Data from a previous phase 1b trial show improvements in the Eczema Area and Severity Index (EASI)-75 compared with the placebo at 12 weeks.
The FDA granted fast track designation to rezpegaldesleukin for the treatment of patients 12 years and older with moderate-to-severe atopic dermatitis whose disease is not controlled with topical prescription therapies or for which those therapies are not advisable.1
Patients taking placebo achieved the end point at 20%, compared to 25% of patients taking 12 µg/kg rezpegaldesleukin and 41% taking 24 µg/kg. | Image Credit: ltyuan | stock.adobe.com
"We are pleased that rezpegaldesleukin has been designated a Fast Track product," Jonathan Zalevsky, PhD, senior vice president and chief research and development officer at Nektar Therapeutics, said in a news release.1 "Rezpegaldesleukin has the potential to address a significant unmet need for the millions of patients living with moderate-to-severe atopic dermatitis. We remain on track to announce topline data from the induction period of our phase 2b REZOLVE-AD study in the second quarter of this year. This designation will now allow us to collaborate closely with the agency on the design of the registrational program for rezpegaldesleukin once we've completed phase 2."
In a previous phase 1b trial, rezpegaldesleukin demonstrated improvements in the Eczema Area and Severity Index (EASI)-75 compared with placebo at 12 weeks. Patients taking placebo achieved the end point at 20%, compared to 25% of patients taking 12 µg/kg rezpegaldesleukin and 41% taking 24 µg/kg. Additionally, there were improvements in affected body surface area (BSA), with least squares mean percentage being 36, 55, and 72, respectively, and improvements in Dermatology Life Quality Index being 9, 48, and 78, respectively. Further, the least squares mean percentage of the Patient-Oriented Eczema Measure was 15, 44, and 58, respectively.2
In January 2025, Nektar announced the completion of the targeted enrollment for the REZOLVE-AD (NCT06136741) phase 2b study of rezpegaldesleukin.
Trial Name: A Phase 2b Study to Evaluate Rezpegaldesleukin (Rezpeg) in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis (REZOLVE-AD)
ClinicalTrials.gov ID: NCT06136741
Sponsor: Nektar Therapeutics
Completion Date (Estimated): December 2026
"We are pleased to announce that we reached our target enrollment for our 396-patient Phase 2b trial of rezpegaldesleukin," Howard W. Robin, president and CEO of Nektar, said in a news release.2 “Less than 10% of the 30 million atopic dermatitis patients who can receive biologics in the US and Europe are currently receiving treatment, and we believe that novel mechanisms are key to helping more patients with this chronic and serious skin disorder. We look forward to announcing the topline data from the 16-week induction treatment period in this study in the second quarter of 2025."
The 2b trial is a randomized, double-blind, 4-arm study that is being used to assess rezpegaldesleukin for adults with moderate-to-severe atopic dermatitis. The screening duration is 15 to 35 days, the induction period is 16 weeks, the maintenance period is from week 16 to week 52, and the posttreatment period is for an additional year, up to week 104. Patients included had a disease severity at screening and randomization for an EASI of 16 or higher, investigator global assessment of 3 or 4, and BSA of 10% or more. Patients also had a documented history of inadequate response or inadvisability of topical treatment.4
The primary end point includes mean percent change in EASI from baseline at week 16, and secondary outcomes include proportion of patients achieving Validated Investigator Global Assessment for Atopic Dermatitis, EASI-75, EASI-90, EASI-50, mean change from baseline to week 104 in BSA, incidence of serious adverse events (AEs), and incidence of treatment-emergent AEs.4
