A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
- Registration Number
- NCT03646604
- Lead Sponsor
- AbbVie
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- All
- Target Recruitment
- 32
- 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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SEQUENTIAL
- Arm && Interventions
Group Intervention Description Part 1; Cohort 3 Upadacitinib (ABT-494) Participants, 2 to \<6 years of age, will receive low dose of upadacitinib. Part 1; Cohort 1 Upadacitinib (ABT-494) Participants, 6 to \<12 years of age, will receive low dose of upadacitinib. Part 1; Cohort 2 Upadacitinib (ABT-494) Participants, 6 to \<12 years of age, will receive high dose of upadacitinib. Part 1; Cohort 4 Upadacitinib (ABT-494) Participants, 2 to \<6 years of age, will receive high dose of upadacitinib. Part 2 Upadacitinib (ABT-494) Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.
- Primary Outcome Measures
Name Time Method Maximum Plasma Concentration (Cmax) Up to 7 days It is defined as the maximum observed plasma concentration (Cmax) for upadacitinib.
Time to Maximum Observed Plasma Concentration (Tmax) Up to 7 days It is defined as the time to maximum plasma concentration (Tmax) of upadacitinib.
Oral Clearance Up to 7 days Clearance is defined the volume of plasma cleared of the drug per unit time.
Area under the plasma concentration-time curve within a dosing interval (AUCtau) Up to 7 days The area under the plasma concentration-time curve (AUCtau) is a method of measurement of the total exposure of a drug in plasma.
Number of Participants With Treatment Emergent Adverse Events (TEAE) Up to 2 years 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.
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (18)
Children's Hospital Los Angeles /ID# 206042
🇺🇸Los Angeles, California, United States
Cincinnati Children's Hospital /ID# 207071
🇺🇸Cincinnati, Ohio, United States
Beach Pediatrics /ID# 207834
🇺🇸Huntington Beach, California, United States
Rybear, Inc /ID# 231801
🇺🇸Fort Lauderdale, Florida, United States
Northwestern University Feinberg School of Medicine /ID# 206224
🇺🇸Chicago, Illinois, United States
Dawes Fretzin, LLC /ID# 214958
🇺🇸Indianapolis, Indiana, United States
IACT Health-Columbus /ID# 216370
🇺🇸Columbus, Georgia, United States
Duplicate_Washington University of St. Louis /ID# 206972
🇺🇸Saint Louis, Missouri, United States
Penn State University and Milton S. Hershey Medical Center /ID# 207096
🇺🇸Hershey, Pennsylvania, United States
Arlington Research Center, Inc /ID# 222901
🇺🇸Arlington, Texas, United States
University of New Mexico School of Medicine /ID# 206757
🇺🇸Albuquerque, New Mexico, United States
West Virginia University Hospitals /ID# 206792
🇺🇸Morgantown, West Virginia, United States
Haukeland University Hospital /ID# 210162
🇳🇴Bergen, Hordaland, Norway
Rikshospitalet OUS HF /ID# 210163
🇳🇴Oslo, Norway
Alma M. Cruz Santana, MD-Private practice /ID# 214890
🇵🇷Carolina, Puerto Rico
Pediatric Skin Research, LLC /ID# 213468
🇺🇸Coral Gables, Florida, United States
Paddington Testing Co., Inc. /ID# 207079
🇺🇸Philadelphia, Pennsylvania, United States
Oregon Medical Research Center /ID# 206226
🇺🇸Portland, Oregon, United States