Ignite Creation Date:
2025-12-25 @ 2:00 AM
Ignite Modification Date:
2025-12-26 @ 1:29 AM
Study NCT ID:
NCT04417894
Status:
COMPLETED
Last Update Posted:
2023-12-22
First Post:
2020-06-02
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'firstMcpInfo': {'postDateStruct': {'date': '2023-09-26', 'type': 'ACTUAL'}}}}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'clinicaltrials@regeneron.com', 'phone': '844-734-6643', 'title': 'Clinical Trials Administrator', 'organization': 'Regeneron Pharmaceuticals, Inc.'}, 'certainAgreement': {'otherDetails': "The investigator has the right to independently publish study results from the investigator's site after a multi-center publication, or a defined period after the completion of the study by all sites. The investigator must provide the sponsor a copy of any such publication derived from the study for review and comment in advance of any submission, and delay publication, if requested, to allow the Sponsor to preserve its proprietary rights.", 'restrictionType': 'OTHER', 'piSponsorEmployee': False, 'restrictiveAgreement': True}}, 'adverseEventsModule': {'timeFrame': 'From first dose to Week 28', 'description': 'Participants included adults and adolescents (≥12 years) and were randomized at 1:1 to Dupilumab and placebo. For each group, adults and adolescents with body weight ≥60kg who had 300mg Q2W is similar to adolescents with body weight \\< 60kg who had 200mg Q2W. The 300mg Q2W and 200mg Q2W were similar dosing for participants with different weight and age, rather than different dosing for the same population. Thus, they were combined to compare Dupilumab with placebo.', 'eventGroups': [{'id': 'EG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1', 'otherNumAtRisk': 66, 'deathsNumAtRisk': 66, 'otherNumAffected': 34, 'seriousNumAtRisk': 66, 'deathsNumAffected': 0, 'seriousNumAffected': 1}, {'id': 'EG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1', 'otherNumAtRisk': 67, 'deathsNumAtRisk': 67, 'otherNumAffected': 33, 'seriousNumAtRisk': 67, 'deathsNumAffected': 0, 'seriousNumAffected': 3}], 'otherEvents': [{'term': 'COVID-19', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 14, 'numAffected': 14}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 11, 'numAffected': 11}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Nasopharyngitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 13, 'numAffected': 8}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 18, 'numAffected': 16}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Upper respiratory tract infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 3, 'numAffected': 3}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 9, 'numAffected': 7}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dermatitis atopic', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 18, 'numAffected': 16}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 6, 'numAffected': 6}], 'organSystem': 'Skin and subcutaneous tissue disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Blood creatine phosphokinase increased', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Investigations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'seriousEvents': [{'term': 'Appendicitis', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 1, 'numAffected': 1}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 0, 'numAffected': 0}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Post procedural infection', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Infections and infestations', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Adenocarcinoma of colon', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Metastases to lung', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Neoplasms benign, malignant and unspecified (incl cysts and polyps)', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Dizziness', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}, {'term': 'Syncope', 'stats': [{'groupId': 'EG000', 'numAtRisk': 66, 'numEvents': 0, 'numAffected': 0}, {'groupId': 'EG001', 'numAtRisk': 67, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Nervous system disorders', 'assessmentType': 'SYSTEMATIC_ASSESSMENT', 'sourceVocabulary': 'MedDRA (25.1)'}], 'frequencyThreshold': '5'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '40.3', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '=0.0030', 'groupIds': ['OG000', 'OG001'], 'statisticalMethod': 'Cochran-Mantel-Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'At week 16', 'description': 'IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '13.6', 'groupId': 