Juvenile Idiopathic Arthritis (JIA)Phase 1SELECT-YOUTHNCT03725007
A Study to Evaluate the Pharmacokinetics, Safety, and Tolerability of Upadacitinib in Pediatric Subjects With Polyarticular Course Juvenile Idiopathic Arthritis
A Phase 1 study testing Upadacitinib in people with Juvenile Idiopathic Arthritis (JIA), run by AbbVie at 35 sites in 10 countries.
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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Juvenile Idiopathic Arthritis (JIA)
- What is being tested?
- Upadacitinib
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 124 participants
- Where
- 35 sitesin 10 countries
- Study dates
- 24 Jun 2019to Mar 2029
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
- Participant have prior exposure to JAK inhibitor.
Trial locations and contacts
35 sites in 10 countries.
35 sites in 10 countries
United States8 sites
Boston Children's Hospital /ID# 202993
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago /ID# 211162
Chicago, Illinois, 60611
Cincinnati Childrens Hospital Medical Center /ID# 209697
Cincinnati, Ohio, 45229
Duplicate_University of Louisville /ID# 202896
Louisville, Kentucky, 40202
The Children's Hospital of Philadelphia /ID# 209617
Philadelphia, Pennsylvania, 19104
Children's Hospital of Pittsburgh of UPMC /ID# 202994
Pittsburgh, Pennsylvania, 15224-1334
Randall Children's Hospital /ID# 213609
Portland, Oregon, 97227-1654
Seattle Children's Hospital /ID# 203003
Seattle, Washington, 98105
Japan7 sites
Institute of Science Tokyo Hospital /ID# 246500
Bunkyo-ku, Tokyo, 113-8519
Kagoshima University Hospital /ID# 246501
Kagoshima, Kagoshima-ken, 890-8520
St Marianna University School Of Medicine /ID# 246478
Kawasaki-shi, Kanagawa, 216-8511
Hyogo Prefectural Kobe Children'S Hospital - Minatojima /ID# 246582
Kobe, Hyōgo, 650-0045
Niigata University Medical and Dental Hospital /ID# 247246
Niigata, Niigata, 951-8520
Aichi Children's Health and Medical Center /ID# 248327
Obu-shi, Aichi-ken, 474-8710
Miyagi Children's Hospital /ID# 246734
Sendai, Miyagi, 989-3126
Germany5 sites
PRI - Pediatric Rheumatology Research Institute /ID# 205954
Bad Bramstedt, Schleswig-Holstein, 24576
Helios Klinikum Berlin-Buch /ID# 206859
Berlin, 13125
Hamburger Zentrum fuer Kinder- und Jugendrheumatologie /ID# 206571
Hamburg, 22081
Asklepios Klinik Sankt Augustin /ID# 203264
Sankt Augustin, North Rhine-Westphalia, 53757
St. Josef-Stift Sendenhorst /ID# 244740
Sendenhorst, North Rhine-Westphalia, 48324
Spain5 sites
Hospital Sant Joan de Deu /ID# 203915
Esplugues de Llobregat, Barcelona, 08950
Hospital Infantil Universitario Nino Jesus /ID# 206466
Madrid, 28009
Hospital Universitario Ramon y Cajal /ID# 203917
Madrid, 28034
Hospital Universitario La Paz /ID# 203927
Madrid, 28046
Hospital Universitario y Politecnico La Fe /ID# 203914
Valencia, 46026
Canada3 sites
Alberta Children's Hospital /ID# 251738
Calgary, Alberta, T3B 6A8
Duplicate_McGill University Health Centre /ID# 251252
Montreal, Quebec, H4A 3J1
British Columbia Children and Women's Hospital and Health Centre /ID# 251736
Vancouver, British Columbia, V6H 3N1
Puerto Rico3 sites
Centro de Reumatologia Pediatrico de Puerto Rico /Id# 204406
Bayamón, 00959
GCM Medical Group /ID# 211702
San Juan, 00917-3104
Mindful Medical Research /ID# 204488
San Juan, 00918-3756
Israel1 site
The Chaim Sheba Medical Center /ID# 222370
Ramat Gan, Tel Aviv, 5265601
Sweden1 site
Queen Silvia Children's Hosp /ID# 251145
Gothenburg, Västra Götaland County, 416 85
About this study
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
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. Participants <18 years of age who are ongoing in Parts 2 and 3 will participate in an 104 week open-label extension of the study in Part 4.
