Rezpegaldesleukin maintenance data show durable responses in moderate-to-severe atopic dermatitis

New 52-week data from the phase 2b REZOLVE-AD study demonstrate sustained and deepening clinical responses with rezpegaldesleukin in patients with moderate-to-severe atopic dermatitis (AD), according to a February 10, 2026, announcement from Nektar Therapeutics.¹

Rezpegaldesleukin is an investigational biologic designed to stimulate regulatory T cells. In the 36-week blinded maintenance portion of REZOLVE-AD, both monthly (every 4 weeks [Q4W]) and quarterly (every 12 weeks [Q12W]) dosing regimens were associated with maintenance of previously achieved responses as well as new responses across multiple disease measures.

Study design and maintenance population

The global REZOLVE-AD phase 2b study enrolled 393 patients with moderate-to-severe AD. During the 16-week induction period, patients were randomized to receive one of three doses of rezpegaldesleukin or placebo. Patients who achieved at least a 50% reduction in Eczema Area and Severity Index (EASI-50) during induction were re-randomized to continue the same dose on a Q4W or Q12W schedule through week 52 in a blinded maintenance period.

Maintenance analyses focused on patients who achieved EASI-50 at week 16 and were re-randomized to continued therapy.

Durability of response at week 52

Among patients receiving the 24 µg/kg dose, 71% (n=36) of those on Q4W dosing and 83% (n=35) on Q12W dosing maintained EASI-75 responses at week 52. Maintenance of validated Investigator Global Assessment of Atopic Dermatitis (vIGA-AD) 0/1 responses was observed in 85% (n=14) and 63% (n=21) of patients in the Q4W and Q12W groups, respectively.

EASI-90 responses were maintained in 80% (n=18) of patients in the 24 µg/kg Q4W group and 78% (n=20) in the Q12W group. Maintenance of itch improvement, defined by Itch Numerical Rating Scale (NRS) response among those with baseline Itch NRS ≥4, was reported in 75% (n=25) and 77% (n=17) of patients, respectively.

Jonathan Silverberg, MD, PhD, MPH, stated, “These data show that rezpegaldesleukin, as a broad-based Treg agonist, is emerging as one of the most important mechanisms in development to treat atopic dermatitis. With both monthly and quarterly maintenance dosing, new and sustained responses were observed across the key endpoints of EASI-75, vIGA-0/1, and itch, and with a large proportion of patients achieving complete clearance with EASI-100.”

New and deepening responses over time

In addition to durability, investigators reported new responses during maintenance. Among re-randomized patients receiving 24 µg/kg Q4W dosing, 51% (n=19) achieved new EASI-75 responses and 33% achieved new EASI-90 responses by week 52. Comparable findings were observed with Q12W dosing.

A 2- to 5-fold increase in EASI-100 responses was reported during maintenance. Among all re-randomized patients, EASI-100 responses increased from 4% to 22% with Q4W dosing and from 9% to 18% with Q12W dosing between weeks 16 and 52. Among those with EASI-75 or vIGA-AD responses at maintenance baseline, EASI-100 responses increased from 6% to 30% with Q4W dosing and from 14% to 27% with Q12W dosing.

“These data highlight that rezpegaldesleukin offers a completely novel therapeutic modality for the potential treatment of atopic dermatitis with numerous advantages to existing classes,” said David Rosmarin, MD. “Importantly, we don't see any increased risk of incidence of conjunctivitis, oral herpes, oral ulcers, or malignancies with this MOA as has been observed with other mechanisms. The investigators are looking forward to initiating Phase 3 studies as quickly as possible.”

Safety findings

The safety profile observed during maintenance was consistent with findings from induction. The discontinuation rate due to adverse events was 3.5% among all aggregated patients. Treatment-emergent adverse events were reported in 72% of re-randomized rezpegaldesleukin-treated patients and 65% of placebo patients in maintenance. Injection site reactions were the most frequently reported events and were described as nearly all mild in severity, with a discontinuation rate of 0.7%.

“These new REZOLVE-AD study results reinforce the promise of the Treg mechanism to treat atopic dermatitis. In the induction part of REZOLVE-AD, we saw a rapid onset of EASI-75 response and itch relief early in treatment, and, for the first time with Tregs, we observed meaningful improvement in self-reported asthma control in patients with co-morbid asthma,” saidHoward W. Robin, president and CEO of Nektar Therapeutics. “The combined data from induction and maintenance now showcase the potential of a Treg biologic to offer compelling efficacy and safety advantages and less frequent maintenance dosing as compared to current mechanisms. We look forward to advancing to Phase 3 studies quickly with the goal of submitting a BLA in 2029.”

On February 10, 2026, rezpegaldesleukin received Fast Track designation from the FDA for moderate-to-severe AD in patients aged 12 years and older whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable.²

Based on these maintenance data, the company stated that it plans to advance rezpegaldesleukin into phase 3 clinical development, evaluating both monthly and quarterly maintenance dosing in patients with moderate-to-severe AD.

References

1. Nektar Therapeutics. New REZOLVE-AD Maintenance Data in Atopic Dermatitis Demonstrate Rezpegaldesleukin Resulted in Durable and New Responses Across Key Disease Measurements with Both Monthly and Quarterly Dosing. Nektar Therapeutics. February 10, 2026. Accessed February 10, 2026. https://ir.nektar.com/news-releases/news-release-details/new-rezolve-ad-maintenance-data-atopic-dermatitis-demonstrate
2. Nektar Therapeutics. Nektar Therapeutics Receives Fast Track Designation for Rezpegaldesleukin for the Treatment of Moderate-to-Severe Atopic Dermatitis. PR Newswire. February 10, 2026. Accessed February 10, 2026. https://www.prnewswire.com/news-releases/nektar-therapeutics-receives-fast-track-designation-for-rezpegaldesleukin-for-the-treatment-of-moderate-to-severe-atopic-dermatitis-302371995.html