Back to resultsA Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis (SELECT-YOUTH)
Primary Purpose
Juvenile Idiopathic Arthritis (JIA)
Status
Recruiting
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
Upadacitinib
Sponsored by
About this trial
This is an interventional treatment trial for Juvenile Idiopathic Arthritis (JIA) focused on measuring Upadacitinib, ABT-494, Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
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 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 a 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.
Sites / Locations
- Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162Recruiting
- University of Louisville /ID# 202896
- Boston Children's Hospital /ID# 202993
- Cincinnati Childrens Hospital Medical Center /ID# 209697Recruiting
- Randall Children's Hospital /ID# 213609Recruiting
- Children's Hospital of Philadelphia /ID# 209617Recruiting
- Children's Hospital of Pittsburgh of UPMC /ID# 202994
- Seattle Children's Hospital /ID# 203003Recruiting
- St. Josef-Stift Sendenhorst /ID# 244740Recruiting
- PRI - Pediatric Rheumatology Research Institute /ID# 205954
- Helios Klinikum Berlin-Buch /ID# 206859
- Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571Recruiting
- Asklepios Klinik Sankt Augustin /ID# 203264Recruiting
- Semmelweis Egyetem /ID# 208970Recruiting
- The Chaim Sheba Medical Center /ID# 222370Recruiting
- IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835Recruiting
- Aichi Children's Health and Medical Center /ID# 248327Recruiting
- Hyogo Prefectural Kobe Children's Hospital /ID# 246582Recruiting
- Kagoshima University Hospital /ID# 246501Recruiting
- St. Marianna University Hospital /ID# 246478Recruiting
- Miyagi Children's Hospital /ID# 246734Recruiting
- Niigata University Medical & Dental Hospital /ID# 247246Recruiting
- Tokyo Medical And Dental University Hospital /ID# 246500Recruiting
- Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
- GCM Medical Group PSC /ID# 211702Recruiting
- Mindful Medical Research /ID# 204488
- Hospital Sant Joan de Deu /ID# 203915Recruiting
- Hospital Infantil Universitario Nino Jesus /ID# 206466
- Hospital Universitario Ramon y Cajal /ID# 203917Recruiting
- Hospital Universitario La Paz /ID# 203927Recruiting
- Hospital Universitario y Politecnico La Fe /ID# 203914Recruiting
- Queen Silvia Children's Hosp /ID# 251145Recruiting
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm 5
Arm Type
Experimental
Experimental
Experimental
Experimental
Experimental
Arm Label
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 6 to <12 years receiving dose A
Participants of age group 2 to <6 years receiving dose A
Participants of age group 2 to <18 years receiving dose A
Arm Description
Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Participants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol.
Outcomes
Primary Outcome Measures
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.
Part 1: Maximum observed plasma concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Part 1: Time to maximum observed plasma concentration (Tmax)
Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
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.
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.
Part 1: Half-life
Half life of updadacitinib will be determined using non-compartmental method.
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03725007
Brief Title
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
Acronym
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 24, 2019 (Actual)
Primary Completion Date
August 17, 2027 (Anticipated)
Study Completion Date
August 17, 2027 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Juvenile Idiopathic Arthritis (JIA)
Keywords
Upadacitinib, ABT-494, Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
124 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Participants of age group 12 to <18 years receiving dose A
Arm Type
Experimental
Arm Description
Participants of age group 12 to <18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Arm Title
Participants of age group 12 to <18 years receiving dose B
Arm Type
Experimental
Arm Description
Participants of age group 12 to <18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.
Arm Title
Participants of age group 6 to <12 years receiving dose A
Arm Type
Experimental
Arm Description
Participants of age group 6 to <12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Arm Title
Participants of age group 2 to <6 years receiving dose A
Arm Type
Experimental
Arm Description
Participants of age group 2 to <6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.
Arm Title
Participants of age group 2 to <18 years receiving dose A
Arm Type
Experimental
Arm Description
Participants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol.
Intervention Type
Drug
Intervention Name(s)
Upadacitinib
Other Intervention Name(s)
ABT-494
Intervention Description
Upadacitinib is administered as an oral solution or tablet as described in protocol.
Primary Outcome Measure Information:
Title
Treatment Emergent Adverse Events (TEAEs)
Description
Adverse Event is defined as any unfavorable and unintended sign, symptom, or disease temporally associated with the use of a medicinal product.
Time Frame
Up to approximately 156 weeks
Title
Part 1: Maximum observed plasma concentration (Cmax)
Description
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Time Frame
Day 7
Title
Part 1: Time to maximum observed plasma concentration (Tmax)
Description
Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
Time Frame
Day 7
Title
Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)
Description
The area under the plasma concentration-time curve is a method of measurement of the total exposure of a drug in plasma.
Time Frame
Day 7
Title
Part 1: Apparent oral clearance at steady state (CL/F)
Description
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Time Frame
Day 7
Title
Part 1: Half-life
Description
Half life of updadacitinib will be determined using non-compartmental method.
Time Frame
Day 7
10. Eligibility
Sex
All
Minimum Age & Unit of Time
2 Years
Maximum Age & Unit of Time
17 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
ABBVIE CALL CENTER
Phone
844-663-3742
Email
abbvieclinicaltrials@abbvie.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
ABBVIE INC.
