Trial Outcomes & Findings for Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (NCT NCT04871711)

Last Updated: 2025-04-08

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE3

Target enrollment

487 participants

Primary outcome timeframe

16 weeks

Results posted on

2025-04-08

Participant Flow

Participant milestones

Participant milestones
Measure	Delgocitinib Cream 20 mg/g Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Overall Study STARTED	325	162
Overall Study COMPLETED	305	141
Overall Study NOT COMPLETED	20	21

Reasons for withdrawal

Reasons for withdrawal
Measure	Delgocitinib Cream 20 mg/g Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Overall Study Withdrawal by Subject	11	5
Overall Study Lack of Efficacy	5	7
Overall Study Adverse Event	2	6
Overall Study Various reasons	2	1
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Data not available for 1 participant in the delgocitinib cream 20 mg/g group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks\> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks\> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.	Total n=487 Participants Total of all reporting groups
Age, Categorical <=18 years	0 Participants n=325 Participants	0 Participants n=162 Participants	0 Participants n=487 Participants
Age, Categorical Between 18 and 65 years	297 Participants n=325 Participants	154 Participants n=162 Participants	451 Participants n=487 Participants
Age, Categorical >=65 years	28 Participants n=325 Participants	8 Participants n=162 Participants	36 Participants n=487 Participants
Age, Continuous	44.3 years STANDARD_DEVIATION 14.3 • n=325 Participants	42.9 years STANDARD_DEVIATION 14.1 • n=162 Participants	43.8 years STANDARD_DEVIATION 14.3 • n=487 Participants
Sex: Female, Male Female	202 Participants n=325 Participants	104 Participants n=162 Participants	306 Participants n=487 Participants
Sex: Female, Male Male	123 Participants n=325 Participants	58 Participants n=162 Participants	181 Participants n=487 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	14 Participants n=325 Participants	4 Participants n=162 Participants	18 Participants n=487 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	292 Participants n=325 Participants	147 Participants n=162 Participants	439 Participants n=487 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	19 Participants n=325 Participants	11 Participants n=162 Participants	30 Participants n=487 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=325 Participants	0 Participants n=162 Participants	1 Participants n=487 Participants
Race (NIH/OMB) Asian	14 Participants n=325 Participants	5 Participants n=162 Participants	19 Participants n=487 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=325 Participants	0 Participants n=162 Participants	0 Participants n=487 Participants
Race (NIH/OMB) Black or African American	3 Participants n=325 Participants	1 Participants n=162 Participants	4 Participants n=487 Participants
Race (NIH/OMB) White	283 Participants n=325 Participants	144 Participants n=162 Participants	427 Participants n=487 Participants
Race (NIH/OMB) More than one race	2 Participants n=325 Participants	1 Participants n=162 Participants	3 Participants n=487 Participants
Race (NIH/OMB) Unknown or Not Reported	22 Participants n=325 Participants	11 Participants n=162 Participants	33 Participants n=487 Participants
Region of Enrollment Canada	65 Participants n=325 Participants	32 Participants n=162 Participants	97 Participants n=487 Participants
Region of Enrollment Poland	70 Participants n=325 Participants	35 Participants n=162 Participants	105 Participants n=487 Participants
Region of Enrollment United Kingdom	20 Participants n=325 Participants	4 Participants n=162 Participants	24 Participants n=487 Participants
Region of Enrollment Italy	31 Participants n=325 Participants	14 Participants n=162 Participants	45 Participants n=487 Participants
Region of Enrollment France	49 Participants n=325 Participants	32 Participants n=162 Participants	81 Participants n=487 Participants
Region of Enrollment Germany	90 Participants n=325 Participants	45 Participants n=162 Participants	135 Participants n=487 Participants
Baseline IGA-CHE score 0 - Clear	0 Participants n=325 Participants	0 Participants n=162 Participants	0 Participants n=487 Participants
Baseline IGA-CHE score 1 - Almost clear	0 Participants n=325 Participants	0 Participants n=162 Participants	0 Participants n=487 Participants
Baseline IGA-CHE score 2 - Mild	0 Participants n=325 Participants	0 Participants n=162 Participants	0 Participants n=487 Participants
Baseline IGA-CHE score 3 - Moderate	218 Participants n=325 Participants	109 Participants n=162 Participants	327 Participants n=487 Participants
Baseline IGA-CHE score 4 - Severe	107 Participants n=325 Participants	53 Participants n=162 Participants	160 Participants n=487 Participants
Baseline HECSI score	77.6 units on a scale STANDARD_DEVIATION 46.4 • n=325 Participants	77.3 units on a scale STANDARD_DEVIATION 53.6 • n=162 Participants	77.5 units on a scale STANDARD_DEVIATION 48.9 • n=487 Participants
Baseline HESD itch score (weekly average)	7.13 units on a scale STANDARD_DEVIATION 1.64 • n=324 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	7.23 units on a scale STANDARD_DEVIATION 1.69 • n=162 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	7.16 units on a scale STANDARD_DEVIATION 1.66 • n=486 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.
Baseline HESD pain score (weekly average)	6.83 units on a scale STANDARD_DEVIATION 2.00 • n=324 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	6.84 units on a scale STANDARD_DEVIATION 2.03 • n=162 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	6.83 units on a scale STANDARD_DEVIATION 2.01 • n=486 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.
Baseline HESD score (weekly average)	7.15 units on a scale STANDARD_DEVIATION 1.66 • n=324 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	7.16 units on a scale STANDARD_DEVIATION 1.68 • n=162 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	7.16 units on a scale STANDARD_DEVIATION 1.67 • n=486 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.
Baseline DLQI score	12.8 units on a scale STANDARD_DEVIATION 6.0 • n=321 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	12.9 units on a scale STANDARD_DEVIATION 6.8 • n=158 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	12.8 units on a scale STANDARD_DEVIATION 6.3 • n=479 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.
Baseline HEIS score	2.50 units on a scale STANDARD_DEVIATION 0.77 • n=321 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	2.49 units on a scale STANDARD_DEVIATION 0.89 • n=158 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	2.49 units on a scale STANDARD_DEVIATION 0.81 • n=479 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.
Baseline HEIS PDAL score	2.57 units on a scale STANDARD_DEVIATION 0.89 • n=321 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	2.57 units on a scale STANDARD_DEVIATION 0.94 • n=158 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	2.57 units on a scale STANDARD_DEVIATION 0.91 • n=479 Participants • Data not available for 4 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.

PRIMARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With IGA-CHE TS at Week 16	64 Participants	16 Participants

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=323 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=161 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16	152 Participants	37 Participants

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=309 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=156 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16	146 Participants	38 Participants

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With IGA-CHE TS at Week 8	74 Participants	17 Participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With IGA-CHE TS at Week 4	50 Participants	8 Participants

SECONDARY outcome

Timeframe: 8 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=323 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=161 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8	138 Participants	35 Participants

SECONDARY outcome

Timeframe: 4 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=323 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=161 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4	99 Participants	18 Participants

SECONDARY outcome

Timeframe: 2 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=323 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=161 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2	50 Participants	10 Participants

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=309 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=156 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8	123 Participants	27 Participants

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=309 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=156 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4	92 Participants	16 Participants

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=291 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=149 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16	143 Participants	41 Participants

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=291 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=149 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8	134 Participants	33 Participants

SECONDARY outcome

Timeframe: 4 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=291 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=149 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4	100 Participants	22 Participants

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With HECSI-90 at Week 16	96 Participants	20 Participants

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With HECSI-75 at Week 16	160 Participants	38 Participants

SECONDARY outcome

Timeframe: 8 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Participants With HECSI-75 at Week 8	163 Participants	42 Participants

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Percentage Change in HECSI Score From Baseline to Week 16	-56.5 percentage change Standard Error 3.4	-21.2 percentage change Standard Error 4.8

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=321 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=158 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in DLQI Score From Baseline to Week 16	-7.6 score on a scale Standard Error 0.3	-3.9 score on a scale Standard Error 0.4

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=324 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in HESD Score (Weekly Average) From Baseline to Week 16	-3.4 score on a scale Standard Error 0.1	-1.7 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=324 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in HESD Itch Score (Weekly Average) From Baseline to Week 16	-3.6 score on a scale Standard Error 0.2	-1.9 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=324 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in HESD Pain Score (Weekly Average) From Baseline to Week 16	-3.4 score on a scale Standard Error 0.2	-1.8 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=321 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=158 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in HEIS Score From Baseline to Week 16	-1.46 score on a scale Standard Error 0.05	-0.82 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 16 weeks

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=321 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=158 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Change in HEIS PDAL Score From Baseline to Week 16	-1.46 score on a scale Standard Error 0.06	-0.86 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 16 weeks

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=305 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=148 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Reduction of DLQI Score of ≥4 Points From Baseline at Week 16	227 Participants	74 Participants

SECONDARY outcome

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

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.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=325 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=162 Participants Twice-daily topical application for 16 weeks \> \> Cream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Number of Treatment-emergent AEs From Baseline up to End of Trial	308 Adverse events	161 Adverse events

Adverse Events

Delgocitinib |20 mg/g

Serious events: 6 serious events

Other events: 69 other events

Deaths: 0 deaths

Vehicle|

Serious events: 3 serious events

Other events: 42 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delgocitinib \|20 mg/g n=325 participants at risk Twice-daily topical application for 16 weeks	Vehicle\| n=162 participants at risk Twice-daily topical application for 16 weeks
Gastrointestinal disorders Inguinal hernia	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Infections and infestations Keratitis bacterial	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Infections and infestations Tonsillitis	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Injury, poisoning and procedural complications Post procedural haemorrhage	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Musculoskeletal and connective tissue disorders Intervertebral disc protrusion	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Musculoskeletal and connective tissue disorders Osteoarthritis	0.00% 0/325 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.62% 1/162 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Gallbladder adenocarcinoma	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Nervous system disorders Generalised tonic-clonic seizure	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.00% 0/162 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Skin and subcutaneous tissue disorders Dermatitis atopic	0.00% 0/325 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.62% 1/162 • Number of events 2 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Vascular disorders Venous thrombosis	0.00% 0/325 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	0.62% 1/162 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])

Other adverse events

Other adverse events
Measure	Delgocitinib \|20 mg/g n=325 participants at risk Twice-daily topical application for 16 weeks	Vehicle\| n=162 participants at risk Twice-daily topical application for 16 weeks
Immune system disorders Allergy to metals	2.2% 7/325 • Number of events 7 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	1.9% 3/162 • Number of events 3 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Infections and infestations COVID-19	10.8% 35/325 • Number of events 35 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	8.6% 14/162 • Number of events 14 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Infections and infestations Nasopharyngitis	7.1% 23/325 • Number of events 25 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	8.6% 14/162 • Number of events 16 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Nervous system disorders Headache	2.8% 9/325 • Number of events 13 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	2.5% 4/162 • Number of events 6 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Skin and subcutaneous tissue disorders Dermatitis contact	1.2% 4/325 • Number of events 4 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	2.5% 4/162 • Number of events 4 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])
Skin and subcutaneous tissue disorders Hand dermatitis	0.31% 1/325 • Number of events 1 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])	4.3% 7/162 • Number of events 10 • 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403])

Additional Information

Disclosure Specialist

LEO Pharma A/S

Phone: +45 44945888

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee LEO Pharma seeks publication of all Phase 3 clinical trials in peer-reviewed journals within 18 months of trial completion, regardless of whether the findings are positive or negative. If there is no multi-center publication within 18 months after the clinical trial has been completed or terminated at all trial sites, the investigator has the right to publish the results from the clinical trial generated by the investigator.
Publication restrictions are in place

Restriction type: OTHER