Tests rezpegaldesleukin against placebo for atopic dermatitis in people aged 12 and older
Tests rezpegaldesleukin against a placebo in people 12 or older with moderate-to-severe 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
- Bialystok, Białystok, Chorzów, Cracow, Gdansk, Katowice, Lodz, Lublin, Poznan, Szczecin, Warszawa, and Wroclaw, PolandSee the 17 sites
- Phase
- Phase 3
AI summary: who the study is looking for
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 12 or older with moderate-to-severe atopic dermatitis that has lasted at least 12 months. It compares rezpegaldesleukin with placebo.
- Age
- 12 years or older
- Sex
- All sexes can join
- Disease stage
- Moderate-to-severe atopic dermatitis that began at least 12 months ago. IGA score of 3 or more, at least 10.0% of body surface affected, EASI of 16.0 or more.
- Earlier treatment
- Topical medicines did not work well enough in the last 6 months, or caused problems. Must be a candidate for systemic therapy. Cannot have had aldesleukin, an investigational IL-2 analog, a systemic biologic, an oral JAK inhibitor, or any earlier investigational drug for atopic dermatitis.
Main reasons for not taking part
- Other skin conditions, or a skin infection needing systemic antimicrobial treatment in the affected area
- Unstable course of atopic dermatitis
- History of chronic idiopathic urticaria, or urticaria from other causes within 4 weeks before randomization
- History of topical corticosteroid use suggesting a high risk of withdrawal
- Current or recent acute, active infection
Read by machine on 10 November 2026.
Where in Poland
- Specderm Poznanska sp.j.Bialystok, PolandNo longer taking part
- Niepubliczny Zakład Opieki Zdrowotnej Specjalistyczny Ośrodek Dermatologiczny "Dermal"Białystok, PolandNo longer taking part
- M2M Med. Badania Sp. z o.o.Chorzów, PolandNo longer taking part
- Centrum Medyczne All-Med Badania KliniczneCracow, PolandNo longer taking part
- Malopolskie Centrum KliniczneCracow, PolandNo longer taking part
- Penta Hospitals Badania Kliniczne sp. z o.o.Gdansk, PolandNo longer taking part
- Pro Familia Altera Sp. z o.o. Pro Familia Poradnia WielospecjalistycznaKatowice, PolandNo longer taking part
- DERMED Centrum Medyczne Sp. z o.o.Lodz, PolandNo longer taking part
- Centrum Zdrowia i Urody MAXXMEDLublin, PolandNo longer taking part
- Luxderm Specjalistyczny Gabinet Dermatologiczny Prof. Dr. Hab. N. Med. Dorota KrasowskaLublin, PolandNo longer taking part
- Centrum Alergologii Sp. z o.o.Poznan, PolandNo longer taking part
- Twoja Przychodnia-Szczecinskie Centrum Medyczne Sp. z o. o.Szczecin, PolandNo longer taking part
- ETG WarszawaWarszawa, PolandNo longer taking part
- Klinika Ambroziak DermatologiaWarszawa, PolandNo longer taking part
- dermMedica Sp. z o.oWroclaw, PolandNo longer taking part
- Sylwia Matusiewicz MATMEDICAWroclaw, PolandNo longer taking part
- WroMedica I Bielicka A Strzalkowska s cWroclaw, PolandNo longer taking part
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorTrial details
- Who runs it
- Nektar Therapeutics
- Trial code
- NCT07690371EU 2025-524925-42-00
- Record updated
- 21 October 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.