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

Juvenile Idiopathic Arthritis (JIA) Clinical Trial

— SELECT-YOUTH  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03725007
• Other study ID #: M15-340
• Secondary ID: 2018-000715-25
• Status: Active, not recruiting
• Phase: Phase 1
• Start date: June 24, 2019
• Est. completion date: May 5, 2027

Study information

• Verified date: June 2024
• Source: AbbVie
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 122
• Est. completion date: May 5, 2027
• Est. primary completion date: May 5, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 17 Years

Eligibility

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.

Related Conditions & MeSH terms

• Arthritis
• Arthritis, Juvenile
• Juvenile Idiopathic Arthritis (JIA)

Intervention

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

Locations

Country	Name	City	State
Canada	Alberta Children's Hospital /ID# 251738	Calgary	Alberta
Canada	Montreal Children's Hospital /ID# 251252	Montreal	Quebec
Canada	British Columbia Children and Women's Hospital and Health Centre /ID# 251736	Vancouver	British Columbia
Germany	PRI - Pediatric Rheumatology Research Institute /ID# 205954	Bad Bramstedt	Schleswig-Holstein
Germany	Helios Klinikum Berlin-Buch /ID# 206859	Berlin
Germany	Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571	Hamburg
Germany	Asklepios Klinik Sankt Augustin /ID# 203264	Sankt Augustin
Germany	St. Josef-Stift Sendenhorst /ID# 244740	Sendenhorst	Nordrhein-Westfalen
Hungary	Semmelweis Egyetem /ID# 208970	Budapest
Israel	The Chaim Sheba Medical Center /ID# 222370	Ramat Gan	Tel-Aviv
Italy	IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835	Rome	Roma
Japan	Tokyo Medical And Dental University Hospital /ID# 246500	Bunkyo-ku	Tokyo
Japan	Kagoshima University Hospital /ID# 246501	Kagoshima-shi	Kagoshima
Japan	St. Marianna University Hospital /ID# 246478	Kawasaki-shi	Kanagawa
Japan	Hyogo Prefectural Kobe Children's Hospital /ID# 246582	Kobe-shi	Hyogo
Japan	Niigata University Medical & Dental Hospital /ID# 247246	Niigata-shi	Niigata
Japan	Aichi Children's Health and Medical Center /ID# 248327	Obu-shi	Aichi
Japan	Miyagi Children's Hospital /ID# 246734	Sendai-shi	Miyagi
Puerto Rico	Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406	Bayamon
Puerto Rico	GCM Medical Group PSC /ID# 211702	San Juan
Puerto Rico	Mindful Medical Research /ID# 204488	San Juan
Spain	Hospital Sant Joan de Deu /ID# 203915	Esplugues de Llobregat	Barcelona
Spain	Hospital Infantil Universitario Nino Jesus /ID# 206466	Madrid
Spain	Hospital Universitario La Paz /ID# 203927	Madrid
Spain	Hospital Universitario Ramon y Cajal /ID# 203917	Madrid
Spain	Hospital Universitario y Politecnico La Fe /ID# 203914	Valencia
Sweden	Queen Silvia Children's Hosp /ID# 251145	Gothenburg	Vastra Gotalands Lan
United States	Boston Children's Hospital /ID# 202993	Boston	Massachusetts
United States	Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162	Chicago	Illinois
United States	Cincinnati Childrens Hospital Medical Center /ID# 209697	Cincinnati	Ohio
United States	Duplicate_University of Louisville /ID# 202896	Louisville	Kentucky
United States	Children's Hospital of Philadelphia /ID# 209617	Philadelphia	Pennsylvania
United States	Children's Hospital of Pittsburgh of UPMC /ID# 202994	Pittsburgh	Pennsylvania
United States	Randall Children's Hospital /ID# 213609	Portland	Oregon
United States	Seattle Children's Hospital /ID# 203003	Seattle	Washington

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Countries where clinical trial is conducted

United States,  Canada,  Germany,  Hungary,  Israel,  Italy,  Japan,  Puerto Rico,  Spain,  Sweden, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Part 1: Maximum observed plasma concentration (Cmax)	Cmax is defined as the maximum observed plasma concentration for upadacitinib.	Day 7
Primary	Part 1: Time to maximum observed plasma concentration (Tmax)	Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.	Day 7
Primary	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
Primary	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
Primary	Part 1: Half-life	Half life of updadacitinib will be determined using non-compartmental method.	Day 7