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Uno studio su Lebrikizumab in partecipanti adulti con rinite allergica perenne (PREPARED-1)

26 ottobre 2026 aggiornato da: Eli Lilly and Company

Uno studio di fase 3, multicentrico, randomizzato, in doppio cieco, controllato con placebo, a gruppi paralleli per valutare l'efficacia e la sicurezza di lebrikizumab/LY3650150 in partecipanti adulti con rinite allergica perenne

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.

Participants can expect study participation to last up to 29.5 months.

Panoramica dello studio

Stato

Attivo, non reclutante

Condizioni

Intervento / Trattamento

Tipo di studio

Interventistico

Iscrizione (Stimato)

450

Fase

  • Fase 3

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Luoghi di studio

  • Belgio
      • Brussels, Belgio, 1070
        • Hôpital Erasme, Service Pharmacie
      • Erpent, Belgio, 5101
        • Pneumocare
      • Ghent, Belgio, 9000
        • UZ Gent
      • Leuven, Belgio, 3000
        • UZ Leuven, Pharmacy
      • Liège, Belgio, 4000
        • Hôpital de la Citadelle
  • Cina
      • Beijing, Cina, 100032
        • Internal Medicine Building
      • Beijing, Cina, 100730
        • Department of Nasal Allergy
      • Changsha, Cina, 410013
        • The Third Xiangya Hospital of Central South University
      • Guangzhou, Cina, 510000
        • GCP Pharmacy
      • Hangzhou, Cina, 310014
        • Zhejiang People's Hospital
      • Jingzhou, Cina, 434020
        • Jingzhou Central Hospital
      • Nanchang, Cina, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Cina, 330006
        • The Second Affiliated Hospital of Nanchang University
      • Nanning, Cina, 530021
        • People's Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Cina, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai, Cina, 200065
        • Tongji Hospital
      • Wuhan, Cina, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Cina, 430014
        • Outpatient building
      • Wuhan, Cina, 430022
        • Outpatient Department, Union Hospital
      • Yangzhou, Cina, 225001
        • Northern Jiangsu People's Hospital
      • Yangzhou, Cina, 225012
        • Yangzhou University
      • Zhongshan, Cina, 528403
        • Zhongshan City People's Hospital
  • Corea del Sud
      • Busan, Corea del Sud, 48108
        • Inje University Haeundae Paik Hospital
      • Incheon, Corea del Sud, 21565
        • B1F, Pharmacy department, Gachon University Gil Medical Center
      • Seongnam-si, Corea del Sud, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sud, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Corea del Sud, 05278
        • Kyunghee University Hospital at Gangdong
      • Seoul, Corea del Sud, 6273
        • Gangnam Severance Hospital 211
      • Seoul, Corea del Sud, 7061
        • SMG-SNU Boramae Medical Center
      • Seoul, Corea del Sud, 8308
        • Clinical trial Pharmacy
  • Germania
      • Berlin, Germania, 10117
        • Charité - Universitätsmedizin Berlin Klinik für Dermatologie
      • Dresden, Germania, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Dresden, Germania, 1139
        • Praxis für HNO und Allergologie
      • Frankfurt am Main, Germania, 60596
        • IKF Pneumologie
      • Heidelberg, Germania, 69115
        • Siteworks - Zentrum für klinische Studien Heidelberg
      • Marburg, Germania, 35043
        • Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
      • Weisbaden, Germania, 65183
        • Zentrum für Rhinologie und Allergologie
  • Polonia
      • Kielce, Polonia, 25-355
        • Polimedica PTG Kielce
      • Krakow, Polonia, 31-513
        • Centrum Medyczne Promed ul. Olszańska 5G
      • Krakow, Polonia, 31-623
        • Malopolskie Centrum Alergologii
      • Lodz, Polonia, 90-302
        • gab. 114, ul. inż. pilota Wigury
      • Lublin, Polonia, 20-412
        • ETG Lublin
      • Piła, Polonia, 64-920
        • Centrum Alergologii Teresa Hofman Sp z.o.o.
      • Rzeszów, Polonia, 35-205
        • EMED Centrum Usług Medycznych
      • Skierniewice, Polonia, 96-100
        • ClinMedica Research
      • Tarnów, Polonia, 33-100
        • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
      • Warsaw, Polonia, 02-793
        • ETG Warszawa
      • Wroclaw, Polonia, 53-201
        • ALL-MED - Specjalistyczna Opieka Medyczna
  • Stati Uniti
    • California
      • Huntington Beach, California, Stati Uniti, 92648
        • Allergy and Asthma Specialists Medical Group
      • Inglewood, California, Stati Uniti, 90301
        • 310 Clinical Research
      • Laguna Niguel, California, Stati Uniti, 92677
        • Allergy & Asthma Associates of Southern California dba. Southern California Research
      • San Diego, California, Stati Uniti, 92123
        • Allergy and Asthma
    • Colorado
      • Colorado Springs, Colorado, Stati Uniti, 80907-6231
        • Asthma and Allergy Associates, PC
    • Florida
      • Tallahassee, Florida, Stati Uniti, 32308
        • Allergy and Asthma Diagnostic Center
      • Tampa, Florida, Stati Uniti, 33613
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Stati Uniti, 60611
        • Northwestern University
      • River Forest, Illinois, Stati Uniti, 60305
        • Asthma Allergy Center of Chicago
    • Kentucky
      • Lexington, Kentucky, Stati Uniti, 40509
        • Bluegrass Allergy Research
    • Michigan
      • Ypsilanti, Michigan, Stati Uniti, 48197
        • Respiratory Medicine Research Institute of Michigan, PLC
    • Minnesota
      • Minneapolis, Minnesota, Stati Uniti, 55402
        • Clinical Research Institute
    • Missouri
      • Columbia, Missouri, Stati Uniti, 65212
        • University of Missouri Hospital
      • St Louis, Missouri, Stati Uniti, 63141
        • Allergy and Asthma Consultants
    • Nebraska
      • Bellevue, Nebraska, Stati Uniti, 68123
        • Asthma and Allergy Center
    • New Jersey
      • Belleville, New Jersey, Stati Uniti, 07109
        • Circuit Clinical/Hudson-Essex Allergy
      • Hamilton, New Jersey, Stati Uniti, 08619
        • Circuit Clinical/Mercer Allergy and Pulmonary Associates
      • Teaneck, New Jersey, Stati Uniti, 07666
        • Dr. Patrick Perin
    • New York
      • Horseheads, New York, Stati Uniti, 14845
        • Smith Allergy and Asthma
    • North Carolina
      • Asheville, North Carolina, Stati Uniti, 28803
        • Allergy Partners
    • Ohio
      • Cincinnati, Ohio, Stati Uniti, 45236
        • Bernstein Clinical Research Center, LLC
    • Oregon
      • Portland, Oregon, Stati Uniti, 97202
        • Northwest Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Stati Uniti, 15241
        • Allergy and Clinical Immunology Associates
    • Texas
      • Dallas, Texas, Stati Uniti, 75231
        • AARA Research Center
      • Kerrville, Texas, Stati Uniti, 78028
        • Kerrville Allergy and Asthma Associates
    • Wisconsin
      • Greenfield, Wisconsin, Stati Uniti, 53228
        • Allergy, Asthma & Sinus Center

