CompletedNCT04871711DELTA 1Updated Apr 8, 2025Results posted

Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema

A Phase 3 interventional study of Delgocitinib cream and Cream vehicle in Chronic Hand Eczema, sponsored by LEO Pharma. Completed at 54 sites in 6 countries. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-04-08.

Sponsored by LEO Pharma · Phase 3, Interventional, and Treatment

Phase: Phase 3
Study type: Interventional
Enrollment: 487
Allocation: Randomized
Ages: 18 Years and older
Sex: All

Study summary

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.

Conditions studied

Chronic Hand Eczema

Browse trials for

Eczema 1,084

In context

Eczema

1,084 studies on the registry are indexed under Eczema; 137 are open to participants now.

This study's enrollment of 487 is above the median of 80 across 861 interventional studies indexed under Eczema.

Browse Eczema studies →

Lead sponsor

LEO Pharma is the lead sponsor of 221 studies on the registry; 5 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 24 (77%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 18 Years and older
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

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.

Study design

Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 487 participants (actual)

Study arms

Experimental
Delgocitinib cream 20 mg/g
Twice-daily topical application for 16 weeks
Drug: Delgocitinib cream
Placebo comparator
Cream vehicle
Twice-daily topical application for 16 weeks
Drug: Cream vehicle

Interventions

DrugDelgocitinib cream
Cream for topical application
Also known as: LEO 124249 cream
DrugCream vehicle
The cream vehicle is similar to the delgocitinib cream\> except that it does not contain any active ingredient.

What researchers measure

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 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.
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 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
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: 4 weeks
Number of Participants With Reduction of HESD Itch 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 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Time frame: 8 weeks
Number of Participants With Reduction of HESD Itch 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 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points.
Time frame: 4 weeks
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2
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.
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
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.
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
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.
Time frame: 16 weeks
Change in HESD Pain 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. This endpoint will only assess the 'pain' component.
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 domain scores in Hand Eczema Impact Scale (HEIS) assessing the participant's perceived impact on their daily activities. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). HEIS PDAL score is the average of the 3 items.
Time frame: 16 weeks
Reduction of DLQI Score of ≥4 Points From Baseline at 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. This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points.
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])

Results

Posted Sep 23, 2024

Participant flow

Participant flow — Overall Study
Milestone	Delgocitinib Cream 20 mg/g	Cream Vehicle
Started	325	162
Completed	305	141
Not completed	20	21
Withdrew: Withdrawal by subject	11	5
Withdrew: Lack of efficacy	5	7
Withdrew: Adverse event	2	6
Withdrew: Various reasons	2	1
Withdrew: Lost to follow-up	0	2

Outcome measures

PrimaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With IGA-CHE TS at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With IGA-CHE TS at Week 16	64	16

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.006 (5% significance level (two-sided).) · Risk difference (rd): 9.8 · 95% CI 3.6 to 16.1Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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.

Time frame:: 16 weeks
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16	152	37

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 24.1 · 95% CI 15.5 to 32.6Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16	146	38

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 5% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 22.8 · 95% CI 14.0 to 31.7Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With IGA-CHE TS at Week 8
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With IGA-CHE TS at Week 8	74	17

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 12.3 · 95% CI 5.7 to 18.9Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber of Participants With IGA-CHE TS at Week 4

Time frame:: 4 weeks
Reported as:: Count of participants · Participants

Number of Participants With IGA-CHE TS at Week 4
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With IGA-CHE TS at Week 4	50	8

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 10.4 · 95% CI 5.3 to 15.6Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

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

Time frame:: 8 weeks
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8	138	35

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 21.0 · 95% CI 12.6 to 29.4Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

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

Time frame:: 4 weeks
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4	99	18

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 19.5 · 95% CI 12.5 to 26.5Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

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

Time frame:: 2 weeks
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2	50	10

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = 0.004 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 9.3 · 95% CI 3.8 to 14.7Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8	123	27

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 22.5 · 95% CI 14.4 to 30.6Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4	92	16

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 19.5 · 95% CI 12.5 to 26.5Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16	143	41

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 21.7 · 95% CI 12.4 to 30.9Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8	134	33

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 23.9 · 95% CI 15.2 to 32.7Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4	100	22

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 4% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 19.6 · 95% CI 11.8 to 27.5Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With HECSI-90 at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With HECSI-90 at Week 16	96	20

