A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (ZENITH AD-1)
2. července 2026 aktualizováno: 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.
Přehled studie
Postavení
Nábor
Intervence / Léčba
Typ studie
Intervenční
Zápis (Odhadovaný)
510
Fáze
- Fáze 3
Kontakty a umístění
Tato část poskytuje kontaktní údaje pro ty, kteří studii provádějí, a informace o tom, kde se tato studie provádí.
Studijní kontakt
- Jméno: Nektar Recruitment
- Telefonní číslo: 855-482-8676
- E-mail: StudyInquiry@nektar.com
Studijní místa
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Florida
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St. Petersburg, Florida, Spojené státy, 33714
- Nábor
- Nektar Investigative Site
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Kritéria účasti
Výzkumníci hledají lidi, kteří odpovídají určitému popisu, kterému se říká kritéria způsobilosti. Některé příklady těchto kritérií jsou celkový zdravotní stav osoby nebo předchozí léčba.
Kritéria způsobilosti
Věk způsobilý ke studiu
- Dítě
- Dospělý
- Starší dospělý
Přijímá zdravé dobrovolníky
Ne
Popis
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
Studijní plán
Tato část poskytuje podrobnosti o studijním plánu, včetně toho, jak je studie navržena a co studie měří.
Jak je studie koncipována?
Detaily designu
- Primární účel: Léčba
- Přidělení: Randomizované
- Intervenční model: Paralelní přiřazení
- Maskování: Čtyřnásobek
Zbraně a zásahy
Skupina účastníků / Arm |
Intervence / Léčba |
|---|---|
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Experimentální: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Rezpegaldesleukin every 2 weeks during the induction period
|
Léková forma: Injekční roztok Cesta podání: subkutánní
Ostatní jména:
|
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Komparátor placeba: Blinded Induction Period: Placebo
Placebo every 2 weeks during the induction period
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Léková forma: Injekční roztok Cesta podání: subkutánní
|
|
Experimentální: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
Rezpegaldesleukin every 4 weeks during the maintenance period
|
Léková forma: Injekční roztok Cesta podání: subkutánní
Ostatní jména:
|
|
Experimentální: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
Rezpegaldesleukin every 12 weeks during the maintenance period
|
Léková forma: Injekční roztok Cesta podání: subkutánní
Ostatní jména:
|
|
Komparátor placeba: Blinded Maintenance Period: Placebo
Placebo every 4 weeks during the maintenance period
|
Léková forma: Injekční roztok Cesta podání: subkutánní
|
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Experimentální: Open-Label Escape
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
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Léková forma: Injekční roztok Cesta podání: subkutánní
Ostatní jména:
|
Co je měření studie?
Primární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
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
Časové okno: 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 an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
Časové okno: 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)
Časové okno: 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
|
Sekundární výstupní opatření
Měření výsledku |
Popis opatření |
Časové okno |
|---|---|---|
|
US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)
Časové okno: 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)
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
|
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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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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
Časové okno: 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)
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
|
Number of participants with treatment emergent serious adverse events
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
|
Number of participants with treatment related serious adverse events
Časové okno: 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
Časové okno: 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
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
|
Number of participants with TEAEs leading to treatment discontinuation
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
|
Number of participants with TEAEs leading to dose hold
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
|
|
Number of participants with TEAEs leading to dose modifications
Časové okno: Through participant study completion, approximately Week 56
|
Through participant study completion, approximately Week 56
|
Spolupracovníci a vyšetřovatelé
Zde najdete lidi a organizace zapojené do této studie.
Sponzor
Termíny studijních záznamů
Tato data sledují průběh záznamů studie a předkládání souhrnných výsledků na ClinicalTrials.gov. Záznamy ze studií a hlášené výsledky jsou před zveřejněním na veřejné webové stránce přezkoumány Národní lékařskou knihovnou (NLM), aby se ujistily, že splňují specifické standardy kontroly kvality.
Hlavní termíny studia
Začátek studia (Odhadovaný)
1. července 2026
Primární dokončení (Odhadovaný)
1. května 2028
Dokončení studie (Odhadovaný)
1. prosince 2028
Termíny zápisu do studia
První předloženo
2. července 2026
První předloženo, které splnilo kritéria kontroly kvality
2. července 2026
První zveřejněno (Aktuální)
8. července 2026
Aktualizace studijních záznamů
Poslední zveřejněná aktualizace (Aktuální)
8. července 2026
Odeslaná poslední aktualizace, která splnila kritéria kontroly kvality
2. července 2026
Naposledy ověřeno
1. července 2026
Více informací
Termíny související s touto studií
Další identifikační čísla studie
- 25-358-09
- 2025-524925-42-00 (Ctis)
Plán pro data jednotlivých účastníků (IPD)
Plánujete sdílet data jednotlivých účastníků (IPD)?
NE
Informace o lécích a zařízeních, studijní dokumenty
Studuje lékový produkt regulovaný americkým FDA
Ano
Studuje produkt zařízení regulovaný americkým úřadem FDA
Ne
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