Atopic Dermatitis Clinical Trials

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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 (13) 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
Alabama
Nektar Investigative Site
RECRUITING
Birmingham
California
Nektar Investigative Site
RECRUITING
Oxnard
Nektar Investigative Site
RECRUITING
Palmdale
Nektar Investigative Site
RECRUITING
Sacramento
Florida
Nektar Investigative Site
RECRUITING
Tamarac
Georgia
Nektar Investigative Site
RECRUITING
Savannah
Louisiana
Nektar Investigative Site
RECRUITING
Metairie
Missouri
Nektar Investigative Site
RECRUITING
Kirksville
Nektar Investigative Site
RECRUITING
Lee's Summit
New Jersey
Nektar Investigative Site
RECRUITING
Robbinsville
Nevada
Nektar Investigative Site
RECRUITING
Las Vegas
New York
Nektar Investigative Site
RECRUITING
The Bronx
Ohio
Nektar Investigative Site
RECRUITING
Columbus
Contact Information
Primary
Nektar Recruitment
StudyInquiry@nektar.com
855-482-8676
Time Frame
Start Date: 2026-08-07
Estimated Completion Date: 2029-01
Participants
Target number of participants: 510
Treatments
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
Related Therapeutic Areas
Sponsors
Leads: Nektar Therapeutics

This content was sourced from clinicaltrials.gov

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