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Un estudio de lebrikizumab en participantes adultos con rinitis alérgica perenne (PREPARED-1)

26 de octubre de 2026 actualizado por: Eli Lilly and Company

Un estudio de fase 3, multicéntrico, aleatorizado, doble ciego, controlado con placebo y de grupos paralelos para evaluar la eficacia y seguridad de lebrikizumab/LY3650150 en participantes adultos con rinitis alérgica 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.

Descripción general del estudio

Estado

Activo, no reclutando

Condiciones

Intervención / Tratamiento

Tipo de estudio

Intervencionista

Inscripción (Estimado)

450

Fase

  • Fase 3

Contactos y Ubicaciones

Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.

Ubicaciones de estudio

  • Alemania
      • Berlin, Alemania, 10117
        • Charité - Universitätsmedizin Berlin Klinik für Dermatologie
      • Dresden, Alemania, 1307
        • Universitätsklinikum Carl Gustav Carus an der TU
      • Dresden, Alemania, 1139
        • Praxis für HNO und Allergologie
      • Frankfurt am Main, Alemania, 60596
        • IKF Pneumologie
      • Heidelberg, Alemania, 69115
        • Siteworks - Zentrum für klinische Studien Heidelberg
      • Marburg, Alemania, 35043
        • Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
      • Weisbaden, Alemania, 65183
        • Zentrum für Rhinologie und Allergologie
  • Bélgica
      • Brussels, Bélgica, 1070
        • Hôpital Erasme, Service Pharmacie
      • Erpent, Bélgica, 5101
        • Pneumocare
      • Ghent, Bélgica, 9000
        • UZ Gent
      • Leuven, Bélgica, 3000
        • UZ Leuven, Pharmacy
      • Liège, Bélgica, 4000
        • Hôpital de la Citadelle
  • Corea del Sur
      • Busan, Corea del Sur, 48108
        • Inje University Haeundae Paik Hospital
      • Incheon, Corea del Sur, 21565
        • B1F, Pharmacy department, Gachon University Gil Medical Center
      • Seongnam-si, Corea del Sur, 13620
        • Seoul National University Bundang Hospital
      • Seoul, Corea del Sur, 03722
        • Severance Hospital, Yonsei University Health System
      • Seoul, Corea del Sur, 05278
        • Kyunghee University Hospital at Gangdong
      • Seoul, Corea del Sur, 6273
        • Gangnam Severance Hospital 211
      • Seoul, Corea del Sur, 7061
        • SMG-SNU Boramae Medical Center
      • Seoul, Corea del Sur, 8308
        • Clinical trial Pharmacy
  • Estados Unidos
    • California
      • Huntington Beach, California, Estados Unidos, 92648
        • Allergy and Asthma Specialists Medical Group
      • Inglewood, California, Estados Unidos, 90301
        • 310 Clinical Research
      • Laguna Niguel, California, Estados Unidos, 92677
        • Allergy & Asthma Associates of Southern California dba. Southern California Research
      • San Diego, California, Estados Unidos, 92123
        • Allergy and Asthma
    • Colorado
      • Colorado Springs, Colorado, Estados Unidos, 80907-6231
        • Asthma and Allergy Associates, PC
    • Florida
      • Tallahassee, Florida, Estados Unidos, 32308
        • Allergy and Asthma Diagnostic Center
      • Tampa, Florida, Estados Unidos, 33613
        • University of South Florida
    • Illinois
      • Chicago, Illinois, Estados Unidos, 60611
        • Northwestern University
      • River Forest, Illinois, Estados Unidos, 60305
        • Asthma Allergy Center of Chicago
    • Kentucky
      • Lexington, Kentucky, Estados Unidos, 40509
        • Bluegrass Allergy Research
    • Michigan
      • Ypsilanti, Michigan, Estados Unidos, 48197
        • Respiratory Medicine Research Institute of Michigan, PLC
    • Minnesota
      • Minneapolis, Minnesota, Estados Unidos, 55402
        • Clinical Research Institute
    • Missouri
      • Columbia, Missouri, Estados Unidos, 65212
        • University of Missouri Hospital
      • St Louis, Missouri, Estados Unidos, 63141
        • Allergy and Asthma Consultants
    • Nebraska
      • Bellevue, Nebraska, Estados Unidos, 68123
        • Asthma and Allergy Center
    • New Jersey
      • Belleville, New Jersey, Estados Unidos, 07109
        • Circuit Clinical/Hudson-Essex Allergy
      • Hamilton, New Jersey, Estados Unidos, 08619
        • Circuit Clinical/Mercer Allergy and Pulmonary Associates
      • Teaneck, New Jersey, Estados Unidos, 07666
        • Dr. Patrick Perin
    • New York
      • Horseheads, New York, Estados Unidos, 14845
        • Smith Allergy and Asthma
    • North Carolina
      • Asheville, North Carolina, Estados Unidos, 28803
        • Allergy Partners
    • Ohio
      • Cincinnati, Ohio, Estados Unidos, 45236
        • Bernstein Clinical Research Center, LLC
    • Oregon
      • Portland, Oregon, Estados Unidos, 97202
        • Northwest Research Center
    • Pennsylvania
      • Pittsburgh, Pennsylvania, Estados Unidos, 15241
        • Allergy and Clinical Immunology Associates
    • Texas
      • Dallas, Texas, Estados Unidos, 75231
        • AARA Research Center
      • Kerrville, Texas, Estados Unidos, 78028
        • Kerrville Allergy and Asthma Associates
    • Wisconsin
      • Greenfield, Wisconsin, Estados Unidos, 53228
        • Allergy, Asthma & Sinus Center
  • 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
  • Porcelana
      • Beijing, Porcelana, 100032
        • Internal Medicine Building
      • Beijing, Porcelana, 100730
        • Department of Nasal Allergy
      • Changsha, Porcelana, 410013
        • The Third Xiangya Hospital of Central South University
      • Guangzhou, Porcelana, 510000
        • GCP Pharmacy
      • Hangzhou, Porcelana, 310014
        • Zhejiang People's Hospital
      • Jingzhou, Porcelana, 434020
        • Jingzhou Central Hospital
      • Nanchang, Porcelana, 330006
        • The First Affiliated Hospital of Nanchang University
      • Nanchang, Porcelana, 330006
        • The Second Affiliated Hospital of Nanchang University
      • Nanning, Porcelana, 530021
        • People's Hospital of Guangxi Zhuang Autonomous Region
      • Nanning, Porcelana, 530021
        • The First Affiliated Hospital of Guangxi Medical University
      • Shanghai, Porcelana, 200065
        • Tongji Hospital
      • Wuhan, Porcelana, 430060
        • Renmin Hospital of Wuhan University
      • Wuhan, Porcelana, 430014
        • Outpatient building
      • Wuhan, Porcelana, 430022
        • Outpatient Department, Union Hospital
      • Yangzhou, Porcelana, 225001
        • Northern Jiangsu People's Hospital
      • Yangzhou, Porcelana, 225012
        • Yangzhou University
      • Zhongshan, Porcelana, 528403
        • Zhongshan City People's Hospital

