What side effects are associated with this type of intervention?

Common treatments for eczema that modulate interleukin pathways include drugs like Dupilumab and Nemolizumab. Dupilumab, an IL-4 receptor antagonist, can cause side effects such as injection site reactions, conjunctivitis, and nasopharyngitis. Nemolizumab, targeting IL-31, may lead to mild adverse events like exacerbation of atopic dermatitis, upper respiratory tract infections, and headaches. Both treatments are generally well-tolerated, but long-term safety data is still being gathered.

What prior FDA approvals exist?

Dupilumab is an FDA-approved treatment for moderate-to-severe atopic dermatitis (eczema) that works by inhibiting interleukin-4 and interleukin-13 signaling. This biologic therapy has shown efficacy in both adults and children. Other treatments include topical agents like pimecrolimus and tacrolimus, which are non-steroidal and inhibit calcineurin, thereby reducing inflammation. While Rezpegaldesleukin specifically targets interleukin-2 pathways, it is still under investigation and not yet FDA-approved.

What other types of research exist?

Promising novel alternatives to Rezpegaldesleukin for eczema patients include Tezepelumab, an anti-thymic stromal lymphopoietin monoclonal antibody, and various anti-interleukin-23 agents such as Ustekinumab, Mirikizumab, and Risankizumab. These treatments have shown efficacy in related inflammatory conditions and may offer new therapeutic options for eczema.

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Interleukin

Rezpegaldesleukin for Atopic Dermatitis (REZOLVE-AD Trial)

Phase 2

Recruiting

Research Sponsored by Nektar Therapeutics

Eligibility Criteria Checklist

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

Must have

AD disease severity at screening and randomization: EASI of 16 or higher, IGA of 3 or 4, BSA of 10% or more

Be older than 18 years old

Must not have

Other skin conditions that would interfere with assessment of AD

Men and women (of reproductive potential) unwilling to use birth control and women who are pregnant or breastfeeding

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from week 0 through week 54

Summary

This trial tests a modified protein called rezpegaldesleukin in adults with moderate to severe atopic dermatitis. The treatment aims to help the immune system reduce skin inflammation and symptoms.

Who is the study for?

Adults aged 18-70 with moderate-to-severe atopic dermatitis (AD) for over a year, who haven't responded well to topical treatments. Participants must have an EASI score of 16+, IGA of 3 or 4, and BSA involvement of 10%+. Exclusions include other skin conditions, certain infections like HIV/Hepatitis, cancer history within the last five years (with exceptions), pregnancy/breastfeeding women, recent live vaccines, immune suppression issues, prior AD biologic treatments or severe illnesses.

What is being tested?

The trial is testing Rezpegaldesleukin (Rezpeg), a pegylated form of interleukin-2 for treating AD. It's randomized and double-blind with four parallel groups: some get Rezpeg while others receive a placebo. The study includes initial treatment up to day 280 followed by safety follow-up until approximately day 378.

What are the potential side effects?

Potential side effects are not specified here but may include reactions typical to immunomodulating therapies such as injection site reactions, flu-like symptoms including fever and chills, fatigue, rash or worsening eczema.

Eligibility Criteria

Inclusion Criteria

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

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

Exclusion Criteria

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

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I don't have skin conditions that could affect eczema evaluation.

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I am not using birth control and am not pregnant or breastfeeding.

Select...

I have a history of weak immunity, with frequent or long-lasting infections.

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I have used immune therapies for my condition before.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from week 0 through week 54

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from week 0 through week 54

This trial's timeline: 3 weeks for screening, Varies for treatment, and from week 0 through week 54 for reporting.

Treatment Details

Study Objectives

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

Primary study objectives

Mean percent change in the Eczema Area and Severity Index (EASI) from baseline at Week 16

Secondary study objectives

Mean change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)

Mean change from baseline over the period between week 0 and week 54 in SCORAD

Mean percent change from baseline over the period between week 0 and week 54 in Eczema Area and Severity Index (EASI)

+8 more

Trial Design

12Treatment groups

Experimental Treatment

Placebo Group

Group I: Escape Therapy (open-label)Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 2 weeks during the maintenance period

Group II: Arm C2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen C every 12 weeks during the maintenance period

Group III: Arm C1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen C every 4 weeks during the maintenance period

Group IV: Arm CExperimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen C every 2 weeks during the induction period

Group V: Arm B2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen B every 12 weeks during the maintenance period

Group VI: Arm B1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen B every 4 weeks during the maintenance period

Group VII: Arm BExperimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen B every 4 weeks during the induction period

Group VIII: Arm A2Experimental Treatment2 Interventions

Rezpegaldesleukin Dose Regimen A every 12 weeks during the maintenance period

Group IX: Arm A1Experimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 4 weeks during the maintenance period

Group X: Arm AExperimental Treatment1 Intervention

Rezpegaldesleukin Dose Regimen A every 2 weeks during the induction period

Group XI: Arm D1Placebo Group1 Intervention

Placebo every 4 weeks during the maintenance period

Group XII: Arm DPlacebo Group1 Intervention

Placebo every 2 weeks during the induction period

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Placebo

1995

Completed Phase 3

~2670

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

Eczema treatments often target the immune system to reduce inflammation and alleviate symptoms. Rezpegaldesleukin, a pegylated-recombinant-human interleukin-2, modulates the IL-2 pathway to enhance regulatory T cell function, which helps control the immune response and reduce inflammation. Other treatments, such as ruxolitinib cream, inhibit the JAK-STAT pathway to decrease Th2-driven inflammation, reducing skin thickening and itch. Topical corticosteroids and calcineurin inhibitors suppress various inflammatory pathways to manage symptoms. Understanding these mechanisms is crucial for eczema patients as it helps tailor treatments to their specific immune responses, potentially improving efficacy and reducing side effects.

Ruxolitinib Cream Has Dual Efficacy on Pruritus and Inflammation in Experimental Dermatitis.JAK-STAT signaling pathway inhibition: a role for treatment of discoid lupus erythematosus and dermatomyositis.Recent developments in atopic dermatitis.