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Clinical Trials in the USA / NCT07690371
Recruiting Phase 3

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

NCT07690371 · tracked via the Priya Life Science USA tracker
Sponsor
Nektar Therapeutics
Phase
Phase 3
Started
2026-06-29
Last updated
2026-09-14

Condition(s) studied

Moderate-to-Severe Atopic Dermatitis

Investigational drug(s) / intervention(s)

RezpegaldesleukinPlacebo

Rezpegaldesleukin: Pharmaceutical form: Injection solution Route of administration: subcutaneous

Placebo: Pharmaceutical form: Injection solution Route of administration: subcutaneous

Study summary

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.

Eligibility

Sex
ALL
Min age
12 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (19)

FacilityCityRegionStatus
Nektar Investigative Site Phoenix Arizona Recruiting
Nektar Investigative Site North Little Rock Arkansas Recruiting
Nektar Investigative Site Fountain Valley California Recruiting
Nektar Investigative Site Los Angeles California Recruiting
Nektar Investigative Site Boca Raton Florida Recruiting
Nektar Investigative Site St. Petersburg Florida Recruiting
Nektar Investigative Site Tampa Florida Recruiting
Nektar Investigative Site Macon Georgia Recruiting
Nektar Investigative Site Boise Idaho Recruiting
Nektar Investigative Site Normal Illinois Recruiting
Nektar Investigative Site Bowling Green Kentucky Recruiting
Nektar Investigative Site Owensboro Kentucky Recruiting
Nektar Investigative Site Lafayette Louisiana Recruiting
Nektar Investigative Site Omaha Nebraska Recruiting
Nektar Investigative Site Clifton New Jersey Recruiting
Nektar Investigative Site New York New York Recruiting
Nektar Investigative Site New York New York Recruiting
Nektar Investigative Site Wilmington North Carolina Recruiting
Nektar Investigative Site Oklahoma City Oklahoma Recruiting

More Nektar Therapeutics trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07690371 on ClinicalTrials.gov ↗ ← All trials in the USA