Rx Clinical Research
City
Westminster
State/Province
California
ZIP/Postal Code
92683
Country
United States
Facility Name
Forcare Clinical Research
City
Tampa
State/Province
Florida
ZIP/Postal Code
33613
Country
United States
Facility Name
Midwest Allergy Sinus Asthma, Sc
City
Springfield
State/Province
Illinois
ZIP/Postal Code
62704
Country
United States
Facility Name
The Indiana Clinical Trials Center Ictc
City
Plainfield
State/Province
Indiana
ZIP/Postal Code
46168
Country
United States
Facility Name
Delricht Research
City
Baton Rouge
State/Province
Louisiana
ZIP/Postal Code
70809
Country
United States
Facility Name
Jubilee
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89106
Country
United States
Facility Name
Onsite Clinical Solutions, Llc Charlotte Central Office
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28277
Country
United States
Facility Name
Progressive Clinical Research
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78213
Country
United States
Facility Name
Froedtert & Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Medical Center Unimed Eood
City
Sevlievo
ZIP/Postal Code
05402
Country
Bulgaria
Facility Name
Dcc 'Alexandrovska', Eood
City
Sofia
ZIP/Postal Code
01431
Country
Bulgaria
Facility Name
Medical Center Hera Eood
City
Sofia
ZIP/Postal Code
01510
Country
Bulgaria
Facility Name
Dcc Xxviii
City
Sofia
ZIP/Postal Code
01592
Country
Bulgaria
Facility Name
Mc 'Synexus - Sofia', Eood
City
Sofia
ZIP/Postal Code
01784
Country
Bulgaria
Facility Name
Dcc 'Alexandrovska', Eood
City
Sofia
ZIP/Postal Code
1431
Country
Bulgaria
Facility Name
Dr. Chih-Ho Hong Medical Inc.
City
Surrey
State/Province
British Columbia
ZIP/Postal Code
V3R 6A7
Country
Canada
Facility Name
Simcomed Health Ltd
City
Barrie
State/Province
Ontario
ZIP/Postal Code
L4M 1G7
Country
Canada
Facility Name
Xlr8 Medical Research
City
Windsor
State/Province
Ontario
ZIP/Postal Code
N8W 1E6
Country
Canada
Facility Name
Fakultni Nemocnice U Sv. Anny V Brne
City
Brno
ZIP/Postal Code
656 91
Country
Czechia
Facility Name
Clintrial SRO
City
Praha 10
ZIP/Postal Code
100 00
Country
Czechia
Facility Name
Krajska Zdravotni A.S. - Masarykova Nemocnice V Usti Nad Labem O.Z.
City
Usti Nad Labem
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Charite Universitaetsmedizin Berlin - Campus Charite Mitte
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Facility Name
Derma-Study-Center Friedrichshafen Gmbh
City
Friedrichshafen
ZIP/Postal Code
88045
Country
Germany
Facility Name
Dermatologikum Hamburg Gemeinschaftspraxis Gbr
City
Hamburg
ZIP/Postal Code
20354
Country
Germany
Facility Name
Universitaetsklinikum Schleswig Holstein - Campus Luebeck
City
Luebeck
ZIP/Postal Code
23538
Country
Germany
Facility Name
Gemeinschaftspraxis
City
Mahlow
ZIP/Postal Code
15381
Country
Germany
Facility Name
Beldio Research Gmbh
City
Memmingen
ZIP/Postal Code
87700
Country
Germany
Facility Name
Dermatologische Klinik Der Technischen Universitat Munchen
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Klifos - Klinische Forschung Osnabrück
City
Osnabruck
ZIP/Postal Code
49074
Country
Germany
Facility Name
Etg Warszawa
City
Warsaw
ZIP/Postal Code
02-777
Country
Poland
Facility Name
Hospital General Universitario de Alicante
City
Alicante
ZIP/Postal Code
03010
Country
Spain
Facility Name
Clinica Dermomedic
City
Madrid
ZIP/Postal Code
28001
Country
Spain
Facility Name
Hospital General Universitario Gregorio Marañon
City
Madrid
ZIP/Postal Code
28007
Country
Spain
Facility Name
Hospital Universitario Quironsalud Madrid
City
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital de Manises
City
Valencia
ZIP/Postal Code
46940
Country
Spain
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 2
We'll reach out to this number within 24 hrs