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
Status: Recruiting
Location: See all (12) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 12
Healthy Volunteers: f
View:
• 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
Locations
United States
California
Nektar Investigative Site
RECRUITING
Fountain Valley
Nektar Investigative Site
RECRUITING
Los Angeles
Florida
Nektar Investigative Site
RECRUITING
Boca Raton
Nektar Investigative Site
RECRUITING
St. Petersburg
Georgia
Nektar Investigative Site
RECRUITING
Macon
Illinois
Nektar Investigative Site
RECRUITING
Normal
Kentucky
Nektar Investigative Site
RECRUITING
Bowling Green
Nektar Investigative Site
RECRUITING
Owensboro
Louisiana
Nektar Investigative Site
RECRUITING
Lafayette
Nebraska
Nektar Investigative Site
RECRUITING
Omaha
New Jersey
Nektar Investigative Site
RECRUITING
Clifton
New York
Nektar Investigative Site
RECRUITING
New York
Contact Information
Primary
Nektar Recruitment
StudyInquiry@nektar.com
855-482-8676
Time Frame
Start Date:2026-06-29
Estimated Completion Date:2028-12
Participants
Target number of participants:510
Treatments
Experimental: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Rezpegaldesleukin every 2 weeks during the induction period