What is the mechanism of action of this treatment?

Janus Kinase (JAK) inhibitors, such as Upadacitinib, work by blocking the activity of enzymes in the JAK family, which are crucial in the signaling pathways that lead to inflammation. By inhibiting these enzymes, JAK inhibitors reduce the production of inflammatory cytokines, thereby decreasing inflammation and immune response. This mechanism is vital for Juvenile Idiopathic Arthritis (JIA) patients as it helps control symptoms like joint pain, swelling, and stiffness, and can prevent long-term joint damage. Other common treatments for JIA include methotrexate, which reduces cell proliferation, and biologics like TNF inhibitors, which block inflammatory pathways.

What side effects are associated with this type of intervention?

Common treatments for Juvenile Idiopathic Arthritis (JIA) include nonsteroidal anti-inflammatory drugs (NSAIDs), methotrexate, and biologic agents such as TNF inhibitors and JAK inhibitors like Upadacitinib. NSAIDs can cause gastrointestinal issues, renal problems, and cardiovascular effects. Methotrexate is associated with liver toxicity, bone marrow suppression, and gastrointestinal disturbances. Biologic agents, including TNF inhibitors, can increase the risk of infections, injection site reactions, and potential malignancies. JAK inhibitors, such as Upadacitinib, may cause venous thrombosis, pulmonary embolism, infections including tuberculosis, and malignancies.

What prior FDA approvals exist?

The FDA has approved several treatments for Juvenile Idiopathic Arthritis (JIA), including biologic and non-biologic disease-modifying antirheumatic drugs (DMARDs). Similar to Upadacitinib, Tofacitinib is another JAK inhibitor that has been approved for JIA. Additionally, biologic agents such as Etanercept, Adalimumab, and Abatacept have been approved for treating various forms of JIA. These treatments aim to reduce inflammation and improve symptoms in children with JIA.

What other types of research exist?

Promising alternatives to Upadacitinib for JIA patients include: 1) Abatacept, a T-cell modulator, which has shown efficacy in clinical trials for JIA. 2) Methotrexate in combination with prednisone, which has demonstrated improved outcomes compared to prednisone alone. 3) Biologic agents such as Etanercept and Adalimumab, which are TNF inhibitors with established efficacy in pediatric rheumatology. 4) Ustekinumab, an IL-12/23 inhibitor, which has shown positive results in psoriatic arthritis and may be considered for JIA.

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Janus Kinase (JAK) Inhibitor

Upadacitinib for Juvenile Arthritis (SELECT-YOUTH Trial)

Phase 1

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Participant have total body weight of 10 kg or higher at the time of screening.

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.

Must not have

Participant have prior exposure to JAK inhibitor.

Participant with diagnosis of enthesitis-related arthritis (ERA) or juvenile psoriatic arthritis (JPSA).

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to approximately 156 weeks

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects are not listed here, typically such trials look out for any adverse reactions related to the medication being tested which could include gastrointestinal issues, skin reactions, changes in blood counts or liver enzymes among others.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I weigh at least 10 kg.

Select...

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

Select...

I have 5 or more joints with swelling, pain, or limited movement.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I have been treated with a JAK inhibitor before.

Select...

I have been diagnosed with ERA or JPSA.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to approximately 156 weeks

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to approximately 156 weeks

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to approximately 156 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Part 1: Apparent oral clearance at steady state (CL/F)

Part 1: Area under plasma concentration versus time curve during a dosing interval (AUCtau)

