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Taking peoplePhase 3

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.

Key facts

Who runs it
Nektar Therapeutics
Where
Brno-Stred, Moravska Ostrava A Privoz, Pardubice I, Povel, and Prague, CzechiaSee the 6 sitesAlso in 9 other countries, 81 sites
Registry title
A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis
Status
Recruiting
Phase
Phase 3
People taking part
510 people, planned
Started
29 Jun 2026
Expected to end
Dec 2028
Type of study
Interventional, 6 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • Rezpegaldesleukin
  • Placebo
Record updated
21 October 2026

Who can take part

AI summary

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

The registry criteria, word for word

Show all 14 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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

Where in Czechia

Also in 9 other countries, 81 sites

  • Pratia Czech s.r.o.Brno-Stred, CzechiaNot yet recruiting
  • CCR Ostrava s.r.o.Moravska Ostrava A Privoz, CzechiaNot yet recruiting
  • Pratia Czech s.r.o.Pardubice I, CzechiaNot yet recruiting
  • Dermskin s.r.o.Povel, CzechiaNot yet recruiting
  • Fakultni nemocnice BulovkaPrague, CzechiaNot yet recruiting
  • Fakultni nemocnice Kralovske VinohradyPrague, CzechiaNot yet recruiting

About the trial

What the trial wants to find out

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

The estimated participant overall duration is approximately 15 months.

The 6 groups in the trial

  • Blinded Induction Period: Rezpegaldesleukin every 2 weeksTreatment being tested

    Rezpegaldesleukin every 2 weeks during the induction period

    Treatment: Rezpegaldesleukin

  • Blinded Induction Period: PlaceboPlacebo, for comparison

    Placebo every 2 weeks during the induction period

    Treatment: Placebo

  • Blinded Maintenance Period: Rezpegaldesleukin every 4 weeksTreatment being tested

    Rezpegaldesleukin every 4 weeks during the maintenance period

    Treatment: Rezpegaldesleukin

  • Blinded Maintenance Period: Rezpegaldesleukin every 12 weeksTreatment being tested

    Rezpegaldesleukin every 12 weeks during the maintenance period

    Treatment: Rezpegaldesleukin

  • Blinded Maintenance Period: PlaceboPlacebo, for comparison

    Placebo every 4 weeks during the maintenance period

    Treatment: Placebo

  • Open-Label EscapeTreatment being tested

    Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape

    Treatment: Rezpegaldesleukin

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Tests rezpegaldesleukin against placebo for atopic dermatitis in people aged 12 and olderGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Record updated
21 October 2026