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REZOLVE-AD and Rezpegaldesleukin for Atopic Dermatitis, with Jonathan Silverberg, MD, PhD, MPH
Silverberg discussers 16-week data for rezpegaldesleukin in atopic dermatitis from the phase 2b REZOLVE-AD trial.
On June 24, 2025, Nektar Therapeutics announced positive results from the 16-week induction phase of its ongoing phase 2b REZOLVE-AD trial, highlighting the efficacy and safety of rezpegaldesleukin, an IL-pathway agonist designed to expand regulatory T cells (Tregs), in adults with moderate-to-severe atopic dermatitis.
In the study, 393 patients were randomized to receive rezpegaldesleukin at 1 of 3 dosing regimens—24 µg/kg every 2 weeks, 18 µg/kg every 2 weeks, or 24 µg/kg every 4 weeks—or placebo every 2 weeks. Patients who achieved at least 50% improvement in Eczema Area and Severity Index (EASI-50) by week 16 were rerandomized to continue treatment every 4 or 12 weeks in the trial’s maintenance phase.
The trial met its primary endpoint, with all three active treatment arms achieving statistically significant mean improvements in EASI scores from baseline at week 16 compared to placebo (P < .001). Key secondary endpoints were also met across all dose arms, including:
- EASI-75 and EASI-50 response rates,
- Body Surface Area improvement,
- vIGA-AD 0/1 (clear or almost clear skin),
- Itch NRS reduction among patients with baseline scores ≥4.
The release from Nektar Therapeutics highlighted the 24 µg/kg every 2 weeks regimen also reached statistical significance for EASI-90 at week 16, with efficacy consistent across patients with vIGA-AD 3 and vIGA-AD 4.
Pharmacodynamic data revealed a dose-dependent increase in circulating Tregs, with the high-dose group showing up to a 6-fold increase at week 16. This observed Treg expansion correlated with reductions in Th2-related inflammatory biomarkers, including TARC/CCL17, IL-19, periostin, and MDC/CCL22, confirming robust biological activity.
“These data show a fast onset of both EASI response and itch relief within the first few doses of rezpegaldesleukin treatment,” said study investigator Jonathan Silverberg, MD, PhD, MPH,professor of dermatology and director of clinical research at the George Washington University School of Medicine and Health Science. “This broad-based Treg mechanism may offer a meaningful alternative to other immune-modulating therapies in atopic dermatitis.”
For more on this announcement, check out our interview with Silverberg:
Relevant disclosures of interest for Silverberg include AbbVie, lamar, Aldena, Amgen, AObiome, Arcutis, Arena, Asana, Aslan, BioMX, Biosion, Bodewell, Boehringer Ingelheim, Bristol-Myers Squibb, and others.
