Ignite Creation Date:
2025-12-25 @ 4:49 AM
Ignite Modification Date:
2025-12-26 @ 3:50 AM
Study NCT ID:
NCT05355818
Status:
COMPLETED
Last Update Posted:
2025-07-29
First Post:
2022-04-27
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'C000621572', 'term': 'delgocitinib'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'disclosure@leo-pharma.com', 'phone': '+45 4494 5888', 'title': 'Clinical Disclosure', 'organization': 'LEO Pharma A/S'}, 'certainAgreement': {'otherDetails': 'The sponsor seeks publication of all clinical trials in peer-reviewed journals within 12 months after completion or termination of the clinical trial, regardless of whether the findings are positive or negative. If no publication is submitted by the sponsor within these 12 months, the investigator has the right to publish the results from clinical trial generated by him/herself.', 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'Treatment emergent adverse events were collected during the 16 weeks of treatment + 2 weeks of follow-up.', 'eventGroups': [{'id': 'EG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.', 'otherNumAtRisk': 74, 'deathsNumAtRisk': 74, 'otherNumAffected': 17, 'seriousNumAtRisk': 74, 'deathsNumAffected': 0, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.', 'otherNumAtRisk': 24, 'deathsNumAtRisk': 24, 'otherNumAffected': 4, 'seriousNumAtRisk': 24, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 12, 'numAffected': 10}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 5, 'numAffected': 5}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}, {'term': 'Headache', 'stats': [{'groupId': 'EG000', 'numAtRisk': 74, 'numEvents': 4, 'numAffected': 4}, {'groupId': 'EG001', 'numAtRisk': 24, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA 24.0'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Number of Participants With IGA-CHE Treatment Success at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '47', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Diff. in proportion of responders in %', 'ciNumSides': 'TWO_SIDED', 'paramValue': '37.9', 'pValueComment': 'There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \\> 0 is used.', 'estimateComment': 'There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 13.5% to 58.2%.', 'groupDescription': "Based on the primary estimand 'composite'. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.", 'statisticalMethod': 'Bayesian', 'nonInferiorityType': 'SUPERIORITY', 'statisticalComment': 'Historical information from LP0133-1401 (NCT04871711)/LP0133-1402 (NCT04872101) as prior information is used.'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With HECSI-90 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '53', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Diff. in proportion of responders in %', 'ciNumSides': 'TWO_SIDED', 'paramValue': '36.4', 'pValueComment': 'There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \\> 0 is used.', 'estimateComment': 'There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 12.3% to 59.9%.', 'groupDescription': 'Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.', 'statisticalMethod': 'Bayesian', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': '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.', 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '35', 'groupId': 'OG000'}, {'value': '7', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Diff. in proportion of responders in %', 'ciNumSides': 'TWO_SIDED', 'paramValue': '31.7', 'pValueComment': 'There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \\> 0 is used.', 'estimateComment': 'There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 5.6% to 51.1%.', 'statisticalMethod': 'Bayesian', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available for 20 participants in the Delgocitinib cream group and for 5 participants in the cream vehicle group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '15', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '31', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Diff. in proportion of responders in %', 'ciNumSides': 'TWO_SIDED', 'paramValue': '31.2', 'pValueComment': 'There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \\> 0 is used.', 'estimateComment': 'There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 8.7% to 49.4%', 'statisticalMethod': 'Bayesian', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available for 25 participants in the Delgocitinib cream group and for 9 participants in the cream vehicle group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '54', 'groupId': 'OG000'}, {'value': '16', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '30', 'groupId': 'OG000'}, {'value': '5', 'groupId': 'OG001'}]}]}], 'analyses': [{'groupIds': ['OG000', 'OG001'], 'paramType': 'Diff. in proportion of responders in %', 'ciNumSides': 'TWO_SIDED', 'paramValue': '25.1', 'pValueComment': 'There are no p-values when performing a Bayesian analysis. Instead, the probability that the difference in the posterior distributions is \\> 0 is used.', 'estimateComment': 'There is no confidence interval when performing Bayesian analyses - instead a 95% credibility interval is used: 3.9% to 42.3%.', 'groupDescription': 'Primary estimand: Composite. Data considered non-response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed as non-response.', 'statisticalMethod': 'Bayesian', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': 'Data is not available for 20 participants in the Delgocitinib cream group and for 8 participants in the cream vehicle group.'