'OG000'}, {'value': '52.2', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '<0.0001', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Difference', 'ciNumSides': 'TWO_SIDED', 'ciPctValue': '95', 'paramValue': '38.6', 'ciLowerLimit': '24.06', 'ciUpperLimit': '53.15', 'statisticalMethod': 'Mantel Haenszel', 'nonInferiorityType': 'SUPERIORITY'}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '16.7', 'groupId': 'OG000'}, {'value': '61.2', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-26.2', 'groupId': 'OG000', 'lowerLimit': '-38.0', 'upperLimit': '-14.4'}, {'value': '-62.9', 'groupId': 'OG001', 'lowerLimit': '-74.6', 'upperLimit': '-51.3'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).", 'unitOfMeasure': 'Percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-31.0', 'groupId': 'OG000', 'lowerLimit': '-42.6', 'upperLimit': '-19.4'}, {'value': '-69.4', 'groupId': 'OG001', 'lowerLimit': '-80.9', 'upperLimit': '-58.0'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to Week 16', 'description': 'mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).', 'unitOfMeasure': 'Percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': 'The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized).'}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-1.93', 'spread': '0.432', 'groupId': 'OG000'}, {'value': '-4.66', 'spread': '0.426', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 16', 'description': "Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible).", 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-0.00', 'spread': '0.335', 'groupId': 'OG000'}, {'value': '0.88', 'spread': '0.334', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-10.01', 'spread': '2.388', 'groupId': 'OG000'}, {'value': '-16.70', 'spread': '2.375', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 16', 'unitOfMeasure': 'Percentage of hand and foot BSA', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-25.6', 'groupId': 'OG000', 'lowerLimit': '-36.3', 'upperLimit': '-15.0'}, {'value': '-47.2', 'groupId': 'OG001', 'lowerLimit': '-57.7', 'upperLimit': '-36.6'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 4', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).", 'unitOfMeasure': 'Percentage of change', 'dispersionType': '95% Confidence Interval', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '9.1', 'groupId': 'OG000'}, {'value': '34.3', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Baseline to week 4', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable).", 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "The full analysis set (FAS) includes all randomized participants. Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-33.8', 'spread': '42.21', 'groupId': 'OG000'}, {'value': '-68.2', 'spread': '25.56', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).', 'unitOfMeasure': 'Percentage of change', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HECSI-75 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '21.5', 'groupId': 'OG000'}, {'value': '46.9', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 16', 'description': 'HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HECSI-50 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '30.8', 'groupId': 'OG000'}, {'value': '75.0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 16', 'description': 'HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With HECSI-90 at Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '9.2', 'groupId': 'OG000'}, {'value': '18.8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'At week 16', 'description': 'HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analyses was based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '65', 'groupId': 'OG000'}, {'value': '64', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-13.36', 'spread': '21.222', 'groupId': 'OG000'}, {'value': '-38.70', 'spread': '23.920', 'groupId': 'OG001'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "Efficacy analyses will be based on the treatment allocated at randomization (as randomized). Here 'n' = number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '-21.26', 'spread': '3.761', 'groupId': 'OG000'}, {'value': '-36.39', 'spread': '3.649', 'groupId': 'OG001'}]}]}], 'paramType': 'LEAST_SQUARES_MEAN', 'timeFrame': 'Baseline to week 16', 'description': 'WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.', 'unitOfMeasure': 'Score on a scale', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'OG000'}, {'value': '67', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'classes': [{'categories': [{'measurements': [{'value': '74.2', 'groupId': 'OG000'}, {'value': '65.7', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Through week 16', 'unitOfMeasure': 'Percentage of participants', 'reportingStatus': 'POSTED', 'populationDescription': 'The safety analysis set (SAF) includes all randomized patients who receive at least one dose of study drug and will be analyzed as treated.'