Upadacitinib for Juvenile Arthritis

(SELECT-YOUTH Trial)

Recruiting in Palo Alto (17 mi)

+39 other locations

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 1

Waitlist Available

Sponsor: AbbVie

No Placebo Group

Approved in 3 Jurisdictions

Trial Summary

What is the purpose of this trial?

This trial is testing a medication called upadacitinib in children with a type of arthritis that affects many joints. The study aims to see how the drug behaves in their bodies, how safe it is, and how well they can tolerate it. Upadacitinib works by reducing inflammation and pain by blocking certain enzymes in the body. It has been approved for treating rheumatoid arthritis in adults.

Eligibility Criteria

This trial is for children with polyarticular course juvenile idiopathic arthritis (pcJIA) who have at least 5 active joints and weigh over 10 kg. They must have been diagnosed with pcJIA, possibly taking methotrexate for 12 weeks or more, and if on steroids, they should be on a stable dose. Kids with enthesitis-related arthritis or juvenile psoriatic arthritis, or those previously treated with JAK inhibitors can't participate.

Inclusion Criteria

I weigh at least 10 kg.

I have been on a stable dose of methotrexate for at least 8 weeks and take folic or folinic acid.

I have been on a stable dose of oral glucocorticosteroids for at least a week.

Exclusion Criteria

I have been treated with a JAK inhibitor before.

I have been diagnosed with ERA or JPSA.

Participant Groups

The study tests Upadacitinib's effects in kids with pcJIA across three parts: initial multiple-dose groups, an open-label extension to assess long-term safety/tolerability, and an additional cohort for further safety evaluation. The goal is to understand how the drug works in young bodies and monitor its ongoing safety.

Group I: Participants of age group 6 to <12 years receiving dose A Experimental Treatment 1 Intervention

Participants of age group 6 to \<12 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Group II: Participants of age group 2 to <6 years receiving dose A Experimental Treatment 1 Intervention

Participants of age group 2 to \<6 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Group III: Participants of age group 2 to <18 years receiving dose A Experimental Treatment 1 Intervention

Participants of age group 2 to \<18 years administered with upadacitinib dose A as described in the protocol.

Group IV: Participants of age group 12 to <18 years receiving dose B Experimental Treatment 1 Intervention

Participants of age group 12 to \<18 years administered with upadacitinib dose B (weight dependent) as described in the protocol.

Group V: Participants of age group 12 to <18 years receiving dose A Experimental Treatment 1 Intervention

Participants of age group 12 to \<18 years administered with upadacitinib dose A (weight dependent) as described in the protocol.

Upadacitinib is already approved in European Union, United States, Canada for the following indications:

🇪🇺 Approved in European Union as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

🇺🇸 Approved in United States as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis
• Ulcerative colitis
• Crohn's disease

🇨🇦 Approved in Canada as Rinvoq for:

• Rheumatoid arthritis
• Psoriatic arthritis
• Atopic dermatitis
• Ankylosing spondylitis

Find a Clinic Near You

Research Locations Nearby Select from list below to view details:

Boston Childrens Hospital /ID# 202993 Boston, MA

Cincinnati Childrens Hosp Med /ID# 209697 Cincinnati, OH

Duplicate_University of Louisville /ID# 202896 Louisville, KY

British Columbia Children and Women's Hospital and Health Centre /ID# 251736 Vancouver, Canada

More Trial Locations

Who Is Running the Clinical Trial?

AbbVie Lead Sponsor

References