}, {'type': 'SECONDARY', 'title': 'Number of Participants With IGA-CHE Treatment Success at Week 2', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '16', 'groupId': 'OG000'}, {'value': '1', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0054', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '17.47', 'ciLowerLimit': '5.16', 'ciUpperLimit': '29.78', 'estimateComment': 'Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.', 'groupDescription': 'The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 2', 'description': "The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With IGA-CHE Treatment Success at Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '28', 'groupId': 'OG000'}, {'value': '4', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0248', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '21.21', 'ciLowerLimit': '2.69', 'ciUpperLimit': '39.72', 'estimateComment': 'Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.', 'groupDescription': 'The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 4', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With IGA-CHE Treatment Success at Week 8', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '36', 'groupId': 'OG000'}, {'value': '9', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.3320', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '11.08', 'ciLowerLimit': '-11.30', 'ciUpperLimit': '33.46', 'estimateComment': 'Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.', 'groupDescription': 'The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 8', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Participants With IGA-CHE Treatment Success at Week 12', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '43', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0016', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Risk Difference (RD)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '33.02', 'ciLowerLimit': '12.51', 'ciUpperLimit': '53.52', 'estimateComment': 'Risk difference estimated using logistic regression stratified by baseline IGA-CHE score.', 'groupDescription': 'The primary estimand using the composite strategy is used for the analysis. Data is considered non response after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data is imputed as non-response.', 'statisticalMethod': 'Regression, Logistic', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'timeFrame': 'Week 12', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline.", 'calculatePct': False, 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Change in CDLQI Score From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '-5.57', 'spread': '0.44', 'groupId': 'OG000'}, {'value': '-2.92', 'spread': '0.78', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.0038', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Net)', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '-2.65', 'ciLowerLimit': '-4.42', 'ciUpperLimit': '-0.88', 'groupDescription': 'Primary estimand: Composite. Data considered non-response by using WOCF (including the baseline value) after initiation of rescue treatment or after permanent discontinuation of IMP. Missing data imputed using WOCF (including the baseline value).', 'statisticalMethod': 'ANCOVA', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Week 16', 'description': "The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI 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.", 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Number of Treatment Emergent AEs From Baseline up to Week 18', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'OG000'}, {'value': '24', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'OG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'classes': [{'categories': [{'measurements': [{'value': '77', 'groupId': 'OG000'}, {'value': '19', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Week 18', 'description': 'An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.', 'unitOfMeasure': 'events', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'FG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '74'}, {'groupId': 'FG001', 'numSubjects': '24'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '71'}, {'groupId': 'FG001', 'numSubjects': '21'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '3'}]}], 'dropWithdraws': [{'type': 'Adverse Event', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '2'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '0'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'This trial was conducted at sites in 7 countries (Australia, Belgium, Canada, Spain, France, United Kingdom, and Poland).', 'preAssignmentDetails': 'Participants were randomized 3:1 to treatment with delgocitinib cream 20 mg/g or cream vehicle.