Recruiting

NCT Number: NCT07690371

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

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.

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Key information

Conditions

Moderate-to-severe Atopic Dermatitis

Age range

12 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Nektar Investigative Site

St. Petersburg, Florida, 33714, United States

Location status: Recruiting

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Rezpegaldesleukin

Drug

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Other names: NKTR-358

Placebo

Drug

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Primary outcomes

US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24

Time frame: Week 0 and Week 24

The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24

Time frame: Week 0 and Week 24

The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)

Time frame: Week 0 and Week 24

The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.

Secondary outcomes

US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)

Time frame: Week 0 and Week 24

The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)

Time frame: Week 0 and Week 24

The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Number of participants at week 6 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline

Time frame: Week 0 and Week 6

The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
Number of participants at week 24 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline

Time frame: Week 0 and Week 24

The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
Number of participants at week 6 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline

Time frame: Week 0 and Week 6

The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
Number of participants at week 24 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline

Time frame: Week 0 and Week 24

The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
Number of participants at week 6 achieving a 1.25-point or greater improvement in Atopic Dermatitis Sleep Scale Question 1 (ADSS Q1) in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline

Time frame: Week 0 and Week 6

The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
Number of participants at week 24 achieving a 1.25-point or greater improvement in ADSS Q1 in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline

Time frame: Week 0 and Week 24

The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
Change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline at Week 24 in the subpopulation of patients with a 0.5-point or greater ACQ-5 at baseline

Time frame: Week 0 and Week 24

The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
Number of participants at week 24 achieving a 0.5-point or greater improvement in ACQ-5 in the subset of participants with a 0.5-point or greater ACQ-5 at baseline

Time frame: Week 0 and Week 24

The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
Change in Sino-Nasal Outcome Test (SNOT-22) score from baseline at Week 24 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline

Time frame: Week 0 and Week 24

The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
Number of participants at Week 24 achieving a 8.9-point or greater reduction from baseline in SNOT-22 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline

Time frame: Week 0 and Week 24

The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1

Time frame: Week 0 and Week 24

The aIGA scale ranges from 0 to 1, with a lower score indicating improvement in atopic dermatitis.
Number of participants with treatment emergent adverse events (TEAEs)

Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment emergent serious adverse events

Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment related serious adverse events

Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment emergent adverse events of special interest

Time frame: Through participant study completion, approximately Week 56
Number of participants with treatment related adverse events of special interest

Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to treatment discontinuation

Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose hold

Time frame: Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose modifications

Time frame: Through participant study completion, approximately Week 56

Study contacts

Contact information is provided by the study sponsor or research team.

Nektar Recruitment

CONTACT

[email protected]

855-482-8676

Sponsors and collaborators

Lead sponsor

Nektar Therapeutics

Industry

Registry information

Official study title

A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis

Acronym: ZENITH AD-1

Important dates

Study start: 2026
Primary completion: 2028
Study completion: 2028
First posted: Jul 8, 2026
Registry last updated: Jul 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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