}, {'type': 'SECONDARY', 'title': 'Trough Concentration of Functional Dupilumab in Serum at Various Time Points', 'denoms': [{'units': 'Participants', 'counts': [{'value': '49', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'groups': [{'id': 'OG000', 'title': 'Dupilumab 300 mg - Adult Participants', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab 200 mg - Adolescent Participants', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG002', 'title': 'Dupilumab 300 mg - Adolescent Participants', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}], 'classes': [{'title': 'Week 0', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '6', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '0', 'spread': '0', 'groupId': 'OG000'}, {'value': '0', 'spread': '0', 'groupId': 'OG001'}, {'value': '0', 'spread': '0', 'groupId': 'OG002'}]}]}, {'title': 'Week 16', 'denoms': [{'units': 'Participants', 'counts': [{'value': '48', 'groupId': 'OG000'}, {'value': '6', 'groupId': 'OG001'}, {'value': '4', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '51.2', 'spread': '22.0', 'groupId': 'OG000'}, {'value': '34.0', 'spread': '10.7', 'groupId': 'OG001'}, {'value': '37.1', 'spread': '15.9', 'groupId': 'OG002'}]}]}, {'title': 'Week 28', 'denoms': [{'units': 'Participants', 'counts': [{'value': '43', 'groupId': 'OG000'}, {'value': '2', 'groupId': 'OG001'}, {'value': '5', 'groupId': 'OG002'}]}], 'categories': [{'measurements': [{'value': '7.37', 'spread': '25.0', 'groupId': 'OG000'}, {'value': '60.0', 'spread': '84.9', 'groupId': 'OG001'}, {'value': '7.54', 'spread': '16.9', 'groupId': 'OG002'}]}]}], 'paramType': 'MEAN', 'timeFrame': 'Up to week 28', 'unitOfMeasure': 'Milligrams per Liter (mg/L)', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': "The pharmacokinetic analysis set (PKAS) includes all treated participants who received any amount of study drug (active or placebo \\[SAF\\]) and had at least 1 non-missing dupilumab measurement following the first dose of study drug or placebo. The PKAS is based on the actual treatment received (as treated) rather than as randomized. Here 'n' = number of evaluable participants at a specified point in time"}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}], 'classes': [{'title': 'Treatment-Boosted Response', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'Treatment-Emergent Response', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to week 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo \\[safety analysis set\\]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time."}, {'type': 'SECONDARY', 'title': 'Number of Participants With Treatment-Emergent ADA by Maximum Titer Category', 'denoms': [{'units': 'Participants', 'counts': [{'value': '55', 'groupId': 'OG000'}, {'value': '61', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'OG001', 'title': 'Dupilumab Q2W', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}], 'classes': [{'title': 'Low (<1,000)', 'categories': [{'measurements': [{'value': '1', 'groupId': 'OG000'}, {'value': '8', 'groupId': 'OG001'}]}]}, {'title': 'Moderate (1,000 to 10,000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}, {'title': 'High (>10,000)', 'categories': [{'measurements': [{'value': '0', 'groupId': 'OG000'}, {'value': '0', 'groupId': 'OG001'}]}]}], 'paramType': 'NUMBER', 'timeFrame': 'Up to Week 28', 'unitOfMeasure': 'Participants', 'reportingStatus': 'POSTED', 'populationDescription': "The ADA analysis set (AAS) includes all treated participants who received any amount of study drug (active or placebo \\[safety analysis set\\]) and had at least one non-missing ADA result following the first dose of study drug or placebo. The ADA analysis set is based on the actual treatment received (active drug or placebo) rather than as randomized. Here 'n'= number of evaluable participants at a specified point in time."