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

Purpose

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.

Condition

  • Moderate-to-Severe Atopic Dermatitis

Eligibility

Eligible Ages
Over 12 Years
Eligible Sex
All
Accepts Healthy Volunteers
No

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

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Intervention Model Description
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.
Primary Purpose
Treatment
Masking
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

Arm Groups

ArmDescriptionAssigned Intervention
Experimental
Blinded Induction Period: Rezpegaldesleukin every 2 weeks 		Rezpegaldesleukin every 2 weeks during the induction period
  • Drug: Rezpegaldesleukin
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
    Other names:
    • NKTR-358
Placebo Comparator
Blinded Induction Period: Placebo 		Placebo every 2 weeks during the induction period
  • Drug: Placebo
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental
Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks 		Rezpegaldesleukin every 4 weeks during the maintenance period
  • Drug: Rezpegaldesleukin
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
    Other names:
    • NKTR-358
Experimental
Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks 		Rezpegaldesleukin every 12 weeks during the maintenance period
  • Drug: Rezpegaldesleukin
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
    Other names:
    • NKTR-358
Placebo Comparator
Blinded Maintenance Period: Placebo 		Placebo every 4 weeks during the maintenance period
  • Drug: Placebo
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
Experimental
Open-Label Escape 		Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
  • Drug: Rezpegaldesleukin
    Pharmaceutical form: Injection solution Route of administration: subcutaneous
    Other names:
    • NKTR-358

Recruiting Locations

Nektar Investigative Site
St. Petersburg, Florida 33714

More Details

Status
Recruiting
Sponsor
Nektar Therapeutics

Study Contact

Nektar Recruitment
855-482-8676
StudyInquiry@nektar.com