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# Nektar Sees Promising Data with Dermatitis Drug
- URL: https://www.fdaweb.com/nektar-sees-promising-data-with-dermatitis-drug/
- Published: 2025-06-24T12:00:00.000Z
- Updated: 2026-09-14T15:15:06.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5159405

Nektar Therapeutics is reporting promising results from a mid-stage clinical trial of its experimental therapy rezpegaldesleukin for patients with moderate-to-severe atopic dermatitis. The therapy met all primary and key secondary endpoints in a 16-week analysis of the global Phase 2b REZOLVE-AD study, it says.

The trial enrolled 393 patients who were randomized to receive one of three doses of rezpegaldesleukin or placebo, according to the company. Across all three active treatment groups, patients showed statistically significant improvements in Eczema Area and Severity Index (EASI) scores compared to placebo, it says. These improvements included major milestones such as EASI-75 and EASI-90 — indicating at least 75% and 90% reduction in disease severity — and improvements in body surface area affected and patient-reported itch scores.

Notably, Nektar says the highest dose group also achieved statistical significance for EASI-90, one of the most stringent efficacy benchmarks in eczema research. “These data show a fast onset of both EASI response and itch relief,” a company release says.

Rezpegaldesleukin is said to be designed to selectively stimulate the IL-2 receptor complex to expand Tregs, immune cells that help maintain tolerance and suppress inflammatory responses. According to Nektar, this approach may offer an advantage over existing therapies that broadly suppress immune pathways and may lead to adverse effects like conjunctivitis or infections, none of which were elevated in this study.

The trial’s safety profile was consistent with earlier studies, Nektar says, adding that the most common side effect was injection site reactions, which were seen in nearly 70% of treated patients. Other side effects more common in the treatment groups than placebo included eosinophilia, fever, headache, and joint pain, though no significant safety signals emerged.

In February, FDA granted rezpegaldesleukin a fast track status for moderate-to-severe atopic dermatitis in patients 12 and older whose disease is not adequately controlled with topical therapies. Nektar is also conducting a Phase 2 study of rezpegaldesleukin in alopecia areata, a separate autoimmune condition, with results expected in the fourth quarter.