Tests rezpegaldesleukin against placebo for atopic dermatitis
Tests rezpegaldesleukin, compared with placebo, in people aged 12 and older with atopic dermatitis.
Plain-language title generated from the registry record
Registry title: A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis
Key facts
- Where
- Ancona, Catania, Florence, Milan, Naples, Pisa, Rome, and Rozzano, ItalySee the 10 sites
- Phase
- Phase 3
Where in Italy
- Azienda Ospedaliero-Universitaria delle MarcheAncona, ItalyNot yet recruiting
- Azienda Ospedaliero-Universitaria Policlinico G. Rodolico-San Marco Di CataniaCatania, ItalyNot yet recruiting
- Azienda USL Toscana CentroFlorence, ItalyNot yet recruiting
- Fondazione IRCCS Cà Granda Ospedale Maggiore PoliclinicoMilan, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria - Universita degli Studi della Campania Luigi VanvitelliNaples, ItalyNot yet recruiting
- Azienda Ospedaliera Universitaria Federico II Di NapoliNaples, ItalyNot yet recruiting
- Azienda Ospedaliero Universitaria PisanaPisa, ItalyNot yet recruiting
- Fondazione Policlinico Universitario Campus Bio-medico In Forma A Bbreviata FonRome, ItalyNot yet recruiting
- I.F.O. Istituti Fisioterapici OspitalieriRome, ItalyNot yet recruiting
- Humanitas Mirasole S.p.A.Rozzano, ItalyNot yet recruiting
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Nektar Therapeutics
- Trial code
- NCT07711418EU 2025-525129-11-00
- Record updated
- 8 September 2026
- Original description
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.Read full original descriptionShow less
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to- Severe Atopic Dermatitis
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.
Inclusion: 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: 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; History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit; 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; Are currently experiencing or have a history of unstable course of AD; Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal; Have a current or recent acute, active infection.