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 17.2 · 95% CI 10.1 to 24.3Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With HECSI-75 at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With HECSI-75 at Week 16	160	38

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 25.7 · 95% CI 17.2 to 34.3Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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
Reported as:: Count of participants · Participants

Number of Participants With HECSI-75 at Week 8
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Participants With HECSI-75 at Week 8	163	42

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 24.2 · 95% CI 15.5 to 33.0Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryPercentage Change in HECSI Score From Baseline to Week 16

Time frame:: 16 weeks
Reported as:: Least squares mean · percentage change

Percentage Change in HECSI Score From Baseline to Week 16
percentage change	Delgocitinib Cream 20 mg/g	Cream Vehicle
Percentage Change in HECSI Score From Baseline to Week 16	-56.5 ± 3.4	-21.2 ± 4.8

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -35.2 · 95% CI -46.7 to -23.8Adjusted for treatment, region, baseline IGA-CHE score, and baseline HECSI score.

SecondaryChange 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
Reported as:: Least squares mean · score on a scale

Change in DLQI Score From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in DLQI Score From Baseline to Week 16	-7.6 ± 0.3	-3.9 ± 0.4

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -3.6 · 95% CI -4.7 to -2.6Adjusted for treatment, region, baseline IGA-CHE score, and baseline DLQI score.

SecondaryChange 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
Reported as:: Least squares mean · score on a scale

Change in HESD Score (Weekly Average) From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in HESD Score (Weekly Average) From Baseline to Week 16	-3.4 ± 0.1	-1.7 ± 0.2

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -1.7 · 95% CI -2.2 to -1.2Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD score.

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

Time frame:: 16 weeks
Reported as:: Least squares mean · score on a scale

Change in HESD Itch Score (Weekly Average) From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in HESD Itch Score (Weekly Average) From Baseline to Week 16	-3.6 ± 0.2	-1.9 ± 0.2

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -1.7 · 95% CI -2.3 to -1.2Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD itch score.

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

Time frame:: 16 weeks
Reported as:: Least squares mean · score on a scale

Change in HESD Pain Score (Weekly Average) From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in HESD Pain Score (Weekly Average) From Baseline to Week 16	-3.4 ± 0.2	-1.8 ± 0.2

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -1.6 · 95% CI -2.1 to -1.0Adjusted for treatment, region, baseline IGA-CHE score, and baseline HESD pain score.

SecondaryChange 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
Reported as:: Least squares mean · score on a scale

Change in HEIS Score From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in HEIS Score From Baseline to Week 16	-1.46 ± 0.05	-0.82 ± 0.08

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -0.64 · 95% CI -0.83 to -0.45Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS score.

SecondaryChange in HEIS PDAL Score From Baseline to Week 16

Proximal Daily Activity Limitations (PDAL) is one of the domain scores in Hand Eczema Impact Scale (HEIS) assessing the participant's perceived impact on their daily activities. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). HEIS PDAL score is the average of the 3 items.

Time frame:: 16 weeks
Reported as:: Least squares mean · score on a scale

Change in HEIS PDAL Score From Baseline to Week 16
score on a scale	Delgocitinib Cream 20 mg/g	Cream Vehicle
Change in HEIS PDAL Score From Baseline to Week 16	-1.46 ± 0.06	-0.86 ± 0.08

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · ANCOVA · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Mean difference (net): -0.6 · 95% CI -0.79 to -0.40Adjusted for treatment, region, baseline IGA-CHE score, and baseline HEIS PDAL score.

SecondaryReduction of DLQI Score of ≥4 Points From Baseline at Week 16

Time frame:: 16 weeks
Reported as:: Count of participants · Participants

Reduction of DLQI Score of ≥4 Points From Baseline at Week 16
Participants	Delgocitinib Cream 20 mg/g	Cream Vehicle
Reduction of DLQI Score of ≥4 Points From Baseline at Week 16	227	74

Statistical analysis

Delgocitinib Cream 20 mg/g vs Cream Vehicle · Cochran-Mantel-Haenszel · p = <0.001 (Evaluated at 1% significance level (two-sided) using hierarchical tests, alpha splitting and alpha recycling controlling overall type 1 error at 5% (two-sided).) · Risk difference (rd): 24.5 · 95% CI 15.0 to 33.9Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score.

