| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
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| 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. | Cochran-Mantel-Haenszel | Stratified by region and baseline IGA-CHE score. | 0.006 | 5% significance level (two-sided). | Risk Difference (RD) | 9.8 | | | 2-Sided | 95 | 3.6 | 16.1 | | | Mantel-Haenszel risk difference, stratified by region and baseline IGA-CHE score. | | Superiority |
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| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 2 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 4 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Count of Participants | | Participants | | 8 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | percentage change | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| Secondary | Change in HEIS PDAL Score From Baseline to Week 16 | Proximal Daily Activity Limitations (PDAL) is one of the domain scores in Hand Eczema Impact Scale (HEIS) assessing the participant's perceived impact on their daily activities. Each item is scored on a 5-point scale ranging from 0 (not at all) to 4 (extremely). HEIS PDAL score is the average of the 3 items. | | Posted | | Least Squares Mean | Standard Error | score on a scale | | 16 weeks | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| Secondary | 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. | | Posted | | Count of Participants | | Participants | | 16 weeks | | | | ID | Title | Description |
|---|
| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks> > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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| 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. | | Posted | | Number | | Adverse events | | 16 weeks (18 weeks for participants not participating in the long-term extension trial [LP0133-1403]) | | | | ID | Title | Description |
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| OG000 | Delgocitinib Cream 20 mg/g | Twice-daily topical application for 16 weeks > > Delgocitinib cream: Cream for topical application | | OG001 | 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. |
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