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Delgocitinib Cream', 'description': 'Participants were randomized to twice-daily topical applications of delgocitinib cream 20 mg/g for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nDelgocitinib cream: Cream for topical application.'}, {'id': 'BG001', 'title': 'Cream Vehicle', 'description': 'Participants were randomized to twice-daily applications of cream vehicle for a 16-week treatment period followed by a follow-up period of 2 weeks for assessment of safety.\n\nCream vehicle: The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': '<=18 years', 'measurements': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '14.6', 'spread': '1.7', 'groupId': 'BG000'}, {'value': '14.7', 'spread': '1.6', 'groupId': 'BG001'}, {'value': '14.6', 'spread': '1.7', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '46', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '58', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '12', 'groupId': 'BG001'}, {'value': '40', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '8', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '62', 'groupId': 'BG000'}, {'value': '21', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Race (NIH/OMB)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': 'American Indian or Alaska Native', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Asian', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '3', 'groupId': 'BG002'}]}, {'title': 'Native Hawaiian or Other Pacific Islander', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Black or African American', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}, {'title': 'White', 'measurements': [{'value': '69', 'groupId': 'BG000'}, {'value': '20', 'groupId': 'BG001'}, {'value': '89', 'groupId': 'BG002'}]}, {'title': 'More than one race', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'Region of Enrollment', 'classes': [{'title': 'Canada', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '6', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Belgium', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}, {'title': 'Poland', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '23', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '32', 'groupId': 'BG002'}]}]}, {'title': 'United Kingdom', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5', 'groupId': 'BG000'}, {'value': '2', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Australia', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '10', 'groupId': 'BG000'}, {'value': '4', 'groupId': 'BG001'}, {'value': '14', 'groupId': 'BG002'}]}]}, {'title': 'France', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '11', 'groupId': 'BG000'}, {'value': '5', 'groupId': 'BG001'}, {'value': '16', 'groupId': 'BG002'}]}]}, {'title': 'Spain', 'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '20', 'groupId': 'BG002'}]}]}], 'paramType': 'NUMBER', 'unitOfMeasure': 'participants'}, {'title': 'IGA-CHE score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'title': 'Clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Almost clear', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Mild', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Moderate', 'measurements': [{'value': '56', 'groupId': 'BG000'}, {'value': '18', 'groupId': 'BG001'}, {'value': '74', 'groupId': 'BG002'}]}, {'title': 'Severe', 'measurements': [{'value': '18', 'groupId': 'BG000'}, {'value': '6', 'groupId': 'BG001'}, {'value': '24', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'description': "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).", 'calculatePct': False, 'unitOfMeasure': 'Participants'}, {'title': 'HECSI score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '70.9', 'spread': '37.8', 'groupId': 'BG000'}, {'value': '76.2', 'spread': '39.7', 'groupId': 'BG001'}, {'value': '72.2', 'spread': '38.1', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': '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.', 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'HESD itch score (weekly average)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.56', 'spread': '2.59', 'groupId': 'BG000'}, {'value': '5.91', 'spread': '3.01', 'groupId': 'BG001'}, {'value': '5.65', 'spread': '2.69', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Hand Eczema Symptom Diary (HESD) itch score is one component of the HESD eDiary. In the HESD eDiary, 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.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is missing for 1 participant in the delgocitinib cream group.'}, {'title': 'HESD pain score (weekly average)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.20', 'spread': '2.75', 'groupId': 'BG000'}, {'value': '5.65', 'spread': '3.49', 'groupId': 'BG001'}, {'value': '5.31', 'spread': '2.94', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Hand Eczema Symptom Diary (HESD) pain score is one component of the HESD eDiary. In the HESD eDiary, 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.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is missing for 1 participant in the delgocitinib cream group.'