A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (ZENITH AD-2)

Nektar Therapeutics

Status and phase: Enrolling; Phase 3

Conditions: Moderate-to-Severe Atopic Dermatitis

Treatments: Drug: Rezpegaldesleukin; Drug: Placebo

Study type: Interventional

Funder types: Industry

Identifiers

NCT07711418

2025-525129-11-00 (EU Trial (CTIS) Number)

25-358-10

2025

Details and patient eligibility

About

This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.

The estimated participant overall duration is approximately 15 months.

Enrollment: 510 estimated patients

Sex: All

Ages: 12+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline

• Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms

  ≥ 12 months prior to Screening as determined by the Investigator through patient interview and/or review of medical history at the Screening Visit

• Patients must meet the following AD severity criteria:

• IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline

• ≥ 10.0% of BSA involvement at Screening and Baseline

• EASI ≥ 16.0 at Screening and Baseline

• Are candidates for systemic therapy and have history, documented by a physician and/or the Investigator, of inadequate response to existing topical medications within 6 months preceding Screening, or history of intolerance to a topical therapy

• Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives

Exclusion criteria

• Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy
• Are currently experiencing or have a history of unstable course of AD
• History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit.
• Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal
• Have received any of the following treatments at any time before Screening: aldesleukin; investigational IL-2 analog; systemic biologic; oral JAKi; or any prior investigational agent for AD
• Have a current or recent acute, active infection

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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510 participants in 6 patient groups, including a placebo group

Blinded Induction Period: Rezpegaldesleukin every 2 weeks

Experimental group

Description:

Rezpegaldesleukin every 2 weeks during the induction period

Treatment:

Drug: Rezpegaldesleukin

Blinded Induction Period: Placebo

Placebo Comparator group

Description:

Placebo every 2 weeks during the induction period

Treatment:

Drug: Placebo

Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks

Experimental group

Description:

Rezpegaldesleukin every 4 weeks during the maintenance period

Treatment:

Drug: Rezpegaldesleukin

Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks

Experimental group

Description:

Rezpegaldesleukin every 12 weeks during the maintenance period

Treatment:

Drug: Rezpegaldesleukin

Blinded Maintenance Period: Placebo

Placebo Comparator group

Description:

Placebo every 4 weeks during the maintenance period

Treatment:

Drug: Placebo

Open-Label Escape

Experimental group

Description:

Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape

Treatment:

Drug: Rezpegaldesleukin