A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (ZENITH AD-2)
4 de setembro de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
510
Estágio
- Fase 3
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Nektar Recruitment
- Número de telefone: 855-482-8676
- E-mail: StudyInquiry@nektar.com
Locais de estudo
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Alabama
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Birmingham, Alabama, Estados Unidos, 35203
- Recrutamento
- Nektar Investigative Site
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California
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Oxnard, California, Estados Unidos, 93030
- Recrutamento
- Nektar Investigative Site
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Palmdale, California, Estados Unidos, 93551
- Recrutamento
- Nektar Investigative Site
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Sacramento, California, Estados Unidos, 95815
- Recrutamento
- Nektar Investigative Site
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Florida
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Tamarac, Florida, Estados Unidos, 33321
- Recrutamento
- Nektar Investigative Site
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Georgia
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Savannah, Georgia, Estados Unidos, 31406
- Recrutamento
- Nektar Investigative Site
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Louisiana
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Metairie, Louisiana, Estados Unidos, 70006
- Recrutamento
- Nektar Investigative Site
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Missouri
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Kirksville, Missouri, Estados Unidos, 63501
- Recrutamento
- Nektar Investigative Site
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Lee's Summit, Missouri, Estados Unidos, 64064
- Recrutamento
- Nektar Investigative Site
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Nevada
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Las Vegas, Nevada, Estados Unidos, 89144
- Recrutamento
- Nektar Investigative Site
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New Jersey
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Robbinsville, New Jersey, Estados Unidos, 08691
- Recrutamento
- Nektar Investigative Site
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New York
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The Bronx, New York, Estados Unidos, 10455
- Recrutamento
- Nektar Investigative Site
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Ohio
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Columbus, Ohio, Estados Unidos, 43213
- Recrutamento
- Nektar Investigative Site
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Filho
- Adulto
- Adulto mais velho
Aceita Voluntários Saudáveis
Não
Descrição
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
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Quadruplicar
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
|---|---|
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Experimental: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Rezpegaldesleukin every 2 weeks during the induction period
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
Outros nomes:
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Comparador de Placebo: Blinded Induction Period: Placebo
Placebo every 2 weeks during the induction period
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
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Experimental: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
Rezpegaldesleukin every 4 weeks during the maintenance period
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
Outros nomes:
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Experimental: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
Rezpegaldesleukin every 12 weeks during the maintenance period
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
Outros nomes:
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Comparador de Placebo: Blinded Maintenance Period: Placebo
Placebo every 4 weeks during the maintenance period
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
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Experimental: Open-Label Escape
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
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Forma farmacêutica: Solução injetável Via de administração: subcutânea
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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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
Prazo: Week 0 and Week 24
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The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
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Week 0 and Week 24
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Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
Prazo: 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
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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)
Prazo: Week 0 and Week 24
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The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
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Week 0 and Week 24
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
|
US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)
Prazo: Week 0 and Week 24
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The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
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Week 0 and Week 24
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Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)
Prazo: Week 0 and Week 24
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The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
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Week 0 and Week 24
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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
Prazo: Week 0 and Week 6
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The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
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Week 0 and Week 6
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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
Prazo: Week 0 and Week 24
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The itch NRS goes from 0 to 10, with higher score indicating more severe itch.
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Week 0 and Week 24
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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
Prazo: Week 0 and Week 6
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The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
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Week 0 and Week 6
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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
Prazo: Week 0 and Week 24
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The Skin Pain NRS goes from 0 to 10, with higher score indicating more severe pain.
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Week 0 and Week 24
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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
Prazo: Week 0 and Week 6
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The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
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Week 0 and Week 6
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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
Prazo: Week 0 and Week 24
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The ADSS Q1 goes from 0 to 4, with higher score indicating more difficulty sleeping.
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Week 0 and Week 24
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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
Prazo: Week 0 and Week 24
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The ACQ-5 goes from 0 to 6, with higher score indicating worse asthma control.
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Week 0 and Week 24
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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
Prazo: 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
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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
Prazo: Week 0 and Week 24
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The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
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Week 0 and Week 24
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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
Prazo: Week 0 and Week 24
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The SNOT-22 scores range from 0 to 110, with a higher score indicating more severe symptoms
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Week 0 and Week 24
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Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1
Prazo: Week 0 and Week 24
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The aIGA scale ranges from 0 to 1, with a lower score indicating improvement in atopic dermatitis.
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Week 0 and Week 24
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Number of participants with treatment emergent adverse events (TEAEs)
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
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Number of participants with treatment emergent serious adverse events
Prazo: Through participant study completion, approximately Week 56
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Through participant study completion, approximately Week 56
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Number of participants with treatment related serious adverse events
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
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Number of participants with treatment emergent adverse events of special interest
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
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Number of participants with treatment related adverse events of special interest
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
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Number of participants with TEAEs leading to treatment discontinuation
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
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Number of participants with TEAEs leading to dose hold
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
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Number of participants with TEAEs leading to dose modifications
Prazo: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Diretor de estudo: Study Director, Nektar Therapeutics
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
7 de agosto de 2026
Conclusão Primária (Estimado)
1 de junho de 2028
Conclusão do estudo (Estimado)
1 de janeiro de 2029
Datas de inscrição no estudo
Enviado pela primeira vez
14 de julho de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
14 de julho de 2026
Primeira postagem (Real)
17 de julho de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
8 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
4 de setembro de 2026
Última verificação
1 de setembro de 2026
Mais Informações
Termos relacionados a este estudo
Outros números de identificação do estudo
- 25-358-10
- 2025 (Concessão/Contrato do NIH dos EUA: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-525129-11-00 (Ctis)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Sim
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
Essas informações foram obtidas diretamente do site clinicaltrials.gov sem nenhuma alteração. Se você tiver alguma solicitação para alterar, remover ou atualizar os detalhes do seu estudo, entre em contato com register@clinicaltrials.gov. Assim que uma alteração for implementada em clinicaltrials.gov, ela também será atualizada automaticamente em nosso site .