Trial Outcomes & Findings for Efficacy and Safety of Delgocitinib Cream in Adults With Moderate to Severe Chronic Hand Eczema (DELTA 2) (NCT NCT04872101)

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

473 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	314	159
Overall Study COMPLETED	291	122
Overall Study NOT COMPLETED	23	37

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	10	16
Overall Study Lack of Efficacy	6	14
Overall Study Adverse Event	1	6
Overall Study Lost to Follow-up	2	1
Overall Study Pregnancy	2	0
Overall Study Prohibited Medication	1	0
Overall Study Not dosed	1	0

Baseline Characteristics

Data not available for 4 participants in the delgocitinib cream 20 mg/g group.

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Delgocitinib Cream 20 mg/g n=314 Participants Twice-daily topical application for 16 weeks\> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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=473 Participants Total of all reporting groups
Baseline DLQI score	12.1 units on a scale STANDARD_DEVIATION 6.2 • n=310 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	12.2 units on a scale STANDARD_DEVIATION 6.6 • n=159 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	12.1 units on a scale STANDARD_DEVIATION 6.3 • n=469 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.
Age, Categorical <=18 years	0 Participants n=314 Participants	0 Participants n=159 Participants	0 Participants n=473 Participants
Age, Categorical Between 18 and 65 years	286 Participants n=314 Participants	150 Participants n=159 Participants	436 Participants n=473 Participants
Age, Categorical >=65 years	28 Participants n=314 Participants	9 Participants n=159 Participants	37 Participants n=473 Participants
Age, Continuous	45.3 years STANDARD_DEVIATION 14.6 • n=314 Participants	42.6 years STANDARD_DEVIATION 14.3 • n=159 Participants	44.4 years STANDARD_DEVIATION 14.5 • n=473 Participants
Sex: Female, Male Female	204 Participants n=314 Participants	108 Participants n=159 Participants	312 Participants n=473 Participants
Sex: Female, Male Male	110 Participants n=314 Participants	51 Participants n=159 Participants	161 Participants n=473 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	2 Participants n=314 Participants	5 Participants n=159 Participants	7 Participants n=473 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	310 Participants n=314 Participants	152 Participants n=159 Participants	462 Participants n=473 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	2 Participants n=314 Participants	2 Participants n=159 Participants	4 Participants n=473 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=314 Participants	0 Participants n=159 Participants	0 Participants n=473 Participants
Race (NIH/OMB) Asian	8 Participants n=314 Participants	7 Participants n=159 Participants	15 Participants n=473 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=314 Participants	0 Participants n=159 Participants	1 Participants n=473 Participants
Race (NIH/OMB) Black or African American	2 Participants n=314 Participants	1 Participants n=159 Participants	3 Participants n=473 Participants
Race (NIH/OMB) White	295 Participants n=314 Participants	146 Participants n=159 Participants	441 Participants n=473 Participants
Race (NIH/OMB) More than one race	1 Participants n=314 Participants	3 Participants n=159 Participants	4 Participants n=473 Participants
Race (NIH/OMB) Unknown or Not Reported	7 Participants n=314 Participants	2 Participants n=159 Participants	9 Participants n=473 Participants
Region of Enrollment Canada	64 participants n=314 Participants	33 participants n=159 Participants	97 participants n=473 Participants
Region of Enrollment Netherlands	13 participants n=314 Participants	11 participants n=159 Participants	24 participants n=473 Participants
Region of Enrollment Belgium	11 participants n=314 Participants	11 participants n=159 Participants	22 participants n=473 Participants
Region of Enrollment Poland	64 participants n=314 Participants	32 participants n=159 Participants	96 participants n=473 Participants
Region of Enrollment Denmark	19 participants n=314 Participants	3 participants n=159 Participants	22 participants n=473 Participants
Region of Enrollment Germany	98 participants n=314 Participants	49 participants n=159 Participants	147 participants n=473 Participants
Region of Enrollment Spain	45 participants n=314 Participants	20 participants n=159 Participants	65 participants n=473 Participants
Baseline IGA-CHE score 0 - Clear	0 Participants n=314 Participants	0 Participants n=159 Participants	0 Participants n=473 Participants
Baseline IGA-CHE score 1 - Almost clear	0 Participants n=314 Participants	0 Participants n=159 Participants	0 Participants n=473 Participants
Baseline IGA-CHE score 2 - Mild	0 Participants n=314 Participants	0 Participants n=159 Participants	0 Participants n=473 Participants
Baseline IGA-CHE score 3 - Moderate	239 Participants n=314 Participants	121 Participants n=159 Participants	360 Participants n=473 Participants
Baseline IGA-CHE score 4 - Severe	75 Participants n=314 Participants	38 Participants n=159 Participants	113 Participants n=473 Participants
Baseline HECSI score	64.3 units on a scale STANDARD_DEVIATION 37.9 • n=313 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	67.7 units on a scale STANDARD_DEVIATION 39.5 • n=159 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.	65.5 units on a scale STANDARD_DEVIATION 38.5 • n=472 Participants • Data not available for 1 participant in the delgocitinib cream 20 mg/g group.
Baseline HESD itch score (weekly average)	6.99 units on a scale STANDARD_DEVIATION 1.55 • n=312 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.98 units on a scale STANDARD_DEVIATION 1.51 • n=157 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.99 units on a scale STANDARD_DEVIATION 1.53 • n=469 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.
Baseline HESD pain score (weekly average)	6.62 units on a scale STANDARD_DEVIATION 1.81 • n=312 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.46 units on a scale STANDARD_DEVIATION 1.96 • n=157 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.56 units on a scale STANDARD_DEVIATION 1.86 • n=469 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.
Baseline HESD score (weekly average)	6.97 units on a scale STANDARD_DEVIATION 1.46 • n=312 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.91 units on a scale STANDARD_DEVIATION 1.51 • n=157 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.	6.95 units on a scale STANDARD_DEVIATION 1.47 • n=469 Participants • Data not available for 2 participants each in the delgocitinib cream 20 mg/g group and in the cream vehicle group.
Baseline HEIS score	2.42 units on a scale STANDARD_DEVIATION 0.79 • n=310 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	2.46 units on a scale STANDARD_DEVIATION 0.84 • n=159 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	2.43 units on a scale STANDARD_DEVIATION 0.80 • n=469 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.
Baseline HEIS PDAL score	2.54 units on a scale STANDARD_DEVIATION 0.90 • n=310 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	2.56 units on a scale STANDARD_DEVIATION 0.94 • n=159 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.	2.55 units on a scale STANDARD_DEVIATION 0.91 • n=469 Participants • Data not available for 4 participants in the delgocitinib cream 20 mg/g group.

