Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2)

LEO Pharma473 enrolled

Overview

This was a 16-week study in adult participants with chronic hand eczema (CHE). The participants visited the clinic regularly to have the study doctor assess their CHE and to answer questions about itch, pain, CHE symptoms, and quality of life. The purpose was to assess how delgocitinib cream works to treat CHE when compared to a placebo cream with no active substance.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

473

Conditions

Chronic Hand Eczema

Interventions

Delgocitinib creamDRUG

Cream for topical application

Cream vehicleDRUG

The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Main inclusion criteria: * Diagnosis of CHE, defined as hand eczema that has persisted for more than 3 months or returned twice or more within the last 12 months. * Disease severity graded as moderate to severe at screening and baseline according to Investigator's Global Assessment for chronic hand eczema (IGA-CHE) (i.e. an IGA-CHE score of 3 or 4). * Hand Eczema Symptom Diary (HESD) itch score (weekly average) of ≥4 points at baseline. * Participants who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks). * Participants adherent to standard non-medicated skin care including avoidance of known and relevant irritants and allergens. Main exclusion criteria: * Concurrent skin diseases on the hands, e.g. tinea manuum. * Active atopic dermatitis requiring medical treatment in regions other than the hands and feet. * Active psoriasis on any part of the body. * Hyperkeratotic hand eczema in combination with a history of psoriasis on any part of the body. * Clinically significant infection on the hands. * Systemic treatment with immunosuppressive drugs, immunomodulating drugs, retinoids, or corticosteroids within 28 days prior to baseline. * Use of tanning beds, phototherapy, or bleach baths on the hands within 28 days prior to baseline. * Previous or current treatment with Janus kinase (JAK) inhibitors (including delgocitinib/LEO 124249), systemic or topical. * Cutaneously applied treatment with immunomodulators or TCS on the hands within 14 days prior to baseline. * Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline. * Other transdermal or cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline. * Cutaneously applied treatments in regions other than the hands, which could interfere with clinical trial evaluations or pose a safety concern within 7 days prior to baseline. * Treatment with any marketed biological therapy or investigational biologic agents: * Any cell-depleting agents: within 6 months prior to baseline, or until lymphocyte count returns to normal, whichever is longer. * Other biologics: within 3 months or 5 half-lives, whichever is longer, prior to baseline. * Clinically significant infection within 28 days prior to baseline which, in the opinion of the investigator, may compromise the safety of the participant in the trial, interfere with evaluation of the IMP, or reduce the participant's ability to participate in the trial. * History of any known primary immunodeficiency disorder including a positive human immunodeficiency virus (HIV) test at screening, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report. * Any disorder which is not stable and could: * Affect the safety of the participant throughout the trial. * Impede the participant's ability to complete the trial. * Positive hepatitis B surface antigen or hepatitis C virus antibody serology at screening.

Locations (50)

Outcomes

Primary Outcomes

Number of Participants With IGA-CHE TS at 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.

Time frame: 16 weeks

Secondary Outcomes

Number of Participants With IGA-CHE TS at Week 8

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 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: 8 weeks

Number of Participants With IGA-CHE TS at Week 4

Time frame: 4 weeks

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.

Data from ClinicalTrials.gov

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LEO Investigational Site

Brussels, Belgium

LEO Investigational Site

Edegem, Belgium

LEO Investigational Site

Ghent, Belgium

LEO Investigational Site

Kortrijk, Belgium

LEO Investigational Site

Leuven, Belgium

LEO Investigational Site

Loverval, Belgium

LEO Investigational Site

Maldegem, Belgium

LEO Investigational Site

Surrey, British Columbia, Canada

LEO Investigational Site

Vancouver, British Columbia, Canada

LEO Investigational Site

Fredericton, New Brunswick, Canada

...and 40 more locations

Time frame: 16 weeks

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

Time frame: 16 weeks

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8

Time frame: 8 weeks

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4

Time frame: 4 weeks

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2

Time frame: 2 weeks

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

Time frame: 8 weeks

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms. This endpoint will be evaluated among participants with a baseline HESD score (weekly average) ≥4 points.

Time frame: 4 weeks

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

Time frame: 16 weeks

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

Time frame: 8 weeks

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. This endpoint will only assess the 'pain' component and will be evaluated among participants with a baseline HESD pain score (weekly average) ≥4 points.

Time frame: 4 weeks

Number of Participants With HECSI-90 at 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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-90 is defined as at least 90% improvement in HECSI score from baseline.

Time frame: 16 weeks

Number of Participants With HECSI-75 at 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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.

Time frame: 16 weeks

Number of Participants With HECSI-75 at Week 8

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. The HECSI score will range from 0 (lowest possible score) to 360 (highest possible score), with a higher score indicating greater severity. HECSI-75 is defined as at least 75% improvement in HECSI score from baseline.

Time frame: 8 weeks

Percentage Change in HECSI Score From Baseline to Week 16

Time frame: 16 weeks

Change in DLQI Score From Baseline to Week 16

The Dermatology Life Quality Index (DLQI) is a validated questionnaire consisting of 10 items addressing the participant's perception of the impact of their skin disease on different aspects of their quality of life over the last week. The DLQI score is the sum of the 10 items (score ranging from 0 to 30); a high score is indicative of a poor quality of life.

Time frame: 16 weeks

Change in HESD Score (Weekly Average) From Baseline to Week 16

The Hand Eczema Symptom Diary (HESD) is an eDiary in which participants will assess the worst severity of 6 individual signs and symptoms of CHE over the past 24 hours using an 11-point numeric rating scale with anchors of 0 ='no (symptom)' and 10 ='severe (symptom)' throughout the trial on a daily basis. The HESD score is derived as the average of the 6 signs and symptoms.

Time frame: 16 weeks

Change in HESD Itch Score (Weekly Average) From Baseline to Week 16

Time frame: 16 weeks

Change in HESD Pain Score (Weekly Average) From Baseline to Week 16

Time frame: 16 weeks

Change in HEIS Score From Baseline to Week 16

The Hand Eczema Impact Scale (HEIS) addresses 9 items within the following domains: Proximal Daily Activity Limitations (PDAL), embarrassment with the appearance of the hands, frustration with CHE, sleep, work, and physical functioning. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). The HEIS score is the average of the 9 items.

Time frame: 16 weeks

Change in HEIS PDAL Score From Baseline to Week 16

Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).

Time frame: 16 weeks

Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16

Time frame: 16 weeks

Number of Treatment-emergent AEs From Baseline up to End of Trial

An adverse event (AE) were considered treatment emergent if started after the first application of investigational medicinal product (IMP), or if started before the first application of IMP and worsened in severity after first dose of IMP. End of trial was defined as Week 16 for participants who rolled over to the long-term extension trial and as Week 18 for participants who did not roll over.

Time frame: 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])