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

18 anni e precedenti (Adulto, Adulto più anziano)

Accetta volontari sani

No

Sessi ammissibili allo studio

Tutto

Descrizione

Inclusion Criteria:

  • Physician-diagnosed perennial allergic rhinitis (PAR).
  • Has a positive skin prick test (SPT) with indoor allergens and/or positive serum antigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
  • The participant must have clinical symptoms at study entry associated with positive perennial allergen as tested by the SPT or a positive serum antigen-specific IgE test.
  • A participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum antigen-specific IgE test.
  • Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.

Exclusion Criteria:

  • Have received a dose of lebrikizumab.

  • Is currently on AIT subcutaneous immunotherapy or sublingual immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy for ≥3 years prior to randomization are eligible.

  • Have received treatment with any rescue medication during the run-in period.

  • Have received treatment with any biologic or systemic immunosuppressants, including Janus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease prior to the baseline visit:

    • Any current or prior use of biologics indicated for asthma or AD are prohibited.
    • B cell-depleting biologics, including rituximab, within 6 months.
    • Other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
    • Systemic immunosuppressants, including JAK inhibitors, within 4 weeks prior to baseline.

  • Have a history of seasonal worsening of AR and if the seasonal worsening is expected during the 4-week run-in period, the first 16 weeks after randomization, or during the last 8 weeks of the maintenance period.

  • Anticipates significant changes in their daily environmental exposure.

  • Has a known history of recurrent acute or chronic sinusitis.

  • Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Doppio

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)

Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Droga: LY3650150

Administered SC

Droga: Standard therapy for INCS

Administered as intranasal spray
Sperimentale: Lebrikizumab Q2W/every 8 weeks (Q8W)

Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Droga: LY3650150

Administered SC

Droga: Standard therapy for INCS

Administered as intranasal spray
Comparatore placebo: Placebo Q2W/Q4W

Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Droga: Placebo

Administered SC

Droga: Standard therapy for INCS

Administered as intranasal spray

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Lasso di tempo: Baseline, Week 16

Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 16

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Lasso di tempo: Baseline, Week 16

The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 16
Mean CFBL in RQLQ(S) Activities Domain at Week 56
Lasso di tempo: Baseline, Week 56

The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment)
Baseline, Week 56
Mean CFBL in RQLQ(S) Total Score at Week 16
Lasso di tempo: Baseline, Week 16

The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 16
Mean CFBL in RQLQ(S) Total Score at Week 56
Lasso di tempo: Baseline, Week 56

The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).
Baseline, Week 56
Mean CFBL in TNSS at Week 4
Lasso di tempo: Baseline, Week 4

Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 4
Mean CFBL in TNSS at Week 56
Lasso di tempo: Baseline, Week 56

Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 56
Mean CFBL in Postnasal Drip Score at Week 16
Lasso di tempo: Baseline, Week 16

Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours.
Baseline, Week 16

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Eli Lilly and Company

Investigatori

  • Direttore dello studio: Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST), Eli Lilly and Company

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Effettivo)

26 aprile 2024

Completamento primario (Effettivo)

22 ottobre 2026

Completamento dello studio (Stimato)

1 ottobre 2028

Date di iscrizione allo studio

Primo inviato

25 marzo 2024

Primo inviato che soddisfa i criteri di controllo qualità

25 marzo 2024

Primo Inserito (Effettivo)

1 aprile 2024

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

27 ottobre 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

26 ottobre 2026

Ultimo verificato

1 ottobre 2026

Maggiori informazioni

Termini relativi a questo studio

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • 18789
  • J2T-MC-KGBT (Altro identificatore: Eli Lilly and Company)
  • 2023-508817-18-00 (Altro identificatore: EU Clinical Trial Number)
  • 2023 (Sovvenzione/contratto NIH degli Stati Uniti)

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

SÌ

Descrizione del piano IPD

Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.

Periodo di condivisione IPD

Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.

Criteri di accesso alla condivisione IPD

A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement

Tipo di informazioni di supporto alla condivisione IPD

  • STUDIO_PROTOCOLLO
  • LINFA
  • RSI

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

Sì

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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