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

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