Criterios de participación

Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.

Criterio de elegibilidad

Edades elegibles para estudiar

18 años y mayores (Adulto, Adulto Mayor)

Acepta Voluntarios Saludables

No

Géneros elegibles para el estudio

Todos

Descripción

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.

Plan de estudios

Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.

¿Cómo está diseñado el estudio?

Detalles de diseño

  • Propósito principal: Tratamiento
  • Asignación: Aleatorizado
  • Modelo Intervencionista: Asignación paralela
  • Enmascaramiento: Doble

Armas e Intervenciones

Grupo de participantes/brazo
Intervención / Tratamiento
Experimental: 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
Experimental: 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
Comparador de placebos: 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

¿Qué mide el estudio?

Medidas de resultado primarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Periodo de tiempo: 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

Medidas de resultado secundarias

Medida de resultado
Medida Descripción
Periodo de tiempo
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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

Colaboradores e Investigadores

Aquí es donde encontrará personas y organizaciones involucradas en este estudio.

Patrocinador

Eli Lilly and Company

Investigadores

  • Director de estudio: 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

Fechas de registro del estudio

Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados ​​por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.

Fechas importantes del estudio

Inicio del estudio (Actual)

26 de abril de 2024

Finalización primaria (Actual)

22 de octubre de 2026

Finalización del estudio (Estimado)

1 de octubre de 2028

Fechas de registro del estudio

Enviado por primera vez

25 de marzo de 2024

Primero enviado que cumplió con los criterios de control de calidad

25 de marzo de 2024

Publicado por primera vez (Actual)

1 de abril de 2024

Actualizaciones de registros de estudio

Última actualización publicada (Actual)

27 de octubre de 2026

Última actualización enviada que cumplió con los criterios de control de calidad

26 de octubre de 2026

Última verificación

1 de octubre de 2026

Más información

Términos relacionados con este estudio

Términos MeSH relevantes adicionales

Otros números de identificación del estudio

  • 18789
  • J2T-MC-KGBT (Otro identificador: Eli Lilly and Company)
  • 2023-508817-18-00 (Otro identificador: EU Clinical Trial Number)
  • 2023 (Subvención/contrato del NIH de EE. UU.)

Plan de datos de participantes individuales (IPD)

¿Planea compartir datos de participantes individuales (IPD)?

SÍ

Descripