Ignite Creation Date:
2025-12-24 @ 7:58 PM
Ignite Modification Date:
2026-03-29 @ 11:34 AM
Study NCT ID:
NCT03646604
Status:
COMPLETED
Last Update Posted:
2025-02-10
First Post:
2018-08-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'removedCountries': ['Ireland', 'Netherlands']}, 'conditionBrowseModule': {'meshes': [{'id': 'D003876', 'term': 'Dermatitis, Atopic'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'C000613732', 'term': 'upadacitinib'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SEQUENTIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 35}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-02', 'completionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-02-06', 'studyFirstSubmitDate': '2018-08-23', 'studyFirstSubmitQcDate': '2018-08-23', 'lastUpdatePostDateStruct': {'date': '2025-02-10', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-08-29', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Maximum Plasma Concentration (Cmax)', 'timeFrame': 'Up to 7 days', 'description': 'It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.'}, {'measure': 'Time to Maximum Observed Plasma Concentration (Tmax)', 'timeFrame': 'Up to 7 days', 'description': 'It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.'}, {'measure': 'Area under the plasma concentration-time curve within a dosing interval (AUCtau)', 'timeFrame': 'Up to 7 days', 'description': 'The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.'}, {'measure': 'Oral Clearance', 'timeFrame': 'Up to 7 days', 'description': 'Clearance is defined the volume of plasma cleared of the drug per unit time.'}, {'measure': 'Number of Participants With Treatment Emergent Adverse Events (TEAE)', 'timeFrame': 'Up to 2 years', 'description': 'An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug as either probably related, possibly related, probably not related or not related. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events (TEAEs) are defined as any event that began or worsened in severity after the first dose of study drug.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': True, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Upadacitinib', 'ABT-494', 'Atopic Dermatitis', 'RINVOQ'], 'conditions': ['Atopic Dermatitis']}, 'referencesModule': {'references': [{'pmid': '39142926', 'type': 'DERIVED', 'citation': 'Qian Y, Raymundo EM, Hao S, Unnebrink K, Levy GF, Teixeira HD, Chu AD, Zinn ZA, Paller AS, Liu W, Mohamed MF. Pharmacokinetics, Safety, Tolerability, and Exploratory Efficacy of Upadacitinib in Children with Severe Atopic Dermatitis. Clin Ther. 2024 Oct;46(10):733-741. doi: 10.1016/j.clinthera.2024.07.003. Epub 2024 Aug 13.'}], 'seeAlsoLinks': [{'url': 'https://www.abbvieclinicaltrials.com/study/?id=M16-049#additional-resources-section', 'label': 'clinical study report synopsis'}]}, 'descriptionModule': {'briefSummary': 'The objective of this study is to evaluate the safety, pharmacokinetics and tolerability of multiple doses of upadacitinib in pediatric participants with severe atopic dermatitis and to evaluate palatability of upadacitinib oral solution in pediatric participants.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD'], 'maximumAge': '12 Years', 'minimumAge': '2 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Participants with total body weight of 10 kilograms(kg) or higher at Baseline. Beginning with protocol version 6.0, only subjects 3 years of age and older will be enrolled for the remainder of this study.\n* Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.\n* Meets Hanifin and Rajka criteria for AD.\n* Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).\n* Documented history (within 12 months prior to the Baseline Visit) of inadequate response or intolerance to topical corticosteroids (TCS) and topical calcineurin inhibitor (TCI) OR for whom use of TCS and TCIs is otherwise medically inadvisable.\n\nExclusion Criteria:\n\n* Prior exposure to Janus Kinase (JAK) inhibitor.\n* Requirement of prohibited medications during the study.\n* Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study."