PRIMARY outcome

Timeframe: 16 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	91 Participants	11 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

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=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	101 Participants	15 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	46 Participants	13 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 5 participant in the Delgocitinib cream 20 mg/g group and for 3 participants in the cream vehicle group.

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=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 Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16	146 Participants	31 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 6 participant in the Delgocitinib cream 20 mg/g group and for 6 participants in the cream vehicle group.

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=308 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=153 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	137 Participants	32 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data is not available for 5 participant in the Delgocitinib cream 20 mg/g group and for 3 participants in the cream vehicle group.

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 Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8	131 Participants	21 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Data is not available for 5 participant in the Delgocitinib cream 20 mg/g group and for 3 participants in the cream vehicle group.

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 Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4	94 Participants	19 Participants

SECONDARY outcome

Timeframe: 2 weeks

Population: Data is not available for 5 participant in the Delgocitinib cream 20 mg/g group and for 3 participants in the cream vehicle group.

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 Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2	40 Participants	10 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data is not available for 6 participant in the Delgocitinib cream 20 mg/g group and for 6 participants in the cream vehicle group.

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=308 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=153 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	115 Participants	19 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Data is not available for 6 participant in the Delgocitinib cream 20 mg/g group and for 6 participants in the cream vehicle group.

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=308 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=153 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	80 Participants	14 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 20 participant in the Delgocitinib cream 20 mg/g group and for 18 participants in the cream vehicle group.

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=294 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=141 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	32 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data is not available for 20 participant in the Delgocitinib cream 20 mg/g group and for 18 participants in the cream vehicle group.

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=294 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=141 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	124 Participants	18 Participants

SECONDARY outcome

Timeframe: 4 weeks

Population: Data is not available for 20 participant in the Delgocitinib cream 20 mg/g group and for 18 participants in the cream vehicle group.

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=294 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=141 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	91 Participants	15 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

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=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	97 Participants	14 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

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=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	155 Participants	29 Participants

SECONDARY outcome

Timeframe: 8 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

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=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	158 Participants	31 Participants

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	-58.9 percentage change Standard Error 3.2	-13.4 percentage change Standard Error 4.5

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.

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=310 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	-7.0 score on a scale Standard Error 0.3	-3.1 score on a scale Standard Error 0.5

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 2 participant in the Delgocitinib cream 20 mg/g group and for 2 participants in the cream vehicle group.

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=312 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=157 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	-3.2 score on a scale Standard Error 0.1	-1.4 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 2 participant in the Delgocitinib cream 20 mg/g group and for 2 participants in the cream vehicle group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=312 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=157 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	-3.4 score on a scale Standard Error 0.2	-1.4 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 2 participant in the Delgocitinib cream 20 mg/g group and for 2 participants in the cream vehicle group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=312 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=157 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	-3.3 score on a scale Standard Error 0.2	-1.3 score on a scale Standard Error 0.2

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.

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=310 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	-1.45 score on a scale Standard Error 0.06	-0.64 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.

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).

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=310 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	-1.48 score on a scale Standard Error 0.06	-0.66 score on a scale Standard Error 0.08

SECONDARY outcome

Timeframe: 16 weeks

Population: Data is not available for 15 participant in the Delgocitinib cream 20 mg/g group and for 6 participants in the cream vehicle group.

Outcome measures

Outcome measures
Measure	Delgocitinib Cream 20 mg/g n=299 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=153 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 DLQI Score of ≥4 Points From Baseline at Week 16	216 Participants	70 Participants

SECONDARY outcome

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

Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.

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=313 Participants Twice-daily topical application for 16 weeks \> \> Delgocitinib cream: Cream for topical application	Cream Vehicle n=159 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	269 Adverse events	145 Adverse events

Adverse Events

Delgocitinib |20 mg/g

Serious events: 5 serious events

Other events: 70 other events

Deaths: 0 deaths

Vehicle|

Serious events: 3 serious events

Other events: 43 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Delgocitinib \|20 mg/g n=313 participants at risk Delgocitinib 20 mg/g (N=313)	Vehicle\| n=159 participants at risk Vehicle (N=159)
Cardiac disorders Cardiac tamponade	0.00% 0/313 • 16 weeks	0.63% 1/159 • Number of events 1 • 16 weeks
Infections and infestations COVID-19 pneumonia	0.32% 1/313 • Number of events 1 • 16 weeks	0.00% 0/159 • 16 weeks
Infections and infestations Peritonsillar abscess	0.32% 1/313 • Number of events 1 • 16 weeks	0.00% 0/159 • 16 weeks
Nervous system disorders Epilepsy	0.32% 1/313 • Number of events 1 • 16 weeks	0.00% 0/159 • 16 weeks
Nervous system disorders Migraine	0.32% 1/313 • Number of events 1 • 16 weeks	0.00% 0/159 • 16 weeks
Nervous system disorders Notalgia paraesthetica	0.00% 0/313 • 16 weeks	0.63% 1/159 • Number of events 1 • 16 weeks
Respiratory, thoracic and mediastinal disorders Pulmonary oedema	0.00% 0/313 • 16 weeks	0.63% 1/159 • Number of events 1 • 16 weeks
Skin and subcutaneous tissue disorders Hand dermatitis	0.32% 1/313 • Number of events 1 • 16 weeks	0.63% 1/159 • Number of events 1 • 16 weeks

Other adverse events

Other adverse events
Measure	Delgocitinib \|20 mg/g n=313 participants at risk Delgocitinib 20 mg/g (N=313)	Vehicle\| n=159 participants at risk Vehicle (N=159)
Infections and infestations COVID-19	11.5% 36/313 • Number of events 36 • 16 weeks	12.6% 20/159 • Number of events 20 • 16 weeks
Infections and infestations Herpes simplex	0.32% 1/313 • Number of events 1 • 16 weeks	2.5% 4/159 • Number of events 4 • 16 weeks
Infections and infestations Nasopharyngitis	6.7% 21/313 • Number of events 24 • 16 weeks	6.3% 10/159 • Number of events 10 • 16 weeks
Infections and infestations Pharyngitis	0.96% 3/313 • Number of events 3 • 16 weeks	3.1% 5/159 • Number of events 6 • 16 weeks
Nervous system disorders Headache	6.1% 19/313 • Number of events 25 • 16 weeks	5.7% 9/159 • Number of events 11 • 16 weeks
Skin and subcutaneous tissue disorders Hand dermatitis	0.64% 2/313 • Number of events 2 • 16 weeks	3.1% 5/159 • Number of events 5 • 16 weeks

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