}, {'title': 'HESD score (weekly average)', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '73', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '97', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '5.63', 'spread': '2.26', 'groupId': 'BG000'}, {'value': '5.75', 'spread': '3.00', 'groupId': 'BG001'}, {'value': '5.66', 'spread': '2.45', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "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.", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION', 'populationDescription': 'Data is missing for 1 participant in the delgocitinib cream group.'}, {'title': 'CDLQI score', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '74', 'groupId': 'BG000'}, {'value': '24', 'groupId': 'BG001'}, {'value': '98', 'groupId': 'BG002'}]}], 'categories': [{'measurements': [{'value': '8.5', 'spread': '5.5', 'groupId': 'BG000'}, {'value': '9.6', 'spread': '6.8', 'groupId': 'BG001'}, {'value': '8.8', 'spread': '5.8', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'description': "The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI score is the sum of the 10 items (score ranging from 0 to 30).", 'unitOfMeasure': 'scores on a scale', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2023-12-11', 'size': 8117871, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2025-05-05T05:24', 'hasProtocol': True}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 98}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2024-12-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2022-04-27', 'resultsFirstSubmitDate': '2025-06-17', 'studyFirstSubmitQcDate': '2022-04-27', 'lastUpdatePostDateStruct': {'date': '2025-07-29', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2025-06-17', 'studyFirstPostDateStruct': {'date': '2022-05-02', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-07-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Number of Participants With IGA-CHE Treatment Success at Week 16', 'timeFrame': 'Week 16', 'description': "The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline."}], 'secondaryOutcomes': [{'measure': 'Number of Participants With HECSI-90 at Week 16', 'timeFrame': 'Week 16', 'description': '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.'}, {'measure': 'Number of Participants With Reduction of HESD Itch Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'itch' component for participants with a baseline HESD itch score (weekly average) of ≥4 points."}, {'measure': 'Number of Participants With Reduction of HESD Pain Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' This endpoint will only assess the 'pain' component for participants with a baseline HESD pain score (weekly average) of ≥4 points."}, {'measure': 'Number of Participants With Reduction of HESD Score (Weekly Average) of ≥4 Points From Baseline at Week 16', 'timeFrame': 'Week 16', 'description': "The Hand Eczema Symptom Diary© (HESD) is an instrument designed to assess severity of CHE signs and symptoms. The participants will assess the worst severity of 6 individual signs and symptoms of CHE from 0 (none) to 10 (severe) over the past 24 hours. The participants will complete the HESD on a daily basis in an eDiary.' The final HESD score is an average of these 6 individual scores. This endpoint will only assess the score for participants with a baseline HESD itch score (weekly average) of ≥4 points."}, {'measure': 'Number of Participants With IGA-CHE Treatment Success at Week 2', 'timeFrame': 'Week 2', 'description': "The Investigator's Global Assessment for chronic hand eczema (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline."}, {'measure': 'Number of Participants With IGA-CHE Treatment Success at Week 4', 'timeFrame': 'Week 4', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline."}, {'measure': 'Number of Participants With IGA-CHE Treatment Success at Week 8', 'timeFrame': 'Week 8', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline."}, {'measure': 'Number of Participants With IGA-CHE Treatment Success at Week 12', 'timeFrame': 'Week 12', 'description': "The Investigator's Global Assessment for chronic hand eczema© (IGA-CHE) is a 5 point scale used in clinical trials to rate the severity of the subject's CHE from 0 (clear) to 4 (severe). Treatment success means a score of 0 (clear) or 1 (almost clear) with a ≥2 step improvement from baseline."}, {'measure': 'Change in CDLQI Score From Baseline to Week 16', 'timeFrame': 'Week 16', 'description': "The Children's Dermatology Life Quality Index (CDLQI) 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. Each question is scored from 0 (no impact) to 3 (high impact). The CDLQI 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."}, {'measure': 'Number of Treatment Emergent AEs From Baseline up to Week 18', 'timeFrame': 'Week 18', 'description': 'An adverse event (AE) will be considered treatment emergent if started after the first application of treatment, or started before the first application of treatment and worsened in severity after treatment.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Chronic Hand Eczema']}, 'descriptionModule': {'briefSummary': 'The purpose of this trial is to test if delgocitinib cream is effective in treating chronic hand eczema (CHE) and to find out what side effects it may have compared with a cream vehicle with no active medical ingredient in adolescents aged 12-17 years. At each visit to the clinic, the doctor will assess the severity and extent of CHE, and during the trial, the adolescents will assess their CHE signs and symptoms as well as quality of life.\n\nThe trial will last up to 22 weeks and has a 1-4 week screening period, a 16-week treatment period and a 2- week follow-up period. During the treatment period, each adolescent participant will use either the delgocitinib cream or cream vehicle twice daily.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Age 12 to 17 years at screening and baseline.\n* 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.\n* Disease severity graded as moderate to severe at screening and baseline according to IGA CHE (i.e. an IGA-CHE score of 3 or 4).\n* Subjects who have a documented recent history of inadequate response to treatment with topical corticosteroids (TCS) (at any time within 1 year before the screening visit) or for whom TCS are documented to be otherwise medically inadvisable (e.g. due to important side effects or safety risks).\n\n * Inadequate response is defined as a history of failure to achieve and maintain a low disease activity state (comparable to an IGA-CHE score of ≤2) despite treatment with a daily regimen of TCS of class III-IV (potent to very potent) for Europe and Australia and class IV-I (medium potency to very/ultra-high potency) for Canada, applied for at least 28 days or for the maximum duration recommended by the product prescribing information, whichever is shorter.\n * Important side effects or safety risks are those that outweigh the potential treatment benefits and include intolerance to treatment, hypersensitivity reactions, and significant skin atrophy as assessed by the physician.\n\nExclusion Criteria:\n\n* Concurrent skin diseases on the hands, e.g. tinea manuum.\n* Clinically significant infection (e.g. impetiginised hand eczema) on the hands.\n* Systemic treatment with immunosuppressive drugs (e.g. methotrexate, cyclosporine, azathioprine), immunomodulating drugs, retinoids (e.g. alitretinoin), or corticosteroids within 28 days prior to baseline (steroid eyedrops and inhaled or intranasal steroids corresponding to up to 1 mg prednisolone for allergic conjunctivitis, asthma, or rhinitis are allowed).\n* Use of tanning beds, phototherapy (e.g. ultraviolet B (UVB), ultraviolet A1 (UVA1), psoralen ultraviolet A (PUVA)), or bleach baths on the hands within 28 days prior to baseline.\n* Previous or current treatment with JAK inhibitors (including delgocitinib/LEO 124249), systemic or topical.\n* Cutaneously applied treatment with immunomodulators (e.g. PDE-4 inhibitors, pimecrolimus, tacrolimus) or TCS on the hands within 14 days prior to baseline.\n* Use of systemic antibiotics or cutaneously applied antibiotics on the hands within 14 days prior to baseline.\n* Other cutaneously applied therapy on the hands (except for the use of subject's own emollients) within 7 days prior to baseline.\n* 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.\n* Any disorder which is not stable and could:\n\n * Affect the safety of the subject throughout the trial.\n * Impede the subject's ability to complete the trial. Examples include but are not limited to cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, immunological, and psychiatric disorders, and major physical impairment."}, 'identificationModule': {'nctId': 'NCT05355818', 'acronym': 'DELTA TEEN', 'briefTitle': 'Efficacy and Safety of Delgocitinib Cream in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema', 'organization': {'class': 'INDUSTRY', 'fullName': 'LEO Pharma'}, 'officialTitle': 'A Phase 3 Clinical Trial to Evaluate Efficacy and Safety of Twice-daily Applications of Delgocitinib Cream 20 mg/g Compared With Cream Vehicle for a 16-week Treatment Period in Adolescents 12-17 Years of Age With Moderate to Severe Chronic Hand Eczema (DELTA TEEN)', 'orgStudyIdInfo': {'id': 'LP0133-1426'}, 'secondaryIdInfos': [{'id': '2021-006340-27', 'type': 'EUDRACT_NUMBER'}, {'id': 'U1111-1284-2122', 'type': 'OTHER', 'domain': 'World Health Organization (WHO)'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Delgocitinib cream', 'description': 'Delgocitinib cream 20 mg/g twice daily', 'interventionNames': ['Drug: Delgocitinib']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Cream vehicle', 'description': 'Cream vehicle twice daily', 'interventionNames': ['Drug: Cream vehicle']}], 'interventions': [{'name': 'Delgocitinib', 'type': 'DRUG', 'description': 'Cream for topical application', 'armGroupLabels': ['Delgocitinib cream']}, {'name': 'Cream vehicle', 'type': 'DRUG', 'description': 'The cream vehicle is similar to the delgocitinib cream except that it does not contain any active medical ingredient.', 'armGroupLabels': ['Cream vehicle']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2010', 'city': 'Darlinghurst', 'country': 'Australia', 'facility': 'LEO Pharma investigational site', 'geoPoint': {'lat': -33.87939, 'lon': 151.21925}}, {'zip': '3132', 'city': 'Mitcham', 'country': 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