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 Previously Treated with a Biologic and/or Oral JAK inhibitor Therapy (Trial Not Registered)

This trial aims to investigate the safety and efficacy of Rezpegaldesleukin (NKTR-358) iin patients with moderate to severe atopic dermatitis previously treatment with systemic biologic and/or JAK inhibitor therapy. Participants will receive doses of the study treatment for up to a year (52 weeks). This would include administering doses of study treatment (Rezpegaldesleukin 24ug/kg subcutaneous injections) or placebo every 2 weeks for the first 24 weeks. From week 24 onwards, participants will be regrouped to receive study treatment 4 weekly, 12 weekly, or placebo 4 weekly. Participants will be required to attend a total of 17 onsite visits with 2 phone call visits for this trial.

Trial phase

Phase 3

Trial participation type

This trial has been designed for the Clinical Research of a Drug.

Principal investigator

Prof Johannes S Kern

Key inclusion data

Partcipants with confirmed diagnosis of chronic atopic dermatitis with signs and symptoms for at least one year prior to commencing trial. Participant must have had prior treatment with systemic biologic and/or JAK inhibitor therapy for atopic dermatitis. Participant must not have had history of eczema herpeticum. Participant must not have had history of chronic idiopathic urticaria.