Topical Ruxolitinib Evaluation in Chronic Hand Eczema
- Registration Number
- NCT05906628
- Lead Sponsor
- Incyte Corporation
- 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).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 186
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vehicle Vehicle Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period. Ruxolitinib Ruxolitinib cream 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.
- Primary Outcome Measures
Name Time Method Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Week 16 Baseline; Week 16 The Investigator's Global Assessment-Chronic Hand Eczema (IGA-CHE) is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). 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
Name Time Method Percentage of Participants Achieving ITCH4 Response at Day 3 and Week 1 (Day 7) Baseline; Day 3; Week 1 (Day 7) ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch).
Percentage of Participants With Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) at Each Post-Baseline Visit Baseline; Weeks 2, 4, 8, 12, 16, 24, and 32 The IGA-CHE is an instrument used to rate the severity of the participant's global CHE and is based on a 5-point scale ranging from 0 (clear) to 4 (severe) (1, almost clear; 2, mild eczema; 3, moderate eczema). 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 at Each Post-Baseline Visit Baseline; Weeks 1-32 The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Time to ≥4-point Improvement From Baseline in CHE-related Itch NRS Score Baseline; up to Week 32 ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch).
Change From Baseline in CHE-related Pain NRS Score at Each Post-Baseline Visit Baseline; Weeks 1-32 The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Percentage of Participants Achieving ≥2-point Improvement in CHE-related Skin Pain NRS Score From Baseline to Week 16 Baseline; up to Week 16 The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain).
Time to ≥2-point Improvement From Baseline in CHE-related Skin Pain NRS Score Baseline; up to Week 32 The CHE-related Pain NRS is a once-per-24 hours ("daily") participant-reported measure of the worst pain severity of their CHE assessed using an 11-point scale (0=no pain to 10=worst imaginable pain).
Percentage Change in Hand Eczema Severity Index (HECSI) Score From Baseline to Week 16 Baseline; up to Week 16 The HECSI divides the hand into 5 areas for assessment (fingertips, fingers \[except the tips\], palms, back of hands, and wrists). Each of the 5 areas of the hand are assessed separately for erythema, induration/papulation, vesicles, fissuring, scaling, and edema using the following scale: 0, no skin changes; 1, mild disease; 2, moderate disease; and 3, severe disease. To determine the HECSI score, the affected area for each location (total of both hands) is given a score from 0 to 4 (0, 0%; 1, 1%-25%; 2, 26%-50%; 3, 51%-75%; and 4, 76%-100%) based on the extent of clinical symptoms. Finally, the score given for the extent at each location is multiplied by the total sum of the intensity of each clinical feature to calculate the total HECSI score, varying from 0 to a maximum severity score of 360 points. Percentage change was calculated as the (\[post-Baseline value minus the Baseline value\]/\[Baseline value\]) \* 100.
Patient Global Impression of Change (PGIC) Score at Each Post-Baseline Visit Baseline; up to Week 32 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. Participants were asked to select 1 response from the response options that best described the overall change in their CHE since they started study treatment: 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 at Weeks 2, 4, 8, 12, 16, 24, and 32 Baseline; up to Week 32 The DLQI is a simple, 10-question validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. The questionnaire was analyzed under 6 subscales as follows: symptoms and feelings (Questions 1 and 2); daily activities (Questions 3 and 4); leisure (Questions 5 and 6); work and school (Question 7); personal relations (Questions 8 and 9); and treatment (Question 10). Scoring of each question is as follows: very much = 3; a lot = 2; a little = 1; not at all = 0; not relevant = 0 (Question 7: "Prevented work or studying" = Yes = 3). The DLQI was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life was impaired.
Number of Participants With the Indicated EQ-5D-5L Dimension Scores at Weeks 2, 4, 8, 12, 16, 24, and 32 Baseline; up to Week 32 The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems; Level 2 = slight problems; Level 3 = moderate problems; Level 4 = severe problems; and Level 5 = extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score).
