Accepts Healthy Volunteers
Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms
An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.
An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.
Searching Both is inclusive of interventional and observational studies.
|Eligible Ages||2 Years - 12 Years|
- - Participants with total body weight of 10 kilograms(kg) or higher at Baseline.
- - Diagnosed with atopic dermatitis (AD) with onset of symptoms at least 6 months prior to baseline.
- - Meets Hanifin and Rajka criteria for AD.
- - Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).
- - 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.
- - Prior exposure to Janus Kinase (JAK) inhibitor.
- - Requirement of prohibited medications during the study.
- - 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.
This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.
Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.
Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.
Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.
Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.
The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.
The person who is responsible for the scientific and technical direction of the entire clinical study.
|Principal Investigator Affiliation||AbbVie|
Category of organization(s) involved as sponsor (and collaborator) supporting the trial.
|Countries||Norway, Puerto Rico, United States|
The disease, disorder, syndrome, illness, or injury that is being studied.
|Study Website:||View Trial Website|
Experimental: Part 1; Cohort 1
Participants, 6 to <12 years of age, will receive low dose of upadacitinib.
Experimental: Part 1; Cohort 2
Participants, 6 to <12 years of age, will receive high dose of upadacitinib.
Experimental: Part 1; Cohort 3
Participants, 2 to <6 years of age, will receive low dose of upadacitinib.
Experimental: Part 1; Cohort 4
Participants, 2 to <6 years of age, will receive high dose of upadacitinib.
Experimental: Part 2
Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
Drug: - Upadacitinib (ABT-494)
Upadacitinib will be administered orally.
Contact a Trial Team
If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.