Phase 3 Trial of Rezpegaldesleukin Injections for Moderate-to-Severe Atopic Dermatitis in Patients Aged 12 and Older

What this Trial Is About

Researchers are evaluating Rezpegaldesleukin, a drug being studied for patients aged 12 years and older with moderate to severe atopic dermatitis. This Phase 3, randomized, double-blind study compares Rezpegaldesleukin to a placebo to assess its effect on the condition. The study is designed as a parallel group trial and aims to understand treatment outcomes over approximately 15 months. Participants receive Rezpegaldesleukin injections subcutaneously during an induction period every 2 weeks and then during a maintenance period at varying intervals of every 4 or 12 weeks. Some participants will receive placebo injections on a similar schedule during the induction and maintenance periods. An open-label escape phase allows dosing frequency to be adjusted by the investigator. The study includes both blinded and open-label phases to monitor responses. During the study, participants will undergo regular assessments including Investigators Global Assessment IGA scores, Eczema Area and Severity Index EASI scores, and symptom rating scales for itch, skin pain, and sleep impact. Researchers will also track asthma control and sinusitis symptoms in applicable patients. Safety is monitored through reports of adverse events throughout the study. The total participation time is about 15 months, with key evaluations at weeks 0, 6, 24, and ongoing safety follow-ups.

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