Chronic Hand Eczema
Conditions
Brief 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.
Interventions
Cream for topical application
DRUGCream vehicle
The cream vehicle is similar to the delgocitinib cream except that it does not contain any active ingredient.
Sponsors
LEO Pharma
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With IGA-CHE TS at Week 16 | 16 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 chronic hand eczema (CHE) and is based on a 5-point scale ranging from 0 (clear) to 4 (severe). IGA-CHE treatment success (IGA-CHE TS) is defined as an IGA-CHE score of 0 (clear) or 1 (almost clear) with a ≥2-step improvement from baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With IGA-CHE TS at Week 4 | 4 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. |
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 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. |
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 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. |
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 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 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 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 'itch' component and will be evaluated among participants with a baseline HESD itch score (weekly average) ≥4 points. |
| Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2 | 2 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. |
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 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. |
| Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 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. |
| Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 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. |
| Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 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. |
| Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 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. |
| Number of Participants With IGA-CHE TS at Week 8 | 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. |
| Number of Participants With HECSI-75 at Week 16 | 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. |
| Number of Participants With HECSI-75 at Week 8 | 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. |
| Percentage Change in HECSI Score From Baseline to Week 16 | 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. |
| Change in DLQI Score From Baseline to Week 16 | 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. |
| Change in HESD Score (Weekly Average) From Baseline to Week 16 | 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. |
| Change in HESD Itch Score (Weekly Average) From Baseline to Week 16 | 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. |
| Change in HESD Pain Score (Weekly Average) From Baseline to Week 16 | 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. |
| Change in HEIS Score From Baseline to Week 16 | 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. |
| Change in HEIS PDAL Score From Baseline to Week 16 | 16 weeks | 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). |
| Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16 | 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. This endpoint will be evaluated among participants with a baseline DLQI score ≥4 points. |
| Number of Treatment-emergent AEs From Baseline up to End of Trial | 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. |
| Number of Participants With HECSI-90 at Week 16 | 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. |
Countries
Belgium, Canada, Denmark, Germany, Netherlands, Poland, Spain
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Delgocitinib Cream 20 mg/g Twice-daily topical application for 16 weeks\>
\> Delgocitinib cream: Cream for topical application | 314 |
| 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. | 159 |
| Total | 473 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Overall Study | Adverse Event | 1 | 6 |
| Overall Study | Lack of Efficacy | 6 | 14 |
| Overall Study | Lost to Follow-up | 2 | 1 |
| Overall Study | Not dosed | 1 | 0 |
| Overall Study | Pregnancy | 2 | 0 |
| Overall Study | Prohibited Medication | 1 | 0 |
| Overall Study | Withdrawal by Subject | 10 | 16 |
Baseline characteristics
| Characteristic | Cream Vehicle | Delgocitinib Cream 20 mg/g | Total |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 9 Participants | 28 Participants | 37 Participants |
