Topical Ruxolitinib Evaluation in Chronic Hand Eczema Study 1
- Registration Number
- NCT05219864
- 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
- WITHDRAWN
- Sex
- All
- Target Recruitment
- Not specified
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description 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. Vehicle Vehicle Vehicle cream for 16 weeks followed by crossover to ruxolitinib cream 1.5% BID in a 16-week treatment extension period.
- Primary Outcome Measures
Name Time Method Proportion of participants achieving Investigator's Global Assessment-Chronic Hand Eczema Treatment Success (IGA-CHE-TS) Week 16 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
Name Time Method Proportion of participants with a ≥ 2-point improvement in CHE-related Pain NRS score Week 16 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).
Change from baseline in the modified Total Lesion Symptom Score (mTLSS) Up to Week 32 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).
Change from baseline in CHE-related Itch Numerical Rating Scale (NRS) score (weekly average) Up to Week 32 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).
Time to ≥ 2-point improvement from baseline in CHE-related Pain NRS score. Up to Week 32 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.
Proportion of Participants with HECSI-75 Weeks 2, 8, 16 and 32 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.
Proportion of participants with HECSI-90 Weeks 2, 8, 16, and 32 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.
Proportion of participants with a ≥ 4-point improvement in chronic hand eczema (CHE) related Itch NRS score Week 16 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.
Time to ≥ 4-point improvement from baseline in CHE-related Itch NRS score Up to Week 32 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.
Proportion of participants achieving an IGA-CHE-TS from baseline Up to Week 32 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.
Proportion of participants with each score on the PGIC Up to Week 32 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.
Proportion of Participants with a score of either 1 or 2 on the PGIC Up to Week 32 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.
Change from baseline in CHE-related Pain NRS score (weekly average) Up to Week 32 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).
Mean Patient Global Impression of Change (PGIC) score Up to Week 32 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.
Percentage change in Hand Eczema Severity Index (HECSI) Week 16 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.
Trial Locations
- Locations (48)
Southwest Skin Specialists Phoenix Biltmore
🇺🇸Phoenix, Arizona, United States
Raoof Md Encino
🇺🇸Encino, California, United States
First Oc Dermatology
🇺🇸Fountain Valley, California, United States
Marvel Clinical Research Llc
🇺🇸Huntington Beach, California, United States
Well Pharma Medical Research Corporation
🇺🇸Miami, Florida, United States
Psoriasis Treatment Center of South Florida
🇺🇸Pembroke Pines, Florida, United States
Lenus Research Medical Group, Llc
🇺🇸Sweetwater, Florida, United States
Delricht Research
🇺🇸New Orleans, Louisiana, United States
Arlington Dermatology
🇺🇸Rolling Meadows, Illinois, United States
Midwest Allergy Sinus Asthma, Sc
🇺🇸Springfield, Illinois, United States
Scroll for more (38 remaining)Southwest Skin Specialists Phoenix Biltmore🇺🇸Phoenix, Arizona, United States