A Phase 3 Study of Rezpegaldesleukin (NKTR-358) for Patients ≥ 12 Years of Age With Moderate-to-Severe Atopic Dermatitis (ZENITH AD-1)
9. september 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Intervensjon / Behandling
Studietype
Intervensjonell
Registrering (Antatt)
510
Fase
- Fase 3
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Nektar Recruitment
- Telefonnummer: 855-482-8676
- E-post: StudyInquiry@nektar.com
Studiesteder
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Arizona
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Phoenix, Arizona, Forente stater, 85037
- Rekruttering
- Nektar Investigative Site
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Arkansas
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North Little Rock, Arkansas, Forente stater, 72117-2916
- Rekruttering
- Nektar Investigative Site
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California
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Fountain Valley, California, Forente stater, 92708-3701
- Rekruttering
- Nektar Investigative Site
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Los Angeles, California, Forente stater, 90025-7014
- Rekruttering
- Nektar Investigative Site
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Florida
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Boca Raton, Florida, Forente stater, 33486
- Rekruttering
- Nektar Investigative Site
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St. Petersburg, Florida, Forente stater, 33714
- Rekruttering
- Nektar Investigative Site
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Tampa, Florida, Forente stater, 33615-4537
- Rekruttering
- Nektar Investigative Site
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Georgia
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Macon, Georgia, Forente stater, 31217-3865
- Rekruttering
- Nektar Investigative Site
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Idaho
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Boise, Idaho, Forente stater, 83706-1337
- Rekruttering
- Nektar Investigative Site
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Illinois
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Normal, Illinois, Forente stater, 61761-6280
- Rekruttering
- Nektar Investigative Site
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Kentucky
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Bowling Green, Kentucky, Forente stater, 42104
- Rekruttering
- Nektar Investigative Site
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Owensboro, Kentucky, Forente stater, 42301
- Rekruttering
- Nektar Investigative Site
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Louisiana
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Lafayette, Louisiana, Forente stater, 70508
- Rekruttering
- Nektar Investigative Site
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Nebraska
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Omaha, Nebraska, Forente stater, 68144-5604
- Rekruttering
- Nektar Investigative Site
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New Jersey
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Clifton, New Jersey, Forente stater, 07013
- Rekruttering
- Nektar Investigative Site
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New York
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New York, New York, Forente stater, 10023
- Rekruttering
- Nektar Investigative Site
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New York, New York, Forente stater, 10128-0724
- Rekruttering
- Nektar Investigative Site
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North Carolina
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Wilmington, North Carolina, Forente stater, 28405-2375
- Rekruttering
- Nektar Investigative Site
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Oklahoma
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Oklahoma City, Oklahoma, Forente stater, 73118-2872
- Rekruttering
- Nektar Investigative Site
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Barn
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Firemannsrom
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Rezpegaldesleukin every 2 weeks during the induction period
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
Andre navn:
|
|
Placebo komparator: Blinded Induction Period: Placebo
Placebo every 2 weeks during the induction period
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
|
|
Eksperimentell: Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
Rezpegaldesleukin every 4 weeks during the maintenance period
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
Andre navn:
|
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Eksperimentell: Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
Rezpegaldesleukin every 12 weeks during the maintenance period
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
Andre navn:
|
|
Placebo komparator: Blinded Maintenance Period: Placebo
Placebo every 4 weeks during the maintenance period
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
|
|
Eksperimentell: Open-Label Escape
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
|
Farmasøytisk form: Injeksjonsløsning Administrasjonsvei: subkutant
Andre navn:
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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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
Tidsramme: Week 0 and Week 24
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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
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
|
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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)
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 |
Tiltaksbeskrivelse |
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
|
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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
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
|
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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
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
|
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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
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
|
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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
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
|
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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
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
|
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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
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
|
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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
|
|
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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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
29. juni 2026
Primær fullføring (Antatt)
1. mai 2028
Studiet fullført (Antatt)
1. desember 2028
Datoer for studieregistrering
Først innsendt
2. juli 2026
Først innsendt som oppfylte QC-kriteriene
2. juli 2026
Først lagt ut (Faktiske)
8. juli 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
14. september 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
9. september 2026
Sist bekreftet
1. september 2026
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- 25-358-09
- 2025 (U.S. NIH-stipend/kontrakt: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-524925-42-00 (Ctis)
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
NEI
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Ja
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .