Clinical trial NCT03646604: A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis
Official title: An Open-label Multiple Dose Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Subjects With Severe Atopic Dermatitis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Atopic Dermatitis
Keywords: Upadacitinib
ABT-494
Atopic Dermatitis
RINVOQ
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-08-24
Enrollment: 35
Sex: ALL
Minimum age (years): 2
Maximum age (years): 12
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility criteria: Inclusion Criteria:

* 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.

Exclusion Criteria:

* 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.

Primary outcomes:
measure: Maximum Plasma Concentration (Cmax)
timeFrame: Up to 7 days
measure: Time to Maximum Observed Plasma Concentration (Tmax)
timeFrame: Up to 7 days
measure: Area under the plasma concentration-time curve within a dosing interval (AUCtau)
timeFrame: Up to 7 days
measure: Oral Clearance
timeFrame: Up to 7 days
measure: Number of Participants With Treatment Emergent Adverse Events (TEAE)
timeFrame: Up to 2 years
Secondary outcomes:
Other outcomes:
Locations:
city: Huntington Beach
country: United States
facility: Beach Pediatrics /ID# 207834
state: California
city: Los Angeles
country: United States
facility: Children's Hospital Los Angeles /ID# 206042
state: California
city: Coral Gables
country: United States
facility: Pediatric Skin Research, LLC /ID# 213468
state: Florida
city: Fort Lauderdale
country: United States
facility: Rybear, Inc /ID# 231801
state: Florida
city: Columbus
country: United States
facility: IACT Health-Columbus /ID# 216370
state: Georgia
city: Chicago
country: United States
facility: Northwestern University Feinberg School of Medicine /ID# 206224
state: Illinois
city: Indianapolis
country: United States
facility: Dawes Fretzin, LLC /ID# 214958
state: Indiana
city: Saint Louis
country: United States
facility: Duplicate_Washington University of St. Louis /ID# 206972
state: Missouri
city: Albuquerque
country: United States
facility: University of New Mexico School of Medicine /ID# 206757
state: New Mexico
city: Cincinnati
country: United States
facility: Cincinnati Children's Hospital /ID# 207071
state: Ohio
city: Portland
country: United States
facility: Oregon Medical Research Center /ID# 206226
state: Oregon
city: Hershey
country: United States
facility: Penn State University and Milton S. Hershey Medical Center /ID# 207096
state: Pennsylvania
city: Philadelphia
country: United States
facility: Paddington Testing Co., Inc. /ID# 207079
state: Pennsylvania
city: Arlington
country: United States
facility: Arlington Research Center, Inc /ID# 222901
state: Texas
city: Morgantown
country: United States
facility: West Virginia University Hospitals /ID# 206792
state: West Virginia
city: Bergen
country: Norway
facility: Haukeland University Hospital /ID# 210162
state: Hordaland
city: Oslo
country: Norway
facility: Rikshospitalet OUS HF /ID# 210163
city: Carolina
country: Puerto Rico
facility: Alma M. Cruz Santana, MD-Private practice /ID# 214890
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: