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NCT07711418PHASE3Recruiting

A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis

Nektar Therapeutics

Start Date

8/7/2026

Completion Date

1/1/2029

Summary

This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo. The estimated participant overall duration is approximately 15 months.

Eligibility Criteria

Age Range: 12 years to No maximum

Inclusion Criteria: * Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline * Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms ≥ 12 months prior to Screening as determined by the Investigator through patient interview and/or review of medical history at the Screening Visit * Patients must meet the following AD severity criteria: * IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline * ≥ 10.0% of BSA involvement at Screening and Baseline * EASI ≥ 16.0 at Screening and Baseline * Are candidates for systemic therapy and have history, documented by a physician and/or the Investigator, of inadequate response to existing topical medications within 6 months preceding Screening, or history of intolerance to a topical therapy * Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives Exclusion Criteria: * Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy * Are currently experiencing or have a history of unstable course of AD * History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit. * Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal * Have received any of the following treatments at any time before Screening: aldesleukin; investigational IL-2 analog; systemic biologic; oral JAKi; or any prior investigational agent for AD * Have a current or recent acute, active infection

Interventions

DRUG

Rezpegaldesleukin

DRUG

Placebo

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Conditions

Moderate-to-Severe Atopic Dermatitis

Locations

Nektar Investigative Site

Birmingham, Alabama 35203

United States

Nektar Investigative Site

Oxnard, California 93030

United States

Nektar Investigative Site

Palmdale, California 93551

United States

Nektar Investigative Site

Sacramento, California 95815

United States

Nektar Investigative Site

Tamarac, Florida 33321

United States

Nektar Investigative Site

Savannah, Georgia 31406

United States

Nektar Investigative Site

Metairie, Louisiana 70006

United States

Nektar Investigative Site

Kirksville, Missouri 63501

United States

Nektar Investigative Site

Lee's Summit, Missouri 64064

United States

Nektar Investigative Site

Las Vegas, Nevada 89144

United States

Nektar Investigative Site

Robbinsville, New Jersey 08691

United States

Nektar Investigative Site

The Bronx, New York 10455

United States

Nektar Investigative Site

Columbus, Ohio 43213

United States