| Age, Categorical Between 18 and 65 years | 150 Participants | 286 Participants | 436 Participants |
| Age, Continuous | 42.6 years STANDARD_DEVIATION 14.3 | 45.3 years STANDARD_DEVIATION 14.6 | 44.4 years STANDARD_DEVIATION 14.5 |
| Baseline DLQI score | 12.2 units on a scale STANDARD_DEVIATION 6.6 | 12.1 units on a scale STANDARD_DEVIATION 6.2 | 12.1 units on a scale STANDARD_DEVIATION 6.3 |
| Baseline HECSI score | 67.7 units on a scale STANDARD_DEVIATION 39.5 | 64.3 units on a scale STANDARD_DEVIATION 37.9 | 65.5 units on a scale STANDARD_DEVIATION 38.5 |
| Baseline HEIS PDAL score | 2.56 units on a scale STANDARD_DEVIATION 0.94 | 2.54 units on a scale STANDARD_DEVIATION 0.9 | 2.55 units on a scale STANDARD_DEVIATION 0.91 |
| Baseline HEIS score | 2.46 units on a scale STANDARD_DEVIATION 0.84 | 2.42 units on a scale STANDARD_DEVIATION 0.79 | 2.43 units on a scale STANDARD_DEVIATION 0.8 |
| Baseline HESD itch score (weekly average) | 6.98 units on a scale STANDARD_DEVIATION 1.51 | 6.99 units on a scale STANDARD_DEVIATION 1.55 | 6.99 units on a scale STANDARD_DEVIATION 1.53 |
| Baseline HESD pain score (weekly average) | 6.46 units on a scale STANDARD_DEVIATION 1.96 | 6.62 units on a scale STANDARD_DEVIATION 1.81 | 6.56 units on a scale STANDARD_DEVIATION 1.86 |
| Baseline HESD score (weekly average) | 6.91 units on a scale STANDARD_DEVIATION 1.51 | 6.97 units on a scale STANDARD_DEVIATION 1.46 | 6.95 units on a scale STANDARD_DEVIATION 1.47 |
| Baseline IGA-CHE score 0 - Clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA-CHE score 1 - Almost clear | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA-CHE score 2 - Mild | 0 Participants | 0 Participants | 0 Participants |
| Baseline IGA-CHE score 3 - Moderate | 121 Participants | 239 Participants | 360 Participants |
| Baseline IGA-CHE score 4 - Severe | 38 Participants | 75 Participants | 113 Participants |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 2 Participants | 7 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 152 Participants | 310 Participants | 462 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 2 Participants | 2 Participants | 4 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 8 Participants | 15 Participants |
| Race (NIH/OMB) Black or African American | 1 Participants | 2 Participants | 3 Participants |
| Race (NIH/OMB) More than one race | 3 Participants | 1 Participants | 4 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 1 Participants | 1 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 2 Participants | 7 Participants | 9 Participants |
| Race (NIH/OMB) White | 146 Participants | 295 Participants | 441 Participants |
| Region of Enrollment Belgium | 11 participants | 11 participants | 22 participants |
| Region of Enrollment Canada | 33 participants | 64 participants | 97 participants |
| Region of Enrollment Denmark | 3 participants | 19 participants | 22 participants |
| Region of Enrollment Germany | 49 participants | 98 participants | 147 participants |
| Region of Enrollment Netherlands | 11 participants | 13 participants | 24 participants |
| Region of Enrollment Poland | 32 participants | 64 participants | 96 participants |
| Region of Enrollment Spain | 20 participants | 45 participants | 65 participants |
| Sex: Female, Male Female | 108 Participants | 204 Participants | 312 Participants |
| Sex: Female, Male Male | 51 Participants | 110 Participants | 161 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 313 | 0 / 159 |
| other Total, other adverse events | 70 / 313 | 43 / 159 |
| serious Total, serious adverse events | 5 / 313 | 3 / 159 |
Outcome results
Primary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With IGA-CHE TS at Week 16 | 91 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE TS at Week 16 | 11 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [15.8, 28.5]Cochran-Mantel-Haenszel
Secondary
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
Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in DLQI Score From Baseline to Week 16 | -7.0 score on a scale | Standard Error 0.3 |
| Cream Vehicle | Change in DLQI Score From Baseline to Week 16 | -3.1 score on a scale | Standard Error 0.5 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-5, -2.8]ANCOVA
Secondary
Change in HEIS PDAL Score From Baseline to Week 16
Proximal Daily Activity Limitations (PDAL) is one of the items addressed in the Hand Eczema Impact Scale (HEIS) and is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely).