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Being tested
- Upadacitinib
- Keywords
- Upadacitinib, ABT-494, Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
- Medical subject headings
- Arthritis, Juvenile
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
UpadacitinibDrug
Also called ABT-494
Upadacitinib is administered as an oral solution or tablet as described in protocol.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: 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. Receives: 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. Receives: 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. Receives: Drug: Upadacitinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Up to approximately 260 weeks
Part 1: Maximum observed plasma concentration (Cmax)
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Measured: Day 7
Part 1: Time to maximum observed plasma concentration (Tmax)
Tmax is defined as the time to maximum plasma concentration (Cmax) of upadacitinib.
Measured: 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.
Measured: 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.
Measured: Day 7
Part 1: Half-life
Half life of updadacitinib will be determined using non-compartmental method.
Measured: Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2018
- Study start24 Jun 2019
- Primary completionDec 2028 (estimated)
- Study completionMar 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Juvenile Idiopathic Arthritis (JIA)Studies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Enrolment
- 124 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03725007
- Sponsor's protocol ID
- M15-340
- Other IDs
- 2023-505060-11-00, 2023
- Acronym
- SELECT-YOUTH
- Status last verified
- Jul 2026
- First submitted
- 27 Oct 2018
- Last updated
- 3 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT03725007
- Acronym / sponsor ID
- SELECT-YOUTH / M15-340
- Conditions
- Juvenile Idiopathic Arthritis (JIA)
- Keywords
- Upadacitinib, ABT-494, Polyarticular Course Juvenile Idiopathic Arthritis (pcJIA)
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 124 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 24 Jun 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Mar 2029 (estimated)
- First posted
- 30 Oct 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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. Participants <18 years of age who are ongoing in Parts 2 and 3 will participate in an 104 week open-label extension of the study in Part 4.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Participants of age group 12 to <18 years receiving dose A | Experimental | Drug: UpadacitinibParticipants 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 receiving dose B | Experimental | Drug: UpadacitinibParticipants 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 receiving dose A | Experimental | Drug: UpadacitinibParticipants 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 receiving dose A | Experimental | Drug: UpadacitinibParticipants 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 receiving dose A | Experimental | Drug: UpadacitinibParticipants of age group 2 to <18 years administered with upadacitinib dose A as described in the protocol. |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (2 listed)
- Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).
- Participant have prior exposure to JAK inhibitor.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| UpadacitinibAlso: ABT-494Upadacitinib is administered as an oral solution or tablet as described in protocol. | Drug | 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 |
Primary outcome
Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 260 weeks
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)
Time frame: Day 7
Cmax is defined as the maximum observed plasma concentration for upadacitinib.
Part 1: Time to maximum observed plasma concentration (Tmax)
Time frame: Day 7
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)
Time frame: Day 7
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)
Time frame: Day 7
Clearance is defined as the volume of plasma cleared of the drug per unit time.
Part 1: Half-life
Time frame: Day 7
Half life of updadacitinib will be determined using non-compartmental method.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
35 sites in 10 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Upadacitinib in people with Juvenile Idiopathic Arthritis (JIA), run by AbbVie at 35 sites in 10 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 3 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 35 sites in United States, Japan, Germany, Spain, Canada and 5 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment Emergent Adverse Events (TEAEs) (time frame: Up to approximately 260 weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Aug 2026; AzTrials last refreshed its copy on 26 Oct 2026.