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

Recruiting now · Phase 3 · Has a placebo group

Conditions studied: Moderate-to-Severe Atopic Dermatitis

In brief

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.

Key facts

Study ID

NCT07690371

Run by

Nektar Therapeutics

People needed

510

Starts

2026-06-29

Expected to finish

2028-12-01

Last updated by the study team

2026-08-04

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Nektar Investigative Site — Fountain Valley, California, United States (enrolling)
• Nektar Investigative Site — Los Angeles, California, United States (enrolling)
• Nektar Investigative Site — Boca Raton, Florida, United States (enrolling)
• Nektar Investigative Site — St. Petersburg, Florida, United States (enrolling)
• Nektar Investigative Site — Macon, Georgia, United States (enrolling)
• Nektar Investigative Site — Normal, Illinois, United States (enrolling)
• Nektar Investigative Site — Bowling Green, Kentucky, United States (enrolling)
• Nektar Investigative Site — Owensboro, Kentucky, United States (enrolling)
• Nektar Investigative Site — Lafayette, Louisiana, United States (enrolling)
• Nektar Investigative Site — Omaha, Nebraska, United States (enrolling)
• Nektar Investigative Site — Clifton, New Jersey, United States (enrolling)
• Nektar Investigative Site — New York, New York, United States (enrolling)

Full record on ClinicalTrials.gov

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