Time frame: 16 weeks
Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in HEIS PDAL Score From Baseline to Week 16 | -1.48 score on a scale | Standard Error 0.06 |
| Cream Vehicle | Change in HEIS PDAL Score From Baseline to Week 16 | -0.66 score on a scale | Standard Error 0.08 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-1.01, -0.62]ANCOVA
Secondary
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
Population: Data is not available for 4 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in HEIS Score From Baseline to Week 16 | -1.45 score on a scale | Standard Error 0.06 |
| Cream Vehicle | Change in HEIS Score From Baseline to Week 16 | -0.64 score on a scale | Standard Error 0.08 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-0.99, -0.62]ANCOVA
Secondary
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
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in HESD Itch Score (Weekly Average) From Baseline to Week 16 | -3.4 score on a scale | Standard Error 0.2 |
| Cream Vehicle | Change in HESD Itch Score (Weekly Average) From Baseline to Week 16 | -1.4 score on a scale | Standard Error 0.2 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-2.5, -1.4]ANCOVA
Secondary
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
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in HESD Pain Score (Weekly Average) From Baseline to Week 16 | -3.3 score on a scale | Standard Error 0.2 |
| Cream Vehicle | Change in HESD Pain Score (Weekly Average) From Baseline to Week 16 | -1.3 score on a scale | Standard Error 0.2 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-2.6, -1.5]ANCOVA
Secondary
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
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.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Change in HESD Score (Weekly Average) From Baseline to Week 16 | -3.2 score on a scale | Standard Error 0.1 |
| Cream Vehicle | Change in HESD Score (Weekly Average) From Baseline to Week 16 | -1.4 score on a scale | Standard Error 0.2 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-2.4, -1.4]ANCOVA
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With HECSI-75 at Week 16 | 155 Participants |
| Cream Vehicle | Number of Participants With HECSI-75 at Week 16 | 29 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [23.1, 39.5]Cochran-Mantel-Haenszel
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With HECSI-75 at Week 8 | 158 Participants |
| Cream Vehicle | Number of Participants With HECSI-75 at Week 8 | 31 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [22.7, 39.3]Cochran-Mantel-Haenszel
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With HECSI-90 at Week 16 | 97 Participants |
| Cream Vehicle | Number of Participants With HECSI-90 at Week 16 | 14 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [15.4, 29]Cochran-Mantel-Haenszel
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With IGA-CHE TS at Week 4 | 46 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE TS at Week 4 | 13 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: 0.04395% CI: [0.8, 12.3]Cochran-Mantel-Haenszel
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With IGA-CHE TS at Week 8 | 101 Participants |
| Cream Vehicle | Number of Participants With IGA-CHE TS at Week 8 | 15 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [16, 29.8]Cochran-Mantel-Haenszel
Secondary
Number of Participants With 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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16 | 216 Participants |
| Cream Vehicle | Number of Participants With Reduction of DLQI Score of ≥4 Points From Baseline at Week 16 | 70 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [17, 35.9]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 146 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 31 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [19, 35.8]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2 | 40 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 2 | 10 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: 0.03195% CI: [1.1, 12]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 94 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 19 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [11, 25.6]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 131 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 21 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [21.3, 36.7]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 143 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 32 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [17, 35.1]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 91 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 15 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [13.1, 27.8]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 124 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 18 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [21.7, 37.4]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 137 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16 | 32 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [15.1, 32.2]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 80 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 4 | 14 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [10.2, 23.7]Cochran-Mantel-Haenszel
Secondary
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
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.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 115 Participants |
| Cream Vehicle | Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 8 | 19 Participants |
Comparison: Based on the primary analysis of the primary estimand 'composite'. Subjects with missing data, subjects who received rescue treatment, or subjects who permanently discontinued IMP were considered non-responders.p-value: <0.00195% CI: [17.5, 32.5]Cochran-Mantel-Haenszel
Secondary
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])
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Delgocitinib Cream 20 mg/g | Number of Treatment-emergent AEs From Baseline up to End of Trial | 269 Adverse events |
| Cream Vehicle | Number of Treatment-emergent AEs From Baseline up to End of Trial | 145 Adverse events |
Secondary
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
Population: Data is not available for 1 participant in the Delgocitinib cream 20 mg/g group.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| Delgocitinib Cream 20 mg/g | Percentage Change in HECSI Score From Baseline to Week 16 | -58.9 percentage change | Standard Error 3.2 |
| Cream Vehicle | Percentage Change in HECSI Score From Baseline to Week 16 | -13.4 percentage change | Standard Error 4.5 |
Comparison: Primary analysis of primary estimand 'composite'. Missing data for subjects who did not attend the visit was imputed as WOCF (including baseline value). For subjects who received rescue treatment or subjects who have permanently discontinued the IMP, observed data was considered non-response by using WOCF (including baseline value).p-value: <0.00195% CI: [-56.4, -34.6]ANCOVA