}, 'identificationModule': {'nctId': 'NCT03646604', 'briefTitle': 'A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis', 'organization': {'class': 'INDUSTRY', 'fullName': 'AbbVie'}, 'officialTitle': 'An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis', 'orgStudyIdInfo': {'id': 'M16-049'}, 'secondaryIdInfos': [{'id': '2018-004409-17', 'type': 'EUDRACT_NUMBER'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Part 1; Cohort 1', 'description': 'Participants, 6 to \\<12 years of age, will receive low dose of upadacitinib.', 'interventionNames': ['Drug: Upadacitinib (ABT-494)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1; Cohort 2', 'description': 'Participants, 6 to \\<12 years of age, will receive high dose of upadacitinib.', 'interventionNames': ['Drug: Upadacitinib (ABT-494)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1; Cohort 3', 'description': 'Participants, 2 to \\<6 years of age, will receive low dose of upadacitinib.', 'interventionNames': ['Drug: Upadacitinib (ABT-494)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 1; Cohort 4', 'description': 'Participants, 2 to \\<6 years of age, will receive high dose of upadacitinib.', 'interventionNames': ['Drug: Upadacitinib (ABT-494)']}, {'type': 'EXPERIMENTAL', 'label': 'Part 2', 'description': 'Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.', 'interventionNames': ['Drug: Upadacitinib (ABT-494)']}], 'interventions': [{'name': 'Upadacitinib (ABT-494)', 'type': 'DRUG', 'otherNames': ['ABT-494', 'RINVOQ'], 'description': 'Upadacitinib will be administered orally.', 'armGroupLabels': ['Part 1; Cohort 1', 'Part 1; Cohort 2', 'Part 1; Cohort 3', 'Part 1; Cohort 4', 'Part 2']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92647-6818', 'city': 'Huntington Beach', 'state': 'California', 'country': 'United States', 'facility': 'Beach Pediatrics /ID# 207834', 'geoPoint': {'lat': 33.6603, 'lon': -117.99923}}, {'zip': '90027', 'city': 'Los Angeles', 'state': 'California', 'country': 'United States', 'facility': "Children's Hospital Los Angeles /ID# 206042", 'geoPoint': {'lat': 34.05223, 'lon': -118.24368}}, {'zip': '33146-1837', 'city': 'Coral Gables', 'state': 'Florida', 'country': 'United States', 'facility': 'Pediatric Skin Research, LLC /ID# 213468', 'geoPoint': {'lat': 25.72149, 'lon': -80.26838}}, {'zip': '33316-1952', 'city': 'Fort Lauderdale', 'state': 'Florida', 'country': 'United States', 'facility': 'Rybear, Inc /ID# 231801', 'geoPoint': {'lat': 26.12231, 'lon': -80.14338}}, {'zip': '31904-8946', 'city': 'Columbus', 'state': 'Georgia', 'country': 'United States', 'facility': 'IACT Health-Columbus /ID# 216370', 'geoPoint': {'lat': 32.46098, 'lon': -84.98771}}, {'zip': '60611-2927', 'city': 'Chicago', 'state': 'Illinois', 'country': 'United States', 'facility': 'Northwestern University Feinberg School of Medicine /ID# 206224', 'geoPoint': {'lat': 41.85003, 'lon': -87.65005}}, {'zip': '46256', 'city': 'Indianapolis', 'state': 'Indiana', 'country': 'United States', 'facility': 'Dawes Fretzin, LLC /ID# 214958', 'geoPoint': {'lat': 39.76838, 'lon': -86.15804}}, {'zip': '63141-6399', 'city': 'St Louis', 'state': 'Missouri', 'country': 'United States', 'facility': 'Duplicate_Washington University of St. Louis /ID# 206972', 'geoPoint': {'lat': 38.62727, 'lon': -90.19789}}, {'zip': '87131-0001', 'city': 'Albuquerque', 'state': 'New Mexico', 'country': 'United States', 'facility': 'University of New Mexico School of Medicine /ID# 206757', 'geoPoint': {'lat': 35.08449, 'lon': -106.65114}}, {'zip': '45229', 'city': 'Cincinnati', 'state': 'Ohio', 'country': 'United States', 'facility': "Cincinnati Children's Hospital /ID# 207071", 'geoPoint': {'lat': 39.12711, 'lon': -84.51439}}, {'zip': '97239', 'city': 'Portland', 'state': 'Oregon', 'country': 'United States', 'facility': 'Oregon Medical Research Center /ID# 206226', 'geoPoint': {'lat': 45.52345, 'lon': -122.67621}}, {'zip': '17033-2360', 'city': 'Hershey', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Penn State University and Milton S. Hershey Medical Center /ID# 207096', 'geoPoint': {'lat': 40.28592, 'lon': -76.65025}}, {'zip': '19103', 'city': 'Philadelphia', 'state': 'Pennsylvania', 'country': 'United States', 'facility': 'Paddington Testing Co., Inc. /ID# 207079', 'geoPoint': {'lat': 39.95238, 'lon': -75.16362}}, {'zip': '76011', 'city': 'Arlington', 'state': 'Texas', 'country': 'United States', 'facility': 'Arlington Research Center, Inc /ID# 222901', 'geoPoint': {'lat': 32.73569, 'lon': -97.10807}}, {'zip': '26506', 'city': 'Morgantown', 'state': 'West Virginia', 'country': 'United States', 'facility': 'West Virginia University Hospitals /ID# 206792', 'geoPoint': {'lat': 39.62953, 'lon': -79.9559}}, {'zip': '5021', 'city': 'Bergen', 'state': 'Hordaland', 'country': 'Norway', 'facility': 'Haukeland University Hospital /ID# 210162', 'geoPoint': {'lat': 60.39299, 'lon': 5.32415}}, {'zip': '0450', 'city': 'Oslo', 'country': 'Norway', 'facility': 'Rikshospitalet OUS HF /ID# 210163', 'geoPoint': {'lat': 59.91273, 'lon': 10.74609}}, {'zip': '00985', 'city': 'Carolina', 'country': 'Puerto Rico', 'facility': 'Alma M. Cruz Santana, MD-Private practice /ID# 214890', 'geoPoint': {'lat': 18.38078, 'lon': -65.95739}}], 'overallOfficials': [{'name': 'ABBVIE INC.', 'role': 'STUDY_DIRECTOR', 'affiliation': 'AbbVie'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'AbbVie', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}