What side effects are associated with this type of intervention?

Common treatments for atopic dermatitis, particularly Janus kinase (JAK) inhibitors like upadacitinib, have several known side effects. These include acne, upper respiratory infections, nasopharyngitis, headache, and elevation of creatine phosphokinase. Additionally, there can be a worsening of atopic dermatitis symptoms. Other adverse events reported with JAK inhibitors include conjunctivitis and application site pruritis when used topically.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including dupilumab, a monoclonal antibody targeting the IL-4 receptor, and various topical corticosteroids. Similar to upadacitinib, which is a JAK inhibitor, other JAK inhibitors like tofacitinib and ruxolitinib have been studied for their efficacy in treating atopic dermatitis. These treatments work by modulating the immune response to reduce inflammation and alleviate symptoms.

What other types of research exist?

Promising novel alternatives to Upadacitinib for Atopic Dermatitis patients include Delgocitinib, a topical JAK inhibitor, and Omalizumab, an anti-IgE monoclonal antibody. Both have shown efficacy in treating AD and offer different mechanisms of action compared to Upadacitinib.

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Janus Kinase (JAK) Inhibitor

Upadacitinib for Pediatric Eczema

Q: What is the mechanism of action of this treatment?

Janus kinase (JAK) inhibitors, such as upadacitinib, work by blocking the JAK-STAT signaling pathway, which is involved in the inflammatory process of atopic dermatitis. By inhibiting this pathway, JAK inhibitors reduce inflammation and immune responses that contribute to the symptoms of AD. Dupilumab, another common treatment, is a monoclonal antibody that targets the IL-4 and IL-13 pathways, which are also key drivers of inflammation in AD. Topical corticosteroids reduce inflammation and immune activity by suppressing various inflammatory cytokines. These treatments are crucial for AD patients as they help manage severe symptoms, reduce flare-ups, and improve quality of life by targeting the underlying inflammatory mechanisms of the disease.

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

Meets Hanifin and Rajka criteria for AD.

Diagnosed with active severe AD defined by Eczema Area Severity Index (EASI), Validated Investigator's Global Assessment (IGA) and body surface area (BSA).

Must not have

Prior exposure to Janus Kinase (JAK) inhibitor.

Current use of known moderate or strong inhibitors or inducers of drug metabolizing enzymes within 30 days prior to the first dose of study drug and through the end of Part 1 of the study.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing upadacitinib, a medication taken by mouth, to see if it is safe and well-tolerated in children with severe eczema. The study aims to understand how the drug behaves in the body and if children can take it without issues. Upadacitinib works by reducing inflammation and calming the immune system's overreaction, which can help improve eczema symptoms.

Who is the study for?

This trial is for children with severe atopic dermatitis (eczema) who've had symptoms for at least 6 months. They must weigh over 10 kg and be aged 3 or older, have tried treatments like topical steroids without success, and meet specific criteria for AD severity. Kids who've used JAK inhibitors or certain other drugs recently can't participate.

What is being tested?

The study tests multiple doses of Upadacitinib in kids with severe eczema to see how safe it is, how the body processes it, and if the oral solution tastes okay. It's about finding out if this medication could help manage their skin condition effectively.

What are the potential side effects?

While not specified here, common side effects of medications like Upadacitinib may include infections, headaches, nausea, and potential changes in blood test results. The exact side effects will be monitored closely throughout the trial.

Eligibility Criteria

Inclusion Criteria

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

Select...

I have been diagnosed with atopic dermatitis according to Hanifin and Rajka's criteria.

Select...

I have severe eczema as diagnosed by a doctor.

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 haven't taken strong medication that affects drug metabolism in the last 30 days.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 2 years for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Area under the plasma concentration-time curve within a dosing interval (AUCtau)

Maximum Plasma Concentration (Cmax)

Number of Participants With Treatment Emergent Adverse Events (TEAE)

+2 more

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: Part 2Experimental Treatment1 Intervention

Eligible participants who completed Part 1 will receive weight-dependant low dose of upadacitinib.

Group II: Part 1; Cohort 4Experimental Treatment1 Intervention

Participants, 2 to \<6 years of age, will receive high dose of upadacitinib.

Group III: Part 1; Cohort 3Experimental Treatment1 Intervention

Participants, 2 to \<6 years of age, will receive low dose of upadacitinib.

Group IV: Part 1; Cohort 2Experimental Treatment1 Intervention

Participants, 6 to \<12 years of age, will receive high dose of upadacitinib.

Group V: Part 1; Cohort 1Experimental Treatment1 Intervention

Participants, 6 to \<12 years of age, will receive low dose of upadacitinib.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib (ABT-494)

2019

Completed Phase 1

~40

0 / 4Eligibility 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 JAK-STAT signaling pathway, which is involved in the inflammatory process of atopic dermatitis. By inhibiting this pathway, JAK inhibitors reduce inflammation and immune responses that contribute to the symptoms of AD. Dupilumab, another common treatment, is a monoclonal antibody that targets the IL-4 and IL-13 pathways, which are also key drivers of inflammation in AD. Topical corticosteroids reduce inflammation and immune activity by suppressing various inflammatory cytokines. These treatments are crucial for AD patients as they help manage severe symptoms, reduce flare-ups, and improve quality of life by targeting the underlying inflammatory mechanisms of the disease.