Hand Eczema
Conditions
Keywords
eczema, chronic hand eczema (CHE), dermatitis, skin disease, JAK inhibitor
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).
Interventions
DRUGRuxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUGVehicle
Vehicle cream is a topical formulation applied as a thin film to affected areas.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)
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.
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
| 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. |
| 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). |
| 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). |
| 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 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
Countries
Canada, Czechia, Germany, Poland, Spain, United States
Outcome results
None listed