Ignite Creation Date:
2025-12-25 @ 12:08 AM
Ignite Modification Date:
2025-12-25 @ 10:08 PM
Study NCT ID:
NCT05042258
Status:
RECRUITING
Last Update Posted:
2024-10-08
First Post:
2021-07-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}, {'id': 'D020447', 'term': 'Parasomnias'}], 'ancestors': [{'id': 'D012873', 'term': 'Skin Diseases, Genetic'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D003872', 'term': 'Dermatitis'}, {'id': 'D012871', 'term': 'Skin Diseases'}, {'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D017443', 'term': 'Skin Diseases, Eczematous'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}, {'id': 'D012893', 'term': 'Sleep Wake Disorders'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C582203', 'term': 'dupilumab'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2024-08-12', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-10', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-10-03', 'studyFirstSubmitDate': '2021-07-27', 'studyFirstSubmitQcDate': '2021-09-01', 'lastUpdatePostDateStruct': {'date': '2024-10-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2021-09-13', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-06', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'PROMIS (Patient Reported Outcome Measurement Information System) parent-proxy score', 'timeFrame': '12 weeks', 'description': 'Improvement from baseline in PROMIS Parent-Proxy sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation. The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.'}, {'measure': 'PROMIS patient score', 'timeFrame': '12 weeks', 'description': 'Improvement from baseline in PROMIS Patient-reported sleep disturbance score (short format 8-item) after 12 weeks post dupilumab initiation (in children ≥ 8 years old). The minimum value is "Never" and the maximum value is "Always". Higher scores mean worse outcomes.'}, {'measure': 'Wake After Sleep Onset', 'timeFrame': '12 weeks', 'description': 'Percentage of patients achieving clinically significant improvement in minutes of Wake After Sleep Onset from baseline to Week 12 on inpatient polysomnography (PSG).'}]}, 'oversightModule': {'isUsExport': True, 'oversightHasDmc': False, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Atopic Dermatitis', 'Sleep Disturbance']}, 'descriptionModule': {'briefSummary': 'Single center, prospective, Open label study of sleep, pruritus and circadian function pre/post 12-weeks of dupilumab treatment in children 6-17 years old', 'detailedDescription': 'Subjects will complete two overnight sleep studies, before and after using dupilumab for 12 weeks, to assess the effect of dupilumab on sleep disturbance in eczema patients. These overnight visits will include PSG, blood draws, skin sensors, urine collection, tape stripping, and photography. Subjects will be given dupilumab to use for 12 weeks at home before returning for the second sleep study.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '17 Years', 'minimumAge': '6 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participants, 6-17 years old at time of enrollment.\n* Moderate to severe chronic AD inadequately controlled by topical treatment, diagnosed according to Hanifin and Rajka criteria by a pediatric dermatologist or allergist.\n* AD severity will be determined at baseline with Validated Investigator Global Assessment (vIGA) score of moderate (3) or severe (4).\n* Patient assessed or parent-proxy (under 8 years old) PROMIS sleep disturbance T-score ≥60.\n* Willing and able to comply with visits and study-related procedures.\n* On stable regimens (consistent use 14 days before Day 1 of study enrollment) of inhaled corticosteroids, topical steroids, and antihistamines.\n\nExclusion Criteria:\n\n* Poorly controlled asthma (Asthma Control Test ≤19).\n* Self-reported sleep disturbance on 2 or more nights in the past 7 days due to allergic rhinitis.\n* Use of concomitant medication that causes scratching.\n* Major medical condition (such as cancer).\n* Active condition that could affect sleep, such as obstructive sleep apnea, restless leg syndrome, insomnia, narcolepsy, severe sleep disordered breathing, severe depression, COVID-19, or hives (urticaria).\n* Having applied topical steroids within 7 days of first or second PSG (important for biomarkers assessment).\n* Use of systemic immunosuppressant within 30 days of first PSG.\n* Having showered or used moisturizers within 12 hours of first or second PSG.\n* Unable to communicate in English (some PROMIS questionnaires not available in translation).\n* Other contraindication to receiving dupilumab (such as history of allergic reaction to dupilumab or any of its components).\n* Pregnancy.\n* Clinical blindness (circadian disturbing).'}, 'identificationModule': {'nctId': 'NCT05042258', 'briefTitle': 'Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis', 'organization': {'class': 'OTHER', 'fullName': 'Northwestern University'}, 'officialTitle': 'Using Dupilumab to Improve Circadian Function, Sleep and Pruritus in Children With Moderate/Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': '2021-4161'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Dupilumab administration', 'description': 'dupilumab administered in weight based dosage for 12 weeks. The drug will be administered once a week during this time through a subcutaneous injection.', 'interventionNames': ['Drug: Dupilumab']}], 'interventions': [{'name': 'Dupilumab', 'type': 'DRUG', 'otherNames': ['Dupixent'], 'description': '12 week dupilumab administration', 'armGroupLabels': ['Dupilumab administration']}]}, 'contactsLocationsModule': {'locations': [{'zip': '60611', 'city': 'Chicago', 'state': 'Illinois', 'status': 'RECRUITING', 'country': 'United States', 'facility': "Lurie Children's Hospital/Northwestern University", 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}], 'centralContacts': [{'name': 'Dermatology CTU', 'role': 'CONTACT', 'email': 'eczemasleepstudy@northwestern.edu', 'phone': '312-227-6817'}], 'overallOfficials': [{'name': 'Amy Paller, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': "Lurie Children's Hospital/Northwestern University"}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Northwestern University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Regeneron Pharmaceuticals', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Amy Paller', 'investigatorAffiliation': 'Northwestern University'}}}}