Organizational Affiliation
AbbVie
Official's Role
Study Director
Facility Information:
Facility Name
Ann & Robert H Lurie Children's Hospital of Chicago /ID# 211162
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
University of Louisville /ID# 202896
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Individual Site Status
Completed
Facility Name
Boston Children's Hospital /ID# 202993
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
Individual Site Status
Completed
Facility Name
Cincinnati Childrens Hospital Medical Center /ID# 209697
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45229
Country
United States
Individual Site Status
Recruiting
Facility Name
Randall Children's Hospital /ID# 213609
City
Portland
State/Province
Oregon
ZIP/Postal Code
97227-1654
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Site Coordinator
Phone
844-663-3742
Facility Name
Children's Hospital of Philadelphia /ID# 209617
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19146-2305
Country
United States
Individual Site Status
Recruiting
Facility Name
Children's Hospital of Pittsburgh of UPMC /ID# 202994
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15224-1334
Country
United States
Individual Site Status
Completed
Facility Name
Seattle Children's Hospital /ID# 203003
City
Seattle
State/Province
Washington
ZIP/Postal Code
98105
Country
United States
Individual Site Status
Recruiting
Facility Name
St. Josef-Stift Sendenhorst /ID# 244740
City
Sendenhorst
State/Province
Nordrhein-Westfalen
ZIP/Postal Code
48324
Country
Germany
Individual Site Status
Recruiting
Facility Name
PRI - Pediatric Rheumatology Research Institute /ID# 205954
City
Bad Bramstedt
ZIP/Postal Code
24576
Country
Germany
Individual Site Status
Completed
Facility Name
Helios Klinikum Berlin-Buch /ID# 206859
City
Berlin
ZIP/Postal Code
13125
Country
Germany
Individual Site Status
Completed
Facility Name
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
City
Hamburg
ZIP/Postal Code
22081
Country
Germany
Individual Site Status
Recruiting
Facility Name
Asklepios Klinik Sankt Augustin /ID# 203264
City
Sankt Augustin
ZIP/Postal Code
53757
Country
Germany
Individual Site Status
Recruiting
Facility Name
Semmelweis Egyetem /ID# 208970
City
Budapest
ZIP/Postal Code
1085
Country
Hungary
Individual Site Status
Recruiting
Facility Name
The Chaim Sheba Medical Center /ID# 222370
City
Ramat Gan
State/Province
Tel-Aviv
ZIP/Postal Code
5265601
Country
Israel
Individual Site Status
Recruiting
Facility Name
IRCCS Ospedale Pediatrico Bambino Gesu /ID# 203835
City
Rome
State/Province
Lazio
ZIP/Postal Code
00165
Country
Italy
Individual Site Status
Recruiting
Facility Name
Aichi Children's Health and Medical Center /ID# 248327
City
Obu-shi
State/Province
Aichi
ZIP/Postal Code
474-8710
Country
Japan
Individual Site Status
Recruiting
Facility Name
Hyogo Prefectural Kobe Children's Hospital /ID# 246582
City
Kobe-shi
State/Province
Hyogo
ZIP/Postal Code
650-0047
Country
Japan
Individual Site Status
Recruiting
Facility Name
Kagoshima University Hospital /ID# 246501
City
Kagoshima-shi
State/Province
Kagoshima
ZIP/Postal Code
890-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
St. Marianna University Hospital /ID# 246478
City
Kawasaki-shi
State/Province
Kanagawa
ZIP/Postal Code
216-8511
Country
Japan
Individual Site Status
Recruiting
Facility Name
Miyagi Children's Hospital /ID# 246734
City
Sendai-shi
State/Province
Miyagi
ZIP/Postal Code
989-3126
Country
Japan
Individual Site Status
Recruiting
Facility Name
Niigata University Medical & Dental Hospital /ID# 247246
City
Niigata-shi
State/Province
Niigata
ZIP/Postal Code
951-8520
Country
Japan
Individual Site Status
Recruiting
Facility Name
Tokyo Medical And Dental University Hospital /ID# 246500
City
Bunkyo-ku
State/Province
Tokyo
ZIP/Postal Code
113-8519
Country
Japan
Individual Site Status
Recruiting
Facility Name
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
City
Bayamon
ZIP/Postal Code
00959
Country
Puerto Rico
Individual Site Status
Completed
Facility Name
GCM Medical Group PSC /ID# 211702
City
San Juan
ZIP/Postal Code
00917-3104
Country
Puerto Rico
Individual Site Status
Recruiting
Facility Name
Mindful Medical Research /ID# 204488
City
San Juan
ZIP/Postal Code
00918-3756
Country
Puerto Rico
Individual Site Status
Completed
Facility Name
Hospital Sant Joan de Deu /ID# 203915
City
Esplugues de Llobregat
State/Province
Barcelona
ZIP/Postal Code
08950
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Infantil Universitario Nino Jesus /ID# 206466
City
Madrid
ZIP/Postal Code
28009
Country
Spain
Individual Site Status
Completed
Facility Name
Hospital Universitario Ramon y Cajal /ID# 203917
City
Madrid
ZIP/Postal Code
28034
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario La Paz /ID# 203927
City
Madrid
ZIP/Postal Code
28046
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hospital Universitario y Politecnico La Fe /ID# 203914
City
Valencia
ZIP/Postal Code
46026
Country
Spain
Individual Site Status
Recruiting
Facility Name
Queen Silvia Children's Hosp /ID# 251145
City
Gothenburg
State/Province
Vastra Gotalands Lan
ZIP/Postal Code
416 85
Country
Sweden
Individual Site Status
Recruiting
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
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