SecondaryNumber 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])
Reported as:: Number · Adverse events

Number of Treatment-emergent AEs From Baseline up to End of Trial
Adverse events	Delgocitinib Cream 20 mg/g	Cream Vehicle
Number of Treatment-emergent AEs From Baseline up to End of Trial	308	161

Adverse events

Collected over 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]). Non-serious events are listed at a 2% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Delgocitinib \|20 mg/g	0/325 (0%)	6/325 (1.8%)	69/325 (21.2%)
Vehicle\|	0/162 (0%)	3/162 (1.9%)	42/162 (25.9%)

Most frequent serious events

Most frequent serious events
Event	Delgocitinib \|20 mg/g	Vehicle\|
OsteoarthritisMusculoskeletal and connective tissue disorders	0/325	1/162
Dermatitis atopicSkin and subcutaneous tissue disorders	0/325	1/162
Venous thrombosisVascular disorders	0/325	1/162
Inguinal herniaGastrointestinal disorders	1/325	0/162
Keratitis bacterialInfections and infestations	1/325	0/162
TonsillitisInfections and infestations	1/325	0/162
Post procedural haemorrhageInjury, poisoning and procedural complications	1/325	0/162
Intervertebral disc protrusionMusculoskeletal and connective tissue disorders	1/325	0/162
Gallbladder adenocarcinomaNeoplasms benign, malignant and unspecified (incl cysts and polyps)	1/325	0/162
Generalised tonic-clonic seizureNervous system disorders	1/325	0/162

Most frequent other events

Most frequent other events
Event	Delgocitinib \|20 mg/g	Vehicle\|
COVID-19Infections and infestations	35/325	14/162
NasopharyngitisInfections and infestations	23/325	14/162
Hand dermatitisSkin and subcutaneous tissue disorders	1/325	7/162
HeadacheNervous system disorders	9/325	4/162
Dermatitis contactSkin and subcutaneous tissue disorders	4/325	4/162
Allergy to metalsImmune system disorders	7/325	3/162

Baseline characteristics

Age, Categorical
Age, Categorical(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
<=18 years	0	0	0
Between 18 and 65 years	297	154	451
>=65 years	28	8	36

Age, Continuous
Age, Continuous(years)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
Mean	44.3 ± 14.3	42.9 ± 14.1	43.8 ± 14.3

Sex: Female, Male
Sex: Female, Male(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
Female	202	104	306
Male	123	58	181

Ethnicity (NIH/OMB)
Ethnicity (NIH/OMB)(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
Hispanic or Latino	14	4	18
Not Hispanic or Latino	292	147	439
Unknown or Not Reported	19	11	30

Race (NIH/OMB)
Race (NIH/OMB)(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
American Indian or Alaska Native	1	0	1
Asian	14	5	19
Native Hawaiian or Other Pacific Islander	0	0	0
Black or African American	3	1	4
White	283	144	427
More than one race	2	1	3
Unknown or Not Reported	22	11	33

Region of Enrollment
Region of Enrollment(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
Canada	65	32	97
Poland	70	35	105
United Kingdom	20	4	24
Italy	31	14	45
France	49	32	81
Germany	90	45	135

Baseline IGA-CHE score
Baseline IGA-CHE score(Participants)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
0 - Clear	0	0	0
1 - Almost clear	0	0	0
2 - Mild	0	0	0
3 - Moderate	218	109	327
4 - Severe	107	53	160

Baseline HECSI score
Baseline HECSI score(units on a scale)	Delgocitinib Cream 20 mg/g	Cream Vehicle	Total
Mean	77.6 ± 46.4	77.3 ± 53.6	77.5 ± 48.9

6 further baseline measures are reported on the registry.

Study locations

54 sites

LEO Investigational Site
Calgary, Alberta T2J 7E1, Canada
LEO Investigational Site
Calgary, Alberta T3E 0B2, Canada
LEO Investigational Site
Edmonton, Alberta T5J 3S9, Canada
LEO Investigational Site
Edmonton, Alberta T6G 1C3, Canada
LEO Investigational Site
Red Deer, Alberta T4P-1K4, Canada
LEO Investigational Site
Kingston, Ontario K7L 2V7, Canada
LEO Investigational Site
London, Ontario N6A 3H7, Canada
LEO Investigational Site
Markham, Ontario L3P 1X3, Canada
LEO Investigational Site
Toronto, Ontario M3H 5Y8, Canada
LEO Investigational Site
Montreal, Quebec H2X 2V1, Canada
LEO Investigational Site
Nice, Alpes-Maritimes 06202, France
LEO Investigational Site
Reims, Ardennes 51100, France
LEO Investigational Site
Nantes, Loire-Atlantique 6 44093, France
LEO Investigational Site
Vandoeuvre-les-Nancy, Meurthe-et-Moselle 54511, France
LEO Investigational Site
Lille, Nord 59000, France
LEO Investigational Site
Le Mans, Sarthe 72037, France
LEO Investigational Site
Bordeaux, 33000, France
LEO Investigational Site
Dijon, 21000, France
LEO Investigational Site
Lorient, 56322, France
LEO Investigational Site
Martigues, 13500, France
LEO Investigational Site
Nice, 06000, France
LEO Investigational Site
Paris, 75014, France
LEO Investigational Site
Toulouse, 31000, France
LEO Investigational Site
Berlin, 10117, Germany
LEO Investigational Site
Dresden, 01307, Germany
LEO Investigational Site
Gera, 07548, Germany
LEO Investigational Site
Göttingen, 37073, Germany
LEO Investigational Site
Hamburg, 22391, Germany
LEO Investigational Site
Haßfurt, 97437, Germany
LEO Investigational Site
Mainz, 55128, Germany
LEO Investigational Site
Memmingen, 87700, Germany
LEO Investigational Site
München, 80802, Germany
LEO Investigational Site
Osnabrück, 49074, Germany
LEO Investigational Site
Brescia, 25123, Italy
LEO Investigational Site
L'Aquila, 67100, Italy
LEO Investigational Site
Milano, 20122, Italy
LEO Investigational Site
Perugia, 06134, Italy
LEO Investigational Site
Roma, 00168, Italy
LEO Investigational Site
Vicenza, 36100, Italy
LEO Investigational Site
Białystok, 15-794, Poland
LEO Investigational Site
Gdansk, 80-546, Poland
LEO Investigational Site
Krakow, 30-033, Poland
LEO Investigational Site
Kraków, 31-011, Poland
LEO Investigational Site
Lodz, 90-436, Poland
LEO Investigational Site
Lublin, 20-081, Poland
LEO Investigational Site
Osielsko, 86-031, Poland
LEO Investigational Site
Warszawa, 02-507, Poland
LEO Investigational Site
Warszawa, 02-953, Poland
LEO Investigational Site
Salford, Greater Manchester M6 8HD, United Kingdom
LEO Investigational Site
Leicester, Leicestershire LE1 5WW, United Kingdom
LEO Investigational Site
London, Leytonstone E11 1NR, United Kingdom
LEO Investigational Site
Middlesborough, North Yorkshire TS4 3BW, United Kingdom
LEO Investigational Site
Redhill, Surrey RH1 5RH, United Kingdom
LEO Investigational Site
London, SE1 9RT, United Kingdom

References and documents

Publications

Bissonnette R, Warren RB, Pinter A, Agner T, Gooderham M, Schuttelaar MLA, Crepy MN, Stingeni L, Serra-Baldrich E, Baranowski K, Korn S, Kurvits M, Plohberger U, Strange Vest N, Schliemann S; trial investigators. Efficacy and safety of delgocitinib cream in adults with moderate to severe chronic hand eczema (DELTA 1 and DELTA 2): results from multicentre, randomised, controlled, double-blind, phase 3 trials. Lancet. 2024 Aug 3;404(10451):461-473. doi: 10.1016/S0140-6736(24)01027-4. Epub 2024 Jul 18. PubMed 39033766 ↗

Study documents

Protocol and statistical analysis plan · Aug 20, 2021

Documents are hosted by the registry — open the source record to download them.

Individual participant data

Plan to share: No

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on Apr 8, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT04871711
Lead sponsor: LEO Pharma
Responsible party: Sponsor
First posted: May 4, 2021
Start date: May 10, 2021
Primary completion: Oct 31, 2022
Completion: Oct 31, 2022
Results posted: Sep 23, 2024
Last update: Apr 8, 2025

Study contacts

Medical Expert

study director · LEO Pharma

Oversight

Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: No

View the source record on ClinicalTrials.gov ↗

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