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

NCT03725007 | Active Not Recruiting Phase 1 FDA Drug

• 2 other identifiers: M15-3402018-000715-25
• Study Type: interventional
• Target: 124
• Locations: 10 countries
• Sites: 35

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.

Conditions

Juvenile Idiopathic Arthritis (JIA)

Keywords

Upadacitinib; ABT-494; Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)

Outcome Measures

Primary Outcomes (6)

• Treatment Emergent Adverse Events (TEAEs)

  Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.

  Up to approximately 156 weeks

• Part 1: Maximum observed plasma concentration (Cmax)

  Cmax is defined as the maximum observed plasma concentration for upadacitinib.

  Day 7

• Part 1: Time to maximum observed plasma concentration (Tmax)

  Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.

  Day 7

• Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)

  The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.

  Day 7

• Part 1: Apparent oral clearance at steady state (CL/F)

  Clearance is defined as the volume of plasma cleared of the drug per unit time.

  Day 7

• Part 1: Half-life

  Half life of updadacitinib will be determined using non-compartmental method.

  Day 7

Study Arms (5)

Participants of age group 12 to <18 years receiving dose A

EXPERIMENTAL

Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Drug: Upadacitinib

Participants of age group 12 to <18 years receiving dose B

EXPERIMENTAL

Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.

Drug: Upadacitinib

Participants of age group 6 to <12 years receiving dose A

EXPERIMENTAL

Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Drug: Upadacitinib

Participants of age group 2 to <6 years receiving dose A

EXPERIMENTAL

Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Drug: Upadacitinib

Participants of age group 2 to <18 years receiving dose A

EXPERIMENTAL

Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.

Drug: Upadacitinib

Interventions

Upadacitinib DRUG

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

Also known as: ABT-494

Participants of age group 12 to <18 years receiving dose A; Participants of age group 12 to <18 years receiving dose B; Participants of age group 2 to <18 years receiving dose A; Participants of age group 2 to <6 years receiving dose A; Participants of age group 6 to <12 years receiving dose A

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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 within the first 6 months of disease (for extended oligoarticular JIA: \<=4 joints within 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 \<=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.

You may not qualify if:

• Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
• Participant have prior exposure to JAK inhibitor.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (35)

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

Chicago, Illinois, 60611, United States

Location

Duplicate_University of Louisville /ID# 202896

Louisville, Kentucky, 40202, United States

Location

Boston Children's Hospital /ID# 202993

Boston, Massachusetts, 02115, United States

Location

Cincinnati Childrens Hospital Medical Center /ID# 209697

Cincinnati, Ohio, 45229, United States

Location

Randall Children's Hospital /ID# 213609

Portland, Oregon, 97227-1654, United States

Location

Children's Hospital of Philadelphia /ID# 209617

Philadelphia, Pennsylvania, 19146-2305, United States

Location

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

Pittsburgh, Pennsylvania, 15224-1334, United States

Location

Seattle Children's Hospital /ID# 203003

Seattle, Washington, 98105, United States

Location

Alberta Children's Hospital /ID# 251738

Calgary, Alberta, T3B 6A8, Canada

Location

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

Vancouver, British Columbia, V6H 3N1, Canada

Location

Duplicate_McGill University Health Centre /ID# 251252

Montreal, Quebec, H4A 3J1, Canada

Location

Asklepios Klinik Sankt Augustin /ID# 203264

Sankt Augustin, North Rhine-Westphalia, 53757, Germany

Location

St. Josef-Stift Sendenhorst /ID# 244740

Sendenhorst, North Rhine-Westphalia, 48324, Germany

Location

PRI - Pediatric Rheumatology Research Institute /ID# 205954

Bad Bramstedt, Schleswig-Holstein, 24576, Germany

Location

Helios Klinikum Berlin-Buch /ID# 206859

Berlin, 13125, Germany

Location

Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571

Hamburg, 22081, Germany

Location

Semmelweis Egyetem /ID# 208970

Budapest, 1085, Hungary

Location

The Chaim Sheba Medical Center /ID# 222370

Ramat Gan, Tel Aviv, 5265601, Israel

Location

Ospedale Pediatrico Bambino Gesù /ID# 203835

Rome, Roma, 00165, Italy

Location

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

Obu-shi, Aichi-ken, 474-8710, Japan

Location

Hyogo Prefectural Kobe Children's Hospital /ID# 246582

Kobe, Hyōgo, 650-0047, Japan

Location

Kagoshima University Hospital /ID# 246501

Kagoshima, Kagoshima-ken, 890-8520, Japan

Location

St Marianna University School Of Medicine /ID# 246478

Kawasaki-shi, Kanagawa, 216-8511, Japan

Location

Miyagi Children's Hospital /ID# 246734

Sendai, Miyagi, 989-3126, Japan

Location

Niigata University Medical & Dental Hospital /ID# 247246

Niigata, Niigata, 951-8520, Japan

Location

Institute of Science Tokyo Hospital /ID# 246500

Bunkyo-ku, Tokyo, 113-8519, Japan

Location

Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406

Bayamón, 00959, Puerto Rico

Location

GCM Medical Group PSC /ID# 211702

San Juan, 00917-3104, Puerto Rico

Location

Mindful Medical Research /ID# 204488

San Juan, 00918-3756, Puerto Rico

Location

Hospital Sant Joan de Deu /ID# 203915

Esplugues de Llobregat, Barcelona, 08950, Spain

Location

Hospital Infantil Universitario Nino Jesus /ID# 206466

Madrid, 28009, Spain

Location

Hospital Universitario Ramon y Cajal /ID# 203917

Madrid, 28034, Spain

Location

Hospital Universitario La Paz /ID# 203927

Madrid, 28046, Spain

Location

Hospital Universitario y Politecnico La Fe /ID# 203914

Valencia, 46026, Spain

Location

Queen Silvia Children's Hosp /ID# 251145

Gothenburg, Västra Götaland County, 416 85, Sweden

Location

MeSH Terms

Conditions

Arthritis, Juvenile

Interventions

upadacitinib

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 27, 2018
• First Posted: October 30, 2018
• Study Start: June 24, 2019
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): May 1, 2027
• Last Updated: August 5, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will not share

Locations

DE (5); ES (5); CA (3); US (8); HU (1); PR (3); IL (1); IT (1); SE (1); JP (7)