Upadacitinib for Juvenile Arthritis

(SELECT-YOUTH Trial)

Not currently recruiting at 48 trial locations

Overseen By ABBVIE CALL CENTER

Age: < 18

Sex: Any

Trial Phase: Phase 1

Sponsor: AbbVie

Must be taking: Methotrexate, Glucocorticosteroids

Must not be taking: JAK inhibitors

Disqualifiers: Enthesitis-related arthritis, Juvenile psoriatic arthritis

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 7 days

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and tolerability of upadacitinib, a medication for juvenile arthritis, in children with a type of juvenile arthritis affecting multiple joints. Researchers are examining the drug's behavior in the body and its long-term effects. The study consists of several parts, with different doses for children based on age and weight. Eligible participants have arthritis affecting five or more joints and are currently managing it with medications such as methotrexate or low-dose steroids. As a Phase 1 trial, participants will be among the first to receive this new treatment, aiding researchers in understanding its effects in people.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop all current medications, but if you are taking methotrexate or oral glucocorticosteroids, you must continue them at a stable dose. There is no mention of a washout period for other medications.

Is there any evidence suggesting that this trial's treatment is likely to be safe?

Research shows that upadacitinib is generally safe for children with juvenile idiopathic arthritis. Studies have found that adjusting the dose based on a child's weight is effective and safe. Other studies report common side effects, such as mild to moderate headaches or stomach upset. Upadacitinib has already received approval for some adult conditions, providing insight into its safety. However, as this is an early-phase study, researchers will closely monitor safety in younger children. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for juvenile arthritis?

Researchers are excited about upadacitinib for juvenile arthritis because it offers a unique approach compared to existing treatments. Most current options, like methotrexate or biologics, focus on reducing inflammation through different pathways. However, upadacitinib is a JAK inhibitor, which means it specifically targets enzymes known as Janus kinases involved in the inflammation process. By blocking these enzymes, upadacitinib can potentially offer more precise control of the disease with fewer side effects. This targeted action could lead to better management of arthritis symptoms in young patients, providing relief faster and more effectively than some traditional therapies.

What evidence suggests that upadacitinib might be an effective treatment for juvenile arthritis?

Research has shown that upadacitinib may help treat juvenile idiopathic arthritis (JIA). Studies suggest it works in children similarly to its effects in adults with rheumatoid or psoriatic arthritis. An early review found that upadacitinib was effective and well-tolerated in children with polyarticular juvenile idiopathic arthritis (pcJIA) when dosed according to weight. This trial will evaluate upadacitinib in different dosage arms for children aged two and older with certain types of JIA. These findings support the potential benefits of upadacitinib for young patients with these conditions. ^{3 4 5 6 7}

Who Is on the Research Team?

ABBVIE INC.

Principal Investigator

AbbVie

Are You a Good Fit for This Trial?

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.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Multiple-cohort study with two sequential multiple dose groups to evaluate pharmacokinetics, safety, and tolerability

7 days

Daily visits for pharmacokinetic assessments

Open-label extension

Participants benefiting from the study drug with no ongoing adverse events can enroll in a long-term extension to evaluate safety and tolerability

Up to approximately 156 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Upadacitinib

Trial Overview 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.

How Is the Trial Designed?

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

Who Is Running the Clinical Trial?

AbbVie

Lead Sponsor

Trials

1,079

Recruited

535,000+

Founded

2013

Headquarters

North Chicago, USA

Known For

Immunology treatments

Top Products

Humira (adalimumab), Skyrizi (risankizumab), Rinvoq (upadacitinib)

Dr. Roopal Thakkar

AbbVie

Chief Medical Officer since 2023

MD from Wayne State University School of Medicine

Robert A. Michael

AbbVie

Chief Executive Officer

Bachelor's degree in Finance from the University of Illinois

Published Research Related to This Trial

Upadacitinib, an oral JAK-1 inhibitor, received marketing approval in the USA in August 2019 for treating moderately to severely active rheumatoid arthritis after showing positive results in multinational phase III trials.

The approval was specifically for patients who had an inadequate response or intolerance to methotrexate, highlighting its role as an effective alternative treatment option.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib: First Approval. Duggan, S., Keam, SJ.[2020]

In a study involving 661 patients with rheumatoid arthritis (RA) who did not respond adequately to conventional DMARDs, upadacitinib (15 mg and 30 mg) significantly improved patient-reported outcomes such as pain, physical function, and overall disease activity after 12 weeks compared to placebo.

Patients taking upadacitinib reported clinically meaningful improvements in various measures, with the number needed to treat (NNT) for these benefits ranging from 4 to 8, indicating that a small number of patients need to be treated for one to experience significant improvement.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Upadacitinib improves patient-reported outcomes in patients with rheumatoid arthritis and inadequate response to conventional synthetic disease-modifying antirheumatic drugs: results from SELECT-NEXT. Strand, V., Pope, J., Tundia, N., et al.[2021]

Citations

1. ascpt.onlinelibrary.wiley.com ascpt.onlinelibrary.wiley.com/doi/full/10.1002/cpt.3441

Extrapolation of Upadacitinib Efficacy in Juvenile Idiopathic ... Simulations demonstrate that upadacitinib efficacy in pcJIA and JPsA is predicted to be non-inferior to that in adults with RA or PsA, respectively.

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC12038220/

Pharmacokinetics, Efficacy, and Safety of Upadacitinib in ... This interim analysis demonstrates that the bodyweight‐based dosing regimen of upadacitinib was well tolerated and efficacious in pediatric patients with pcJIA.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT05609630

NCT05609630 | Study of Oral Upadacitinib and ... This study will assess how safe and effective upadacitinib is in treating pediatric and adolescent participants aged 1 to < 18 with systemic juvenile idiopathic ...

4. rinvoqhcp.com rinvoqhcp.com/content/dam/rinvoqhcpivy/docs/digital-rheum-pediatric-core-leave-behind-sp.pdf

Polyarticular Juvenile Idiopathic Arthritis Safety and efficacy of upadacitinib in patients with rheumatoid arthritis and inadequate response or intolerance to biologic treatments: results through 5 years ...

5. news.abbvie.com news.abbvie.com/2024-06-04-RINVOQ-R-upadacitinib-Now-Available-for-Pediatric-Patients-Two-Years-and-Older-with-Polyarticular-Juvenile-Idiopathic-Arthritis-and-Psoriatic-Arthritis

RINVOQ® (upadacitinib) Now Available for Pediatric ... Long-Term Outcomes in Juvenile Idiopathic Arthritis: Eighteen Years of Follow-Up in the Population-Based Nordic Juvenile Idiopathic Arthritis ...

6. clinicaltrials.gov clinicaltrials.gov/study/NCT03725007

NCT03725007 | A Study to Evaluate the Pharmacokinetics, ... This is a study to evaluate pharmacokinetics, safety and tolerability of upadacitinib in pediatric participants with polyarticular course juvenile idiopathic ...

7. rinvoqhcp.com rinvoqhcp.com/dermatology/safety

RINVOQ® (upadacitinib) Safety Data Discover RINVOQ® (upadacitinib) safety considerations, study designs, and common adverse events. See full Prescribing Information and Important Safety ...