Part 1: Half-life

+3 more

Side effects data

From 2023 Phase 3 trial • 657 Patients • NCT03086343

24%

UPPER RESPIRATORY TRACT INFECTION

24%

HYPERTENSION

18%

BRONCHITIS

12%

ACUTE RESPIRATORY FAILURE

12%

RASH

12%

URINARY TRACT INFECTION

12%

INFLUENZA

12%

FALL

12%

ARTHRALGIA

12%

WEIGHT INCREASED

12%

SINUSITIS

12%

MUSCLE SPASMS

12%

CHOLELITHIASIS

12%

NASOPHARYNGITIS

12%

LIVER FUNCTION TEST INCREASED

12%

OROPHARYNGEAL PAIN

DEHYDRATION

PNEUMONIA BACTERIAL

HEPATIC STEATOSIS

ASTHMA

NASAL CONGESTION

PULMONARY EMBOLISM

HYPONATRAEMIA

CONSTIPATION

RHINORRHOEA

BLOOD PRESSURE INCREASED

COUGH

BONE CONTUSION

HIP FRACTURE

VOMITING

PERIPHERAL SWELLING

STAPHYLOCOCCAL INFECTION

ORAL CANDIDIASIS

PNEUMONIA

FEELING HOT

HEADACHE

HAEMOGLOBIN DECREASED

COSTOCHONDRITIS

RHEUMATOID ARTHRITIS

PARAESTHESIA

PHOTODERMATOSIS

LEUKOCYTOSIS

TACHYCARDIA

HYPOKALAEMIA

STOMATITIS

PATELLA FRACTURE

ACTINIC KERATOSIS

GLAUCOMA

BACTERIAL SEPSIS

CHEST PAIN

FATIGUE

ATRIOVENTRICULAR BLOCK FIRST DEGREE

CANDIDA INFECTION

COVID-19

CATARACT

INFECTIOUS PLEURAL EFFUSION

SJOGREN'S SYNDROME

DYSPHAGIA

SWELLING

ACUTE KIDNEY INJURY

HERPES ZOSTER

OSTEOARTHRITIS

NAUSEA

NON-CARDIAC CHEST PAIN

RHINITIS

BLOOD CREATINE PHOSPHOKINASE INCREASED

FEMUR FRACTURE

LIGAMENT RUPTURE

SKIN LACERATION

SUPRAVENTRICULAR TACHYCARDIA

SCRATCH

SEBORRHOEIC KERATOSIS

EYE HAEMATOMA

INSOMNIA

ERYTHEMA

PRURITUS

DERMATITIS ALLERGIC

BACK PAIN

DIZZINESS

FLANK PAIN

SCIATICA

ANAEMIA

BILIARY COLIC

DERMATITIS CONTACT

DRUG HYPERSENSITIVITY

HERPES SIMPLEX

LOCALISED INFECTION

VULVOVAGINAL MYCOTIC INFECTION

DIABETES MELLITUS

VITAMIN D DEFICIENCY

CHRONIC OBSTRUCTIVE PULMONARY DISEASE

OSTEOPENIA

PHARYNGITIS

100%

80%

60%

40%

20%

Study treatment Arm

Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD

Period 2, Primary Cohort: Upadacitinib 15 mg QD/Upadacitinib 15 mg QD

Period 2, Primary Cohort: Abatacept/Upadacitinib 15 mg QD

Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD

Period 1, 30 mg Cohort: Upadacitinib 30 mg QD

Period 2, 30 mg Cohort: Abatacept/Upadacitinib 30 mg QD

Period 2, 30 mg Cohort: Upadacitinib 30 mg QD/Upadacitinib 30 mg QD/Upadacitinib 15 mg QD

Period 1, Primary and 30 mg Cohorts: Abatacept

Period 1, Primary Cohort: Upadacitinib 15 mg QD

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

5Treatment groups

Experimental Treatment

Group I: Participants of age group 6 to <12 years receiving dose AExperimental Treatment1 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 AExperimental Treatment1 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 AExperimental Treatment1 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 BExperimental Treatment1 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 AExperimental Treatment1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~11250

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Janus Kinase (JAK) inhibitors, such as Upadacitinib, work by blocking the activity of enzymes in the JAK family, which are crucial in the signaling pathways that lead to inflammation. By inhibiting these enzymes, JAK inhibitors reduce the production of inflammatory cytokines, thereby decreasing inflammation and immune response. This mechanism is vital for Juvenile Idiopathic Arthritis (JIA) patients as it helps control symptoms like joint pain, swelling, and stiffness, and can prevent long-term joint damage. Other common treatments for JIA include methotrexate, which reduces cell proliferation, and biologics like TNF inhibitors, which block inflammatory pathways.