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