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NCT07690371PHASE3Recruiting

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

Nektar Therapeutics

Start Date

6/29/2026

Completion Date

12/1/2028

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

Phoenix, Arizona 85037

United States

Nektar Investigative Site

North Little Rock, Arkansas 72117-2916

United States

Nektar Investigative Site

Fountain Valley, California 92708-3701

United States

Nektar Investigative Site

Los Angeles, California 90025-7014

United States

Nektar Investigative Site

Boca Raton, Florida 33486

United States

Nektar Investigative Site

St. Petersburg, Florida 33714

United States

Nektar Investigative Site

Tampa, Florida 33615-4537

United States

Nektar Investigative Site

Macon, Georgia 31217-3865

United States

Nektar Investigative Site

Boise, Idaho 83706-1337

United States

Nektar Investigative Site

Normal, Illinois 61761-6280

United States

Nektar Investigative Site

Bowling Green, Kentucky 42104

United States

Nektar Investigative Site

Owensboro, Kentucky 42301

United States

Nektar Investigative Site

Lafayette, Louisiana 70508

United States

Nektar Investigative Site

Omaha, Nebraska 68144-5604

United States

Nektar Investigative Site

Clifton, New Jersey 07013

United States

Nektar Investigative Site

New York, New York 10023

United States

Nektar Investigative Site

New York, New York 10128-0724

United States

Nektar Investigative Site

Wilmington, North Carolina 28405-2375

United States

Nektar Investigative Site

Oklahoma City, Oklahoma 73118-2872

United States