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

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ClinicalTrials.gov Identifier: NCT03725007
Recruitment Status : Recruiting
First Posted : October 30, 2018
Last Update Posted : February 25, 2022
Sponsor:
Information provided by (Responsible Party):
AbbVie

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Juvenile Idiopathic Arthritis (JIA) Drug: Upadacitinib Phase 1

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 124 participants
Allocation: Non-Randomized
Intervention Model: Sequential Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label Multiple-Dose Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Actual Study Start Date : June 24, 2019
Estimated Primary Completion Date : February 14, 2027
Estimated Study Completion Date : February 14, 2027

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
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.
 Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494
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.
 Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494
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.
 Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494
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.
 Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494
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.
 Drug: Upadacitinib
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Other Name: ABT-494


Outcome Measures
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Primary Outcome Measures :
  1. Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to approximately 156 weeks ]
    Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

  2. Part 1: Maximum observed plasma concentration (Cmax) [ Time Frame: Day 7 ]
    Cmax is defined as the maximum observed plasma concentration for upadacitinib.

  3. Part 1: Time to maximum observed plasma concentration (Tmax) [ Time Frame: Day 7 ]
    Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.

  4. Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau) [ Time Frame: Day 7 ]
    The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.

  5. Part 1: Apparent oral clearance at steady state (CL/F) [ Time Frame: Day 7 ]
    Clearance is defined as the volume of plasma cleared of the drug per unit time.

  6. Part 1: Half-life [ Time Frame: Day 7 ]
    Half life of updadacitinib will be determined using non-compartmental method.


Eligibility Criteria
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Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Participant have total body weight of 10 kg or higher at the time of screening.
  • Participant diagnosed with pcJIA (rheumatoid factor-positive or rheumatoid factor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA with active arthritis and without active systemic features) with a history of arthritis affecting at least 5 joints during the first 6 months of disease (for extended oligoarticular JIA: <=4 joints during first 6 months of disease and >4 joints thereafter).
  • Participant have 5 or more active joints at the time of screening, defined as the presence of swollen joints (not due to deformity) or, in the absence of swelling, joints with the limitation of movement (LOM) plus pain on motion and/or tenderness with palpitation, with LOM present in at least three of the active joints.
  • If receiving methotrexate (MTX), have been taking MTX for at least 12 weeks immediately before and including Study Day 1 on a stable dose of 10 to 20 mg/m2 for at least 8 weeks before and including Study Day 1; in addition, participants should take either folic acid or folinic acid according to local standard of care.
  • If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids at a stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for at least 1 week before and including Study Day 1.

Exclusion Criteria:

  • Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
  • Participant have prior exposure to JAK inhibitor.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03725007


Contacts
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Contact: ABBVIE CALL CENTER 844-663-3742 abbvieclinicaltrials@abbvie.com

Locations
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Sponsors and Collaborators
AbbVie
Investigators
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Study Director: ABBVIE INC. AbbVie
More Information
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Responsible Party: AbbVie
ClinicalTrials.gov Identifier: NCT03725007    
Other Study ID Numbers: M15-340
2018-000715-25 ( EudraCT Number )
First Posted: October 30, 2018    Key Record Dates
Last Update Posted: February 25, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by AbbVie:
Upadacitinib
ABT-494
Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
Additional relevant MeSH terms:
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Arthritis
Arthritis, Juvenile
Joint Diseases
Musculoskeletal Diseases
Rheumatic Diseases
Connective Tissue Diseases
Autoimmune Diseases
 Immune System Diseases
Upadacitinib
Janus Kinase Inhibitors
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Antirheumatic Agents