Recruiting
Phase 3

Rezpegaldesleukin

Sponsor:

Nektar Therapeutics

Code:

NCT07690371

Conditions

Moderate-to-Severe Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

Interventions

Rezpegaldesleukin

Placebo

Study Details

Brief 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.

Conditions

Moderate-to-Severe Atopic Dermatitis

Study ID

NCT07690371

Start date

Jun 29, 2026

Status verified date

Aug, 2026

Completion date

Dec, 2028

Anticipated

Primary completion date

May, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 12+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

510 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Blinded Induction Period: Rezpegaldesleukin every 2 weeks

Rezpegaldesleukin every 2 weeks during the induction period

placebo comparator: Blinded Induction Period: Placebo

Placebo every 2 weeks during the induction period

experimental: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks

Rezpegaldesleukin every 4 weeks during the maintenance period

experimental: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks

Rezpegaldesleukin every 12 weeks during the maintenance period

placebo comparator: Blinded Maintenance Period: Placebo

Placebo every 4 weeks during the maintenance period

experimental: Open-Label Escape

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

Interventions

Rezpegaldesleukin

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Placebo

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Primary outcome measure

  • 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 ]
  • 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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Nektar Recruitment

855-482-8676StudyInquiry@nektar.com

Locations

Nektar Investigative Site

Recruiting

Fountain Valley, California, United States, 92708-3701

Nektar Investigative Site

Recruiting

Los Angeles, California, United States, 90025-7014

Nektar Investigative Site

Recruiting

Boca Raton, Florida, United States, 33486

Nektar Investigative Site

Recruiting

St. Petersburg, Florida, United States, 33714

Nektar Investigative Site

Recruiting

Macon, Georgia, United States, 31217-3865

Nektar Investigative Site

Recruiting

Normal, Illinois, United States, 61761-6280

Nektar Investigative Site

Recruiting

Bowling Green, Kentucky, United States, 42104

Nektar Investigative Site

Recruiting

Owensboro, Kentucky, United States, 42301

Nektar Investigative Site

Recruiting

Lafayette, Louisiana, United States, 70508

Nektar Investigative Site

Recruiting

Omaha, Nebraska, United States, 68144-5604

Nektar Investigative Site

Recruiting

Clifton, New Jersey, United States, 07013

Nektar Investigative Site

Recruiting

New York, New York, United States, 10023

More Information

Sponsor

Nektar Therapeutics

Last update posted

Aug 4, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Nektar Therapeutics on 2026-08-04.