Percentage of Participants Achieving ITCH4 Response at Weeks 4 and 16 Baseline; Weeks 4 and 16 ITCH4 response was defined as a ≥4-point improvement in CHE-related Itch Numerical Rating Scale (NRS) score from Baseline. The CHE-related Itch NRS is a once-per-24 hours ("daily") participant-reported measure of the worst itch severity of their CHE assessed using an 11-point scale (0=no itch to 10=worst imaginable itch).
Change From Baseline in EQ-5D-5L Visual Analog Scale (VAS) Score at Weeks 2, 4, 8, 12, 16, 24, and 32 Baseline; up to Week 32 The EQ-5D-5L questionnaire is a standardized, validated instrument for use as a measure of health outcome. The EQ-5D-5L questionnaire consists of the following 2 sections: the EQ-5D descriptive system and the EQ Visual Analog Scale (VAS). The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: Level 1 = no problems; Level 2 = slight problems; Level 3 = moderate problems; Level 4 = severe problems; and Level 5 = extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), where the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in Quality of Life in Hand Eczema Questionnaire (QOLHEQ) Total Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Baseline; up to Week 36 The QOLHEQ is a validated disease-specific instrument to assess disease-specific health-related quality of life in participants suffering from CHE over the past 7 days. It consists of 30 items that are summarized according to impairments for 4 subscales: symptoms, emotions, limitations in functioning, and treatment and prevention. Each item is scored on a scale of never, rarely, sometimes, often, and all the time. The overall score is calculated by summing all items and ranges from 0 to 117. Higher scores indicate a greater impact on quality of life. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Change From Baseline in Work Productivity and Activity Impairment Questionnaire v2.0 in Chronic Hand Dermatitis (WPAI-ChHD) Score at Weeks 2, 4, 8, 12, 16, 24, 32, and Follow-up Baseline; up to Week 36 The WPAI-ChHD questionnaire is a patient-reported quantitative assessment of the amount of absenteeism (measured as percentage of work time missed \[PWTM\] due to CHE), presentism, and daily activity impairment (percentage of impairment while working \[PIWW\] due to CHE, percentage of overall work impairment \[POWI\] due to CHE, percentage of activity impairment \[PAI\] due to CHE) attributable to a specific health problem. The WPAI-ChHD is a 6-item questionnaire used to assess the impact of chronic hand dermatitis (ChHD, the same as CHE in this context) on job performance and productivity in the last 7 days. WPAI outcomes are expressed as impairment percentages, with higher numbers indicating greater impairment and less productivity. Scores range from 0% (no impairment) to 100% (complete impairment). Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) in the DBVC Period up to Week 16 An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Number of Participants With Any ≥Grade 3 TEAE in the DBVC Period up to Week 16 A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Any TEAE in the OLE Period up to Week 36 An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not it was considered drug related. An AE could therefore have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up.
Number of Participants With Any ≥Grade 3 TEAE in the OLE Period up to Week 36 A TEAE was defined as any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug until the end of the safety follow-up. The severity of AEs was based on the National Cancer Institute Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 using Grades 1 through 5. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the DBVC Period up to Week 16 The investigator determined whether a change was clinically meaningful.
Number of Participants With Clinically Meaningful Changes or Trends in Laboratory (Hematology and Serum Chemistry) Parameters or Vital Signs in the OLE Period up to Week 36 The investigator determined whether a change was clinically meaningful.
Trial Locations
- Locations (35)
Southwest Skin Specialists Phoenix Biltmore
🇺🇸Phoenix, Arizona, United States
First Oc Dermatology
🇺🇸Fountain Valley, California, United States
Marvel Clinical Research Llc
🇺🇸Huntington Beach, California, United States
Dermatology Research Associates
🇺🇸Los Angeles, California, United States
Skin Research of South Florida, Llc
🇺🇸Miami, Florida, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
Forcare Clinical Research
🇺🇸Tampa, Florida, United States
Midwest Allergy Sinus Asthma, Sc
🇺🇸Normal, Illinois, United States
The Indiana Clinical Trials Center Ictc
🇺🇸Plainfield, Indiana, United States
Delricht Research
🇺🇸New Orleans, Louisiana, United States
Scroll for more (25 remaining)Southwest Skin Specialists Phoenix Biltmore🇺🇸Phoenix, Arizona, United States