A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis

Part of paid clinical trials in Chicago, Illinois.

Sponsor
AbbVie
Study ID
NCT03725007
Phase
PHASE1
Status
Active Not Recruiting

Conditions

  • Juvenile Idiopathic Arthritis (JIA)

Eligibility Criteria

Sex
ALL
Age
2 Years - 17 Years
Healthy Volunteers
Not accepted

Interventions

  • Upadacitinib — DRUG
    Upadacitinib is administered as an oral solution or tablet as described in protocol.

Study Details

This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic arthritis. This study consists of three parts: Part 1 is multiple-cohort study that consists of two sequential multiple dose groups. Participants benefiting from the study drug with no ongoing adverse events of special interest or serious adverse events will have option to enroll in Part 2. Part 2 is open-label, long term extension study to evaluate safety and tolerability. Part 3 is an additional safety cohort to evaluate long-term safety and tolerability.

Key Dates

Start date
Jun 24, 2019
Status verified
Aug 2025
Primary completion
May 31, 2027
Completion
May 31, 2027

Study Design

Enrollment
124 participants (estimated)
Allocation
NON_RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: Participants of age group 12 to <18 years receiving dose A
    Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
  • Experimental: Participants of age group 12 to <18 years receiving dose B
    Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
  • Experimental: Participants of age group 6 to <12 years receiving dose A
    Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
  • Experimental: Participants of age group 2 to <6 years receiving dose A
    Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
  • Experimental: Participants of age group 2 to <18 years receiving dose A
    Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.

Primary Outcome Measure

Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 156 weeks ]

Locations (8)

FacilityCityStateZIPSite coordinators
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162ChicagoIllinois60611-
Duplicate_University of Louisville /ID# 202896LouisvilleKentucky40202-
Boston Children's Hospital /ID# 202993BostonMassachusetts02115-
Cincinnati Childrens Hospital Medical Center /ID# 209697CincinnatiOhio45229-
Randall Children's Hospital /ID# 213609PortlandOregon97227-1654-
Children's Hospital of Philadelphia /ID# 209617PhiladelphiaPennsylvania19146-2305-
Children's Hospital of Pittsburgh of UPMC /ID# 202994PittsburghPennsylvania15224-1334-
Seattle Children's Hospital /ID# 203003SeattleWashington98105-

Find similar trials in Chicago, IL

By research site
Ann & Robert H Lurie Children's Hospital of Chicago· Chicago, ILDuplicate_University of Louisville· Louisville, KYBoston Children's Hospital· Boston, MACincinnati Childrens Hospital Medical Center· Cincinnati, OHRandall Children's Hospital· Portland, ORChildren's Hospital of Philadelphia· Philadelphia, PA

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