}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'FG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '66'}, {'groupId': 'FG001', 'numSubjects': '67'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '53'}, {'groupId': 'FG001', 'numSubjects': '60'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '13'}, {'groupId': 'FG001', 'numSubjects': '7'}]}], 'dropWithdraws': [{'type': 'Lost to Follow-up', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '0'}]}, {'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '7'}, {'groupId': 'FG001', 'numSubjects': '6'}]}, {'type': 'Lack of Efficacy', 'reasons': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'preAssignmentDetails': 'A total of 170 participants were screened, 37 participants failed screening, and 133 participants were randomized. Of the 37 screen failures: 2 withdrew consent, 33 did not meet inclusion/exclusion criteria, 1 was lost to follow-up and 1 was for an unknown reason.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '66', 'groupId': 'BG000'}, {'value': '67', 'groupId': 'BG001'}, {'value': '133', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'Matching Placebo', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1'}, {'id': 'BG001', 'title': 'Dupilumab Q2W', 'description': 'Administered SC Q2W, following a loading dose on Day 1'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '33.4', 'spread': '14.66', 'groupId': 'BG000'}, {'value': '35.8', 'spread': '17.07', 'groupId': 'BG001'}, {'value': '34.6', 'spread': '15.9', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'Years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '38', 'groupId': 'BG000'}, {'value': '45', 'groupId': 'BG001'}, {'value': '83', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '28', 'groupId': 'BG000'}, {'value': '22', 'groupId': 'BG001'}, {'value': '50', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Ethnicity (NIH/OMB)', 'classes': [{'categories': [{'title': 'Hispanic or Latino', 'measurements': [{'value': '2', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '5', 'groupId': 'BG002'}]}, {'title': 'Not Hispanic or Latino', 'measurements': [{'value': '63', 'groupId': 'BG000'}, {'value': '64', 'groupId': 'BG001'}, {'value': '127', 'groupId': 'BG002'}]}, {'title': 'Unknown or Not Reported', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race/Ethnicity, Customized', 'classes': [{'title': 'White', 'categories': [{'measurements': [{'value': '53', 'groupId': 'BG000'}, {'value': '53', 'groupId': 'BG001'}, {'value': '106', 'groupId': 'BG002'}]}]}, {'title': 'Black or African American', 'categories': [{'measurements': [{'value': '4', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '7', 'groupId': 'BG002'}]}]}, {'title': 'Asian', 'categories': [{'measurements': [{'value': '8', 'groupId': 'BG000'}, {'value': '9', 'groupId': 'BG001'}, {'value': '17', 'groupId': 'BG002'}]}]}, {'title': 'American Indian or Alaska Native', 'categories': [{'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '1', 'groupId': 'BG002'}]}]}, {'title': 'Other', 'categories': [{'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '1', 'groupId': 'BG001'}, {'value': '2', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-01-13', 'size': 952843, 'label': 'Study Protocol', 'hasIcf': False, 'hasSap': False, 'filename': 'Prot_000.pdf', 'typeAbbrev': 'Prot', 'uploadDate': '2023-08-28T17:32', 'hasProtocol': True}, {'date': '2022-06-27', 'size': 890151, 'label': 'Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'SAP_001.pdf', 'typeAbbrev': 'SAP', 'uploadDate': '2023-08-28T17:32', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 133}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2021-04-14', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-12', 'completionDateStruct': {'date': '2022-11-23', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2023-12-01', 'studyFirstSubmitDate': '2020-06-02', 'resultsFirstSubmitDate': '2023-08-28', 'studyFirstSubmitQcDate': '2020-06-02', 'lastUpdatePostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2023-12-01', 'studyFirstPostDateStruct': {'date': '2020-06-05', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2023-12-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of Participants With Hand and Foot Investigator Global Assessment (IGA) 0 or 1 at Week 16', 'timeFrame': 'At week 16', 'description': 'IGA is an assessment scale used to determine severity of hand and foot AD and clinical response to treatment on a 5-point scale (0 = clear; 1 = almost clear; 2 = mild; 3 = moderate; 4 = severe) based on erythema and papulation/infiltration. Higher score is indicative of more severe disease.'}], 'secondaryOutcomes': [{'measure': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus Numerical Rating Scale (NRS) of ≥4 Points From Baseline to Week 16', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)."}, {'measure': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥3 From Baseline to Week 16', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)."