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

NCT07690371 | Recruiting Phase 3 DMC FDA Drug

• 2 other identifiers: 25-358-092025-524925-42-00
• Study Type: interventional
• Target: 510
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Moderate-to-Severe Atopic Dermatitis

Outcome Measures

Primary Outcomes (3)

• 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

  The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.

  Week 0 and Week 24

• Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24

  The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.

  Week 0 and Week 24

• 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)

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

  Week 0 and Week 24

Secondary Outcomes (21)

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

  Week 0 and Week 24

• Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)

  Week 0 and Week 24

• 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

  Week 0 and Week 6

• 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

  Week 0 and Week 24

• 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

  Week 0 and Week 6

Study Arms (6)

Blinded Induction Period: Rezpegaldesleukin every 2 weeks

EXPERIMENTAL

Rezpegaldesleukin every 2 weeks during the induction period

Drug: Rezpegaldesleukin

Blinded Induction Period: Placebo

PLACEBO COMPARATOR

Placebo every 2 weeks during the induction period

Drug: Placebo

Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks

EXPERIMENTAL

Rezpegaldesleukin every 4 weeks during the maintenance period

Drug: Rezpegaldesleukin

Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks

EXPERIMENTAL

Rezpegaldesleukin every 12 weeks during the maintenance period

Drug: Rezpegaldesleukin

Blinded Maintenance Period: Placebo

PLACEBO COMPARATOR

Placebo every 4 weeks during the maintenance period

Drug: Placebo

Open-Label Escape

EXPERIMENTAL

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

Drug: Rezpegaldesleukin

Interventions

Rezpegaldesleukin DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Also known as: NKTR-358

Blinded Induction Period: Rezpegaldesleukin every 2 weeks; Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks; Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks; Open-Label Escape

Placebo DRUG

Pharmaceutical form: Injection solution Route of administration: subcutaneous

Blinded Induction Period: Placebo; Blinded Maintenance Period: Placebo

Eligibility Criteria

• Age: 12 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nektar Therapeutics: lead

Study Sites (1)

Nektar Investigative Site

St. Petersburg, Florida, 33714, United States

RECRUITING

Central Study Contacts

Nektar Recruitment

CONTACT

855-482-8676; StudyInquiry@nektar.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Patients will be randomized to rezpegaldesleukin or placebo for the Blinded Induction Period. The randomized double-blind study treatment duration will be up to 52 weeks. The final safety follow-up visit will be 8 weeks after the last dose for participants not entering the long-term extension study. At Week 24, patients who had an adequate response to treatment will be re-randomized to either rezpegaldesleukin (every 4 weeks or every 12 weeks), or placebo every 4 weeks as blinded maintenance treatment. Patients assigned to the every 12 week rezpegaldesleukin regimen will receive placebo injections during the intervening monthly visits to maintain the blind. Patients who did not achieve adequate response may receive open label escape with rezpegaldesleukin until the end of the treatment period. Additionally, patients who were re-randomized to the Blinded Maintenance Period and have worsening atopic dermatitis will have the option to receive open label escape therapy.

Study Record Dates

• First Submitted: July 2, 2026
• First Posted: July 8, 2026
• Study Start: July 1, 2026
• Primary Completion (Estimated): May 1, 2028
• Study Completion (Estimated): December 1, 2028
• Last Updated: July 8, 2026

Record last verified: 2026-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)