NCT07690371 · Nektar Therapeutics
A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis
(ZENITH AD-1)
What this study is about
This is an interventional, randomly assigned, 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.
View original scientific 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. The estimated participant overall duration is approximately 15 months.
Interventions
DRUG
Rezpegaldesleukin
Pharmaceutical form: Injection solution Route of administration: subcutaneous
DRUG
Placebo
Pharmaceutical form: Injection solution Route of administration: subcutaneous
Primary outcome measures
US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24
Time frame: Week 0 and Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
Time frame: Week 0 and Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)
Time frame: Week 0 and Week 24
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- St. Petersburg, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations