What side effects are associated with this type of intervention?

Upadacitinib, a JAK1 inhibitor, is associated with side effects such as acne, upper respiratory infections, nasopharyngitis, headache, elevated creatine phosphokinase, and worsening of atopic dermatitis. Dupilumab, an IL-4 and IL-13 inhibitor, commonly causes injection site reactions, conjunctivitis, facial redness, and can lead to the development of antibodies against the drug. Other adverse events include eosinophilia, herpes simplex virus infection, joint pain, and a psoriasis-like eruption. Both treatments have shown efficacy in reducing disease severity and pruritus in patients with moderate to severe atopic dermatitis.

What prior FDA approvals exist?

The FDA has approved several treatments for atopic dermatitis, including upadacitinib and dupilumab. Upadacitinib is an oral selective Janus kinase (JAK) 1 inhibitor, approved for adults whose disease is not controlled with other systemic therapies. Dupilumab is a monoclonal antibody that inhibits IL-4 and IL-13, approved for patients aged 6 years and older. Both drugs are used for moderate to severe atopic dermatitis and have shown efficacy in reducing disease severity and pruritus. Other related JAK inhibitors like abrocitinib have also been approved for similar indications.

What other types of research exist?

Promising novel alternatives to Upadacitinib and Dupilumab for Atopic Dermatitis patients include: 1) Abrocitinib, a JAK1 inhibitor that has shown efficacy in clinical trials for AD. 2) Tralokinumab, an IL-13 inhibitor that targets a different pathway compared to Dupilumab. Both drugs have demonstrated potential in managing moderate to severe AD and may offer new options for patients in 2024.

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Monoclonal Antibodies

Upadacitinib vs Dupilumab for Eczema (Level Up Trial)

Phase 3

Waitlist Available

Research Sponsored by AbbVie

Eligibility Criteria Checklist

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

Must have

Chronic atopic dermatitis (AD) with onset of symptoms at least 3 years prior to baseline and participant meets Hanifin and Rajka criteria.

Eczema area and severity index (EASI) score ≥ 16; validated Investigator´s Global Assessment for AD (vIGA-AD) score ≥ 3 and ≥ 10% Body Surface Area Involvement of Atopic Dermatitis (BSA of AD) involvement at the Baseline Visit.

Must not have

History of an organ transplant which requires continued immunosuppression

Timeline

Screening 3 weeks

Treatment Varies

Follow Up at week 16

Awards & highlights

No Placebo-Only Group

Pivotal Trial

Summary

This trial is testing two drugs, upadacitinib and dupilumab, to find out which is better for treating moderate to severe atopic dermatitis in people aged 12 to 64 who haven't responded well to other treatments. Upadacitinib is taken regularly as a tablet, and dupilumab is administered according to its prescribed schedule. Both drugs work by reducing inflammation in the skin. Dupilumab is a relatively new drug that has transformed the treatment of atopic dermatitis by blocking specific immune pathways.

Who is the study for?

Adolescents and adults aged 12-64 with moderate to severe atopic dermatitis (eczema) that hasn't improved with systemic treatments can join. They must have had symptoms for over 3 years, significant itching, and a certain amount of skin affected as measured by medical scales.

What is being tested?

The trial is testing oral Upadacitinib against injectable Dupilumab in patients who haven't responded well to other treatments. It's a two-phase study lasting 32 weeks where participants are randomly assigned to one of the drugs and monitored through visits, blood tests, and questionnaires.

What are the potential side effects?

Possible side effects include reactions at the injection site for Dupilumab or gastrointestinal issues for Upadacitinib. Both drugs may also cause infections or allergic reactions due to their effect on the immune system.

Eligibility Criteria

Inclusion Criteria

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

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I have had chronic eczema for over 3 years.

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My eczema is severe, covering more than 10% of my body.

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I have had chronic eczema for over 3 years.

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My eczema is severe, covering more than 10% of my body.

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My eczema is severe, covering more than 10% of my body.

Exclusion Criteria

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

Select...

I have had an organ transplant and am on ongoing immunosuppressants.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ at week 16

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~at week 16

This trial's timeline: 3 weeks for screening, Varies for treatment, and at week 16 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Eczema

Secondary study objectives

Eczema

Percentage of Participants Achieving a Worst Pruritus Numerical Rating Scale of 0 or 1 (WP-NRS 0/1) among Participants with Baseline WP-NRS > 1

+2 more

Awards & Highlights

No Placebo-Only Group

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

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Group I: UpadacitinibExperimental Treatment1 Intervention

Participants will receive upadacitinib dose A daily in period 1. Eligible participants will receive upadacitinib dose B daily in period 2.

Group II: Dupilumab followed by UpadacitinibExperimental Treatment2 Interventions

Participants will receive dupilumab as per its label in period 1. Eligible participants will receive upadacitinib dose A in period 2.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Upadacitinib

2014

Completed Phase 3

~11250

Dupilumab

2017

Completed Phase 4

~11960

0 / 6Eligibility 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

Upadacitinib is a Janus kinase (JAK) 1 inhibitor that blocks the JAK-STAT signaling pathway, reducing the production of pro-inflammatory cytokines and thereby decreasing inflammation and symptoms like itching and rash. Dupilumab is an IL-4 and IL-13 inhibitor that blocks these interleukins, which are key drivers of the Th2 immune response in AD. By inhibiting IL-4 and IL-13, Dupilumab reduces inflammation and helps restore the skin barrier function. These mechanisms are crucial for AD patients as they offer targeted therapeutic options that effectively control the disease by addressing specific pathways in the immune system.