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

Official 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

Overview

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.

Interventions

• Drug Rezpegaldesleukin
  Pharmaceutical form: Injection solution Route of administration: subcutaneous
• Drug Placebo
  Pharmaceutical form: Injection solution Route of administration: subcutaneous

Primary outcome measures

• 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]
• 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]
• 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]

Secondary outcome measures (12)

• 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]
• Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90) [Time frame: 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 [Time frame: 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 [Time frame: 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 [Time frame: Week 0 and Week 6]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]
• 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation

Randomized

Model

Parallel assignment

Masking

Quadruple blind

Primary purpose

Treatment

Study locations

United States · 12 centers

• Nektar Investigative Site — Fountain Valley
• Nektar Investigative Site — Los Angeles
• Nektar Investigative Site — Boca Raton
• Nektar Investigative Site — St. Petersburg
• Nektar Investigative Site — Macon
• Nektar Investigative Site — Normal
• Nektar Investigative Site — Bowling Green
• Nektar Investigative Site — Owensboro
• … and 4 more centers

Identifiers

NCT: NCT07690371 · 25-358-09 · 2025-524925-42-00

Primary sources (government registries)

• ClinicalTrials.gov (US NIH)

View this study on ClinicalTrials.gov ↗