A Study to Evaluate the Pharmacokinetics, Safety and Tolerability of Upadacitinib in Pediatric Participants With Severe Atopic Dermatitis

Part of paid clinical trials in Huntington Beach, California.

Sponsor
AbbVie
Study ID
NCT03646604
Phase
PHASE1
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
2 Years - 12 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

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.

Key Dates

Start date
Jan 31, 2019
Status verified
Feb 2025
Primary completion
Aug 29, 2024
Completion
Aug 29, 2024

Study Design

Enrollment
35 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • 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.

Primary Outcome Measure

Maximum Plasma Concentration (Cmax) [ Time Frame: Up to 7 days ]

Locations (15)

FacilityCityStateZIPSite coordinators
Beach Pediatrics /ID# 207834Huntington BeachCalifornia92647-6818-
Children's Hospital Los Angeles /ID# 206042Los AngelesCalifornia90027-
Pediatric Skin Research, LLC /ID# 213468Coral GablesFlorida33146-1837-
Rybear, Inc /ID# 231801Fort LauderdaleFlorida33316-1952-
IACT Health-Columbus /ID# 216370ColumbusGeorgia31904-8946-
Northwestern University Feinberg School of Medicine /ID# 206224ChicagoIllinois60611-2927-
Dawes Fretzin, LLC /ID# 214958IndianapolisIndiana46256-
Duplicate_Washington University of St. Louis /ID# 206972St LouisMissouri63141-6399-
University of New Mexico School of Medicine /ID# 206757AlbuquerqueNew Mexico87131-0001-
Cincinnati Children's Hospital /ID# 207071CincinnatiOhio45229-
Oregon Medical Research Center /ID# 206226PortlandOregon97239-
Penn State University and Milton S. Hershey Medical Center /ID# 207096HersheyPennsylvania17033-2360-
Paddington Testing Co., Inc. /ID# 207079PhiladelphiaPennsylvania19103-
Arlington Research Center, Inc /ID# 222901ArlingtonTexas76011-
West Virginia University Hospitals /ID# 206792MorgantownWest Virginia26506-

Find similar trials in Huntington Beach, CA

By condition
Atopic dermatitis / eczema
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Beach Pediatrics· Huntington Beach, CAChildren's Hospital Los Angeles· Los Angeles, CAPediatric Skin Research, LLC· Coral Gables, FLRybear, Inc· Fort Lauderdale, FLIACT Health-Columbus· Columbus, GANorthwestern University Feinberg School of Medicine· Chicago, IL

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