Upadacitinib for Juvenile Arthritis

(SELECT-YOUTH Trial)

Recruiting at 39 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

122 Participants Needed

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.

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.

What data supports the effectiveness of the drug Upadacitinib for treating juvenile arthritis?

Upadacitinib has shown effectiveness in treating rheumatoid arthritis, a condition similar to juvenile arthritis, by reducing joint damage and improving patient-reported outcomes. It works by inhibiting Janus kinase 1 (JAK-1), which plays a role in inflammation, and has been approved for use in rheumatoid arthritis after successful trials. ^{1 2 3 4 5}

How is the drug Upadacitinib different from other treatments for juvenile arthritis?

Upadacitinib is unique because it is an oral medication that selectively inhibits Janus kinase (JAK), a protein involved in inflammation, which is different from many other treatments that target different pathways or require injections. It has shown effectiveness in rheumatoid arthritis, suggesting potential benefits for juvenile arthritis, especially for patients who do not respond well to other treatments. ^{2 3 6 7 8}

Research Team

ABBVIE INC.

Principal Investigator

AbbVie

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.

Timeline

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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]

References

1. England pubmed.ncbi.nlm.nih.gov

Baricitinib in juvenile idiopathic arthritis: an international, phase 3, randomised, double-blind, placebo-controlled, withdrawal, efficacy, and safety trial. [2023]

2. England pubmed.ncbi.nlm.nih.gov

Inhibition of structural joint damage progression with upadacitinib in rheumatoid arthritis: 1-year outcomes from the SELECT phase 3 program. [2022]

3. Spain pubmed.ncbi.nlm.nih.gov

Upadacitinib tartrate in rheumatoid arthritis. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Upadacitinib: First Approval. [2020]

5. England 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. [2021]

6. United States pubmed.ncbi.nlm.nih.gov

Trial of Upadacitinib or Abatacept in Rheumatoid Arthritis. [2021]

7. England pubmed.ncbi.nlm.nih.gov

A Matching-Adjusted Indirect Comparison of Upadacitinib Versus Tofacitinib in Adults with Moderate-to-Severe Rheumatoid Arthritis. [2021]

8. New Zealand pubmed.ncbi.nlm.nih.gov

The Safety Profile of Upadacitinib in Patients with Rheumatoid Arthritis in Japan. [2022]