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

Study Purpose

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 two parts: Part 1 is multiple-cohort study that consists of two sequential multiple-ascending 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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 2 Years - 17 Years
Gender All
More Inclusion & Exclusion 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 an 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.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT03725007
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 1
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

AbbVie
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

AbbVie Inc.
Principal Investigator Affiliation AbbVie
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Germany, Hungary, Israel, Italy, Puerto Rico, Spain, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Juvenile Idiopathic Arthritis (JIA)
Arms & Interventions

Arms

Experimental: Participants of age group 2 to <6 years receiving dose B

Participants of age group 2 to <6 years administered with upadacitinib dose B(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 6 to <12 years receiving dose B

Participants of age group 6 to <12 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 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 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

Interventions

Drug: - Upadacitinib

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

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Chicago, Illinois

Status

Recruiting

Address

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

Chicago, Illinois, 60611

University of Louisville /ID# 202896, Louisville, Kentucky

Status

Completed

Address

University of Louisville /ID# 202896

Louisville, Kentucky, 40202

Boston Childrens Hospital /ID# 202993, Boston, Massachusetts

Status

Recruiting

Address

Boston Childrens Hospital /ID# 202993

Boston, Massachusetts, 02115

Cincinnati, Ohio

Status

Recruiting

Address

Cincinnati Childrens Hosp Med /ID# 209697

Cincinnati, Ohio, 45229

Randall Children's Hospital /ID# 213609, Portland, Oregon

Status

Recruiting

Address

Randall Children's Hospital /ID# 213609

Portland, Oregon, 97227-1654

Philadelphia, Pennsylvania

Status

Recruiting

Address

Children's Hospital of Philadelphia /ID# 209617

Philadelphia, Pennsylvania, 19146-2305

Pittsburgh, Pennsylvania

Status

Recruiting

Address

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

Pittsburgh, Pennsylvania, 15224-1334

Seattle Children's Hospital /ID# 203003, Seattle, Washington

Status

Recruiting

Address

Seattle Children's Hospital /ID# 203003

Seattle, Washington, 98105

International Sites

Bad Bramstedt, Germany

Status

Recruiting

Address

PRI - Pediatric Rheumatology Research Institute /ID# 205954

Bad Bramstedt, , 24576

Helios Klinikum Berlin Buch /ID# 206859, Berlin, Germany

Status

Completed

Address

Helios Klinikum Berlin Buch /ID# 206859

Berlin, , 13125

Hamburg, Germany

Status

Recruiting

Address

Kinder- & Jugendrheumatologie /ID# 206571

Hamburg, , 22081

Sankt Augustin, Germany

Status

Recruiting

Address

Asklepios Klinik St. Augustin /ID# 203264

Sankt Augustin, , 53757

Budapest VIII, Pest, Hungary

Status

Recruiting

Address

Semmelweis Egyetem II. Számú Gyermekgyógyászati Klinika /ID# 208970

Budapest VIII, Pest, 1082

Sheba Medical Center /ID# 222370, Ramat Gan, Israel

Status

Not yet recruiting

Address

Sheba Medical Center /ID# 222370

Ramat Gan, , 5239424

Rome, Lazio, Italy

Status

Recruiting

Address

IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835

Rome, Lazio, 00165

IRCCS Istituto G. Gaslini /ID# 203648, Genoa, Italy

Status

Not yet recruiting

Address

IRCCS Istituto G. Gaslini /ID# 203648

Genoa, , 16147

Bayamon, Puerto Rico

Status

Completed

Address

Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406

Bayamon, , 00959

San Juan, Puerto Rico

Status

Recruiting

Address

GCM Medical Group PSC - Hato Rey /ID# 211702

San Juan, , 00917-3104

Mindful Medical Research /ID# 204488, San Juan, Puerto Rico

Status

Completed

Address

Mindful Medical Research /ID# 204488

San Juan, , 00918-3756

Hospital Sant Joan de Deu /ID# 203915, Esplugues de Llobregat, Barcelona, Spain

Status

Recruiting

Address

Hospital Sant Joan de Deu /ID# 203915

Esplugues de Llobregat, Barcelona, 08950

Madrid, Spain

Status

Recruiting

Address

Hospital Infantil Universitario Nino Jesus /ID# 206466

Madrid, , 28009

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario Ramon y Cajal /ID# 203917

Madrid, , 28034

Madrid, Spain

Status

Recruiting

Address

Hospital Universitario La Paz /ID# 203927

Madrid, , 28046

Valencia, Spain

Status

Recruiting

Address

Hospital Universitario y Politecnico La Fe /ID# 203914

Valencia, , 46026