}, {'measure': 'Percent Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS', 'timeFrame': 'Baseline to week 16', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a patient's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)."}, {'measure': 'Percent Change in Modified Total Lesion Sign Score (mTLSS) for Hand/Foot Lesions From Baseline to Week 16', 'timeFrame': 'Baseline to Week 16', 'description': 'mTLSS combines an evaluation of hand and foot eczema lesions severity; scores are summed, extending from a base estimation of 0 (no signs or symptoms) to the most extreme of 18 (more serious disease).'}, {'measure': 'Change From Baseline to Week 16 in Weekly Average of Daily Hand and Foot Peak Pain NRS', 'timeFrame': 'Baseline to week 16', 'description': "Pain NRS Scale is an assessment tool used to report the intensity of a participant's pain. Participants will select the number between 0 and 10 that fits best to their worst pain intensity over the past 24 hours (0 = no pain and 10 = the worst pain possible)."}, {'measure': 'Mean Change From Baseline to Week 16 in Weekly Average of Daily Sleep NRS', 'timeFrame': 'Baseline to week 16', 'description': 'Sleep NRS is an 11-point scale (0 to 10) in which 0 indicates worst possible sleep while 10 indicates best possible sleep.'}, {'measure': 'Change From Baseline to Week 16 in Percent Surface Area of Hand and Foot Involvement With Atopic Dermatitis (AD)', 'timeFrame': 'Baseline to week 16'}, {'measure': 'Percent Change From Baseline to Week 4 in Weekly Average of Daily Hand and Foot Peak Pruritus NRS', 'timeFrame': 'Baseline to week 4', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)."}, {'measure': 'Percentage of Participants With Improvement (Reduction) of Weekly Average of Daily Hand and Foot Peak Pruritus NRS ≥4 From Baseline to Week 4', 'timeFrame': 'Baseline to week 4', 'description': "Pruritus NRS is an assessment tool that is used to report the intensity of a participant's pruritus (itch), both maximum and average intensity, during a 24-hour recall period; maximum itch intensity on a scale of 0 - 10 (0 = no itch; 10 = worst itch imaginable)."}, {'measure': 'Percent Change From Baseline to Week 16 in Hand Eczema Severity Index (HECSI) Score in Participants With Hand Dermatitis', 'timeFrame': 'Baseline to week 16', 'description': 'For participants with hand dermatitis HECSI is an instrument used in clinical trials to rate the severity of 6 clinical signs of hand eczema and the extent of the lesions on each of 5 hand areas by use of standard scales. The total HECSI score is based on a 4-point severity scale ranging from 0 (none/absent) to 3 (severe) and a 5-point scale rating the affected area(s) ranging from 0 (0% affected area) to 4 (76% to 100% affected area). The range for the combined HECSI score is from 0 to 360 (5x6x3x4).'}, {'measure': 'Percentage of Participants With HECSI-75 at Week 16', 'timeFrame': 'At week 16', 'description': 'HECSI-75 is defined as HECSI score has ≥75% improvement from baseline for participants with hand dermatitis.'}, {'measure': 'Percentage of Participants With HECSI-50 at Week 16', 'timeFrame': 'At week 16', 'description': 'HECSI-50 is defined as HECSI score has ≥50% improvement from baseline, for participants with hand dermatitis.'}, {'measure': 'Percentage of Participants With HECSI-90 at Week 16', 'timeFrame': 'At week 16', 'description': 'HECSI-90 is defined as HECSI score has ≥90% improvement from baseline for participants with hand dermatitis.'}, {'measure': 'Change From Baseline to Week 16 in Quality of Life in Hand Eczema Questionnaire (QOLHEQ)', 'timeFrame': 'Baseline to week 16', 'description': 'For participants with hand dermatitis, QOLHEQ is an instrument to assess disease specific Health Related Quality of Life (HRQOL) in those suffering from hand eczema. QOLHEQ overall scoring ranges as follows: 0 (best score) to 117 (worst score).'}, {'measure': 'Mean Change From Baseline to Week 16 in Work Productivity and Impairment (WPAI) and Classroom Impairment Questionnaire (CIQ)', 'timeFrame': 'Baseline to week 16', 'description': 'WPAI + CIQ is a self-administered instrument used to capture the impairment to work productivity/classroom impairment and activity due to atopic hand and foot dermatitis. The WPAI+CIQ yields 4 types of scores: absenteeism, presenteeism, work/classroom productivity loss and activity impairment. All scores range from 0 to 100% with 100% indicating total work/classroom productivity impairment and 0 no impairment at all.'}, {'measure': 'Percentage of Participants With Treatment-Emergent Adverse Events (TEAEs) Through Week 16', 'timeFrame': 'Through week 16'}, {'measure': 'Trough Concentration of Functional Dupilumab in Serum at Various Time Points', 'timeFrame': 'Up to week 28'}, {'measure': 'Number of Participants With Treatment-Emergent (TE) Anti-Drug Antibody (ADA)', 'timeFrame': 'Up to week 28'}, {'measure': 'Number of Participants With Treatment-Emergent ADA by Maximum Titer Category', 'timeFrame': 'Up to Week 28'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Moderate to Severe Atopic Hand and Foot Dermatitis']}, 'referencesModule': {'references': [{'pmid': '41240207', 'type': 'DERIVED', 'citation': 'Cohen D, Bewley A, Wollenberg A, Hong HC, Armstrong A, Jonsen E, Maslin D, Thoning H, von Eyben R, Chovatiya R. Matching-Adjusted Indirect Comparison of the Efficacy of Delgocitinib Cream and Dupilumab in the Treatment of Moderate to Severe Atopic Hand Eczema. Dermatol Ther (Heidelb). 2025 Nov 15. doi: 10.1007/s13555-025-01592-y. Online ahead of print.'}]}, 'descriptionModule': {'briefSummary': 'The primary objective of the study is to assess the efficacy of dupilumab on skin lesions in patients with atopic hand and foot dermatitis.\n\nThe secondary objectives of the study are:\n\n* To assess the efficacy of dupilumab on various other domains (pruritus, pain, sleep loss, health related QoL, work life impairment) in patients with atopic hand and foot dermatitis\n* To evaluate the safety and tolerability of dupilumab administered to patients with atopic hand and foot dermatitis\n* To evaluate systemic exposure and immunogenicity of dupilumab in patients with atopic hand and foot dermatitis'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '12 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Key Inclusion Criteria:\n\n* Patients with involvement of at least 2 anatomical areas at screening and baseline\n* Patients need to have an IGA hand and foot score of 3 or 4 (moderate-to-severe disease) at screening and baseline\n* Patients with documented recent history (within 6 months before the screening visit) of inadequate response of atopic hand and foot dermatitis to topical medication(s)\n* Patients meet the diagnosis criteria for atopic dermatitis (AD)\n* Provide informed consent/assent signed by study patient or legally acceptable representative\n* Patients need to have been compliant with the skin protection measures through the entire duration of the screening period\n\nKey Exclusion Criteria:\n\n* Treatment with dupilumab in the past\n* Patients with a positive patch test reaction that are deemed to be clinically relevant as the current cause of the hand and foot dermatitis\n* Patients with documented exposure to irritants believed to be a predominant cause of the current hand and foot dermatitis\n* Treatment with systemic corticosteroids or non-steroidal immunosuppressive drugs within 4 weeks prior to baseline\n* Known history of HIV/HBV/HCV infection\n* Pregnant or breastfeeding women or planning to become pregnant or breastfeed during the patient's participation in this study\n* Women of childbearing potential (WOCBP) who are unwilling to practice highly effective contraception prior to the initial dose/start of the first treatment and during the study\n\nNOTE: Other protocol defined inclusion / exclusion criteria apply"}, 'identificationModule': {'nctId': 'NCT04417894', 'briefTitle': 'A Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis (Liberty-AD-HAFT)', 'organization': {'class': 'INDUSTRY', 'fullName': 'Regeneron Pharmaceuticals'}, 'officialTitle': 'A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel- Group Study to Evaluate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Moderate-to-Severe Atopic Hand and Foot Dermatitis', 'orgStudyIdInfo': {'id': 'R668-AD-1924'}, 'secondaryIdInfos': [{'id': '2019-003088-22', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'dupilumab', 'description': 'Administered subcutaneously (SC) once every 2 weeks (Q2W), following a loading dose on Day 1', 'interventionNames': ['Drug: dupilumab']}, {'type': 'EXPERIMENTAL', 'label': 'Matching Placebo', 'description': 'Administered SC Q2W, following a loading dose on Day 1', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'dupilumab', 'type': 'DRUG', 'otherNames': ['DUPIXENT®', 'REGN668', 'SAR231893'], 'description': 'Solution for subcutaneous (SC) injection administration', 'armGroupLabels': ['dupilumab']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'Solution for SC injection administration', 'armGroupLabels': ['Matching Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '35209', 'city': 'Birmingham', 'state': 'Alabama', 'country': 'United States', 'facility': 'Regeneron Study 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