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

Last updated: June 18, 2024
Sponsor: AbbVie
Overall Status: Active - Not Recruiting

Phase

1

Condition

Joint Injuries

Treatment

Upadacitinib

Clinical Study ID

NCT03725007
M15-340
2018-000715-25
  • Ages 2-17
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

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 rheumatoidfactor-negative polyarticular JIA, extended oligoarticular JIA, or systemic JIA withactive arthritis and without active systemic features) with a history of arthritisaffecting at least 5 joints within the first 6 months of disease (for extendedoligoarticular JIA: <=4 joints within first 6 months of disease and >4 jointsthereafter).

  • Participant have 5 or more active joints at the time of screening, defined as thepresence 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 tendernesswith palpitation, with LOM present in at least three of the active joints.

  • If receiving methotrexate (MTX), have been taking MTX for at least 12 weeksimmediately before and including Study Day 1 on a stable dose of <=20 mg/m2 for atleast 8 weeks before and including Study Day 1; in addition, participants shouldtake either folic acid or folinic acid according to local standard of care.

  • If on oral glucocorticosteroids, must have been taking oral glucocorticosteroids ata stable dose (no greater than 10 mg/day or 0.2 mg/kg/day, whatever is lower) for atleast 1 week before and including Study Day 1.

Exclusion

Exclusion Criteria:

  • Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenilepsoriatic arthritis (JPSA).

  • Participant have prior exposure to JAK inhibitor.

Study Design

Total Participants: 122
Treatment Group(s): 1
Primary Treatment: Upadacitinib
Phase: 1
Study Start date:
June 24, 2019
Estimated Completion Date:
May 05, 2027

Connect with a study center

  • Alberta Children's Hospital /ID# 251738

    Calgary, Alberta T3B 6A8
    Canada

    Site Not Available

  • BC Children and Women's Hospital and Health Centre /ID# 251736

    Vancouver, British Columbia V6H 3N1
    Canada

    Active - Recruiting

  • British Columbia Children and Women's Hospital and Health Centre /ID# 251736

    Vancouver, British Columbia V6H 3N1
    Canada

    Site Not Available

  • Montreal Children's Hospital /ID# 251252

    Montreal, Quebec H4A 3J1
    Canada

    Site Not Available

  • St. Josef-Stift Sendenhorst /ID# 244740

    Sendenhorst, Nordrhein-Westfalen 48324
    Germany

    Site Not Available

  • PRI - Pediatric Rheumatology Research Institute /ID# 205954

    Bad Bramstedt, Schleswig-Holstein 24576
    Germany

    Site Not Available

  • Helios Klinikum Berlin-Buch /ID# 206859

    Berlin, 13125
    Germany

    Site Not Available

  • Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571

    Hamburg, 22081
    Germany

    Site Not Available

  • Asklepios Klinik Sankt Augustin /ID# 203264

    Sankt Augustin, 53757
    Germany

    Site Not Available

  • Semmelweis Egyetem II. Számú Gyermekgyógyászati Klinika /ID# 208970

    Budapest VIII, Pest 1082
    Hungary

    Site Not Available

  • Semmelweis Egyetem /ID# 208970

    Budapest, 1085
    Hungary

    Site Not Available

  • The Chaim Sheba Medical Center /ID# 222370

    Ramat Gan, Tel-Aviv 5265601
    Israel

    Site Not Available

  • IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835

    Rome, Roma 00165
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer /ID# 215576

    Florence, 50139
    Italy

    Site Not Available

  • IRCCS Istituto G. Gaslini /ID# 203648

    Genoa, 16148
    Italy

    Site Not Available

  • Aichi Children's Health and Medical Center /ID# 248327

    Obu-shi, Aichi 474-8710
    Japan

    Site Not Available

  • Hyogo Prefectural Kobe Children's Hospital /ID# 246582

    Kobe-shi, Hyogo 650-0047
    Japan

    Site Not Available

  • Kagoshima University Hospital /ID# 246501

    Kagoshima-shi, Kagoshima 890-8520
    Japan

    Site Not Available

  • St. Marianna University Hospital /ID# 246478

    Kawasaki-shi, Kanagawa 216-8511
    Japan

    Site Not Available

  • Miyagi Children's Hospital /ID# 246734

    Sendai-shi, Miyagi 989-3126
    Japan

    Site Not Available

  • Niigata University Medical & Dental Hospital /ID# 247246

    Niigata-shi, Niigata 951-8520
    Japan

    Site Not Available

  • Tokyo Medical And Dental University Hospital /ID# 246500

    Bunkyo-ku, Tokyo 113-8519
    Japan

    Site Not Available

  • Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406

    Bayamon, 00959
    Puerto Rico

    Site Not Available

  • GCM Medical Group PSC /ID# 211702

    San Juan, 00917-3104
    Puerto Rico

    Site Not Available

  • Mindful Medical Research /ID# 204488

    San Juan, 00918-3756
    Puerto Rico

    Site Not Available

  • Hospital Sant Joan de Deu /ID# 203915

    Esplugues de Llobregat, Barcelona 08950
    Spain

    Site Not Available

  • Hospital Infantil Universitario Nino Jesus /ID# 206466

    Madrid, 28009
    Spain

    Site Not Available

  • Hospital Universitario La Paz /ID# 203927

    Madrid, 28046
    Spain

    Site Not Available

  • Hospital Universitario Ramon y Cajal /ID# 203917

    Madrid, 28034
    Spain

    Site Not Available

  • Hospital Universitario y Politecnico La Fe /ID# 203914

    Valencia, 46026
    Spain

    Site Not Available

  • Queen Silvia Children's Hosp /ID# 251145

    Gothenburg, Vastra Gotalands Lan 416 85
    Sweden

    Site Not Available

  • Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Duplicate_University of Louisville /ID# 202896

    Louisville, Kentucky 40202
    United States

    Site Not Available

  • University of Louisville /ID# 202896

    Louisville, Kentucky 40202
    United States

    Completed

  • Boston Children's Hospital /ID# 202993

    Boston, Massachusetts 02115
    United States

    Site Not Available

  • University of Minnesota - Pediatrics/Rheumatology /ID# 202897

    Minneapolis, Minnesota 55454-1450
    United States

    Site Not Available

  • Cincinnati Childrens Hospital Medical Center /ID# 209697

    Cincinnati, Ohio 45229
    United States

    Site Not Available

  • Randall Children's Hospital /ID# 213609

    Portland, Oregon 97227-1654
    United States

    Site Not Available

  • Children's Hospital of Philadelphia /ID# 209617

    Philadelphia, Pennsylvania 19146-2305
    United States

    Site Not Available

  • Children's Hospital of Pittsburgh of UPMC /ID# 202994

    Pittsburgh, Pennsylvania 15224-1334
    United States

    Site Not Available

  • Seattle Children's Hospital /ID# 203003

    Seattle, Washington 98105
    United States

    Site Not Available

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