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A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (ZENITH AD-1)

2. juli 2026 opdateret af: Nektar Therapeutics

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

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

510

Fase

  • Fase 3

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Forenede Stater
    • Florida
      • St. Petersburg, Florida, Forenede Stater, 33714
        • Rekruttering
        • Nektar Investigative Site

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Barn
  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Rezpegaldesleukin every 2 weeks during the induction period
Medicin: Rezpegaldesleukin
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Andre navne:
  • NKTR-358
Placebo komparator: Blinded Induction Period: Placebo
Placebo every 2 weeks during the induction period
Medicin: Placebo
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Eksperimentel: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
Rezpegaldesleukin every 4 weeks during the maintenance period
Medicin: Rezpegaldesleukin
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Andre navne:
  • NKTR-358
Eksperimentel: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
Rezpegaldesleukin every 12 weeks during the maintenance period
Medicin: Rezpegaldesleukin
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Andre navne:
  • NKTR-358
Placebo komparator: Blinded Maintenance Period: Placebo
Placebo every 4 weeks during the maintenance period
Medicin: Placebo
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Eksperimentel: Open-Label Escape
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
Medicin: Rezpegaldesleukin
Lægemiddelform: Injektionsopløsning Indgivelsesvej: subkutan
Andre navne:
  • NKTR-358

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
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
Tidsramme: Week 0 and 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
Tidsramme: Week 0 and 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)
Tidsramme: Week 0 and Week 24
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Week 0 and Week 24

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)
Tidsramme: Week 0 and Week 24
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
Week 0 and Week 24
Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)
Tidsramme: Week 0 and Week 24
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
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
Tidsramme: Week 0 and Week 6
The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
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
Tidsramme: Week 0 and Week 24
The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
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
Tidsramme: Week 0 and Week 6
The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
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
Tidsramme: Week 0 and Week 24
The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
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
Tidsramme: Week 0 and Week 6
The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
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
Tidsramme: Week 0 and Week 24
The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
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
Tidsramme: Week 0 and Week 24
The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
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
Tidsramme: Week 0 and Week 24
The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
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
Tidsramme: Week 0 and Week 24
The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
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
Tidsramme: Week 0 and Week 24
The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
Week 0 and Week 24
Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1
Tidsramme: Week 0 and Week 24
The aIGA scale ranges from 0 to 1, with a lower score indicating improvement in atopic dermatitis.
Week 0 and Week 24
Number of participants with treatment emergent adverse events (TEAEs)
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with treatment emergent serious adverse events
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with treatment related serious adverse events
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with treatment emergent adverse events of special interest
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with treatment related adverse events of special interest
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to treatment discontinuation
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose hold
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56
Number of participants with TEAEs leading to dose modifications
Tidsramme: Through participant study completion, approximately Week 56
Through participant study completion, approximately Week 56

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Nektar Therapeutics

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. maj 2028

Studieafslutning (Anslået)

1. december 2028

Datoer for studieregistrering

Først indsendt

2. juli 2026

Først indsendt, der opfyldte QC-kriterier

2. juli 2026

Først opslået (Faktiske)

8. juli 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

8. juli 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

2. juli 2026

Sidst verificeret

1. juli 2026

Mere information

Begreber relateret til denne undersøgelse

Andre undersøgelses-id-numre

  • 25-358-09
  • 2025-524925-42-00 (Ctis)

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

INGEN

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

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Kliniske forsøg med Moderat til svær atopisk dermatitis

Kliniske forsøg med Rezpegaldesleukin

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