Clinical trial NCT03725007: A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
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
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: PHASE1
Conditions: Juvenile Idiopathic Arthritis (JIA)
Keywords: Upadacitinib
ABT-494
Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2018-10-30
Enrollment: 122
Sex: ALL
Minimum age (years): 2
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SEQUENTIAL
Primary purpose: TREATMENT

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.


Eligibility 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 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.

Exclusion Criteria:

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

Primary outcomes:
measure: Treatment Emergent Adverse Events (TEAEs)
timeFrame: Up to approximately 156 weeks
measure: Part 1: Maximum observed plasma concentration (Cmax)
timeFrame: Day 7
measure: Part 1: Time to maximum observed plasma concentration (Tmax)
timeFrame: Day 7
measure: Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
timeFrame: Day 7
measure: Part 1: Apparent oral clearance at steady state (CL/F)
timeFrame: Day 7
measure: Part 1: Half-life
timeFrame: Day 7
Secondary outcomes:
Other outcomes:
Locations:
city: Chicago
country: United States
facility: Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
state: Illinois
city: Louisville
country: United States
facility: Duplicate_University of Louisville /ID# 202896
state: Kentucky
city: Boston
country: United States
facility: Boston Children's Hospital /ID# 202993
state: Massachusetts
city: Cincinnati
country: United States
facility: Cincinnati Childrens Hospital Medical Center /ID# 209697
state: Ohio
city: Portland
country: United States
facility: Randall Children's Hospital /ID# 213609
state: Oregon
city: Philadelphia
country: United States
facility: Children's Hospital of Philadelphia /ID# 209617
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Children's Hospital of Pittsburgh of UPMC /ID# 202994
state: Pennsylvania
city: Seattle
country: United States
facility: Seattle Children's Hospital /ID# 203003
state: Washington
city: Calgary
country: Canada
facility: Alberta Children's Hospital /ID# 251738
state: Alberta
city: Vancouver
country: Canada
facility: British Columbia Children and Women's Hospital and Health Centre /ID# 251736
state: British Columbia
city: Montreal
country: Canada
facility: Montreal Children's Hospital /ID# 251252
state: Quebec
city: Sendenhorst
country: Germany
facility: St. Josef-Stift Sendenhorst /ID# 244740
state: Nordrhein-Westfalen
city: Bad Bramstedt
country: Germany
facility: PRI - Pediatric Rheumatology Research Institute /ID# 205954
state: Schleswig-Holstein
city: Berlin
country: Germany
facility: Helios Klinikum Berlin-Buch /ID# 206859
city: Hamburg
country: Germany
facility: Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
city: Sankt Augustin
country: Germany
facility: Asklepios Klinik Sankt Augustin /ID# 203264
city: Budapest
country: Hungary
facility: Semmelweis Egyetem /ID# 208970
city: Ramat Gan
country: Israel
facility: The Chaim Sheba Medical Center /ID# 222370
state: Tel-Aviv
city: Rome
country: Italy
facility: IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835
state: Roma
city: Obu-shi
country: Japan
facility: Aichi Children's Health and Medical Center /ID# 248327
state: Aichi
city: Kobe-shi
country: Japan
facility: Hyogo Prefectural Kobe Children's Hospital /ID# 246582
state: Hyogo
city: Kagoshima-shi
country: Japan
facility: Kagoshima University Hospital /ID# 246501
state: Kagoshima
city: Kawasaki-shi
country: Japan
facility: St. Marianna University Hospital /ID# 246478
state: Kanagawa
city: Sendai-shi
country: Japan
facility: Miyagi Children's Hospital /ID# 246734
state: Miyagi
city: Niigata-shi
country: Japan
facility: Niigata University Medical & Dental Hospital /ID# 247246
state: Niigata
city: Bunkyo-ku
country: Japan
facility: Tokyo Medical And Dental University Hospital /ID# 246500
state: Tokyo
city: Bayamon
country: Puerto Rico
facility: Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
city: San Juan
country: Puerto Rico
facility: GCM Medical Group PSC /ID# 211702
city: San Juan
country: Puerto Rico
facility: Mindful Medical Research /ID# 204488
city: Esplugues de Llobregat
country: Spain
facility: Hospital Sant Joan de Deu /ID# 203915
state: Barcelona
city: Madrid
country: Spain
facility: Hospital Infantil Universitario Nino Jesus /ID# 206466
city: Madrid
country: Spain
facility: Hospital Universitario Ramon y Cajal /ID# 203917
city: Madrid
country: Spain
facility: Hospital Universitario La Paz /ID# 203927
city: Valencia
country: Spain
facility: Hospital Universitario y Politecnico La Fe /ID# 203914
city: Gothenburg
country: Sweden
facility: Queen Silvia Children's Hosp /ID# 251145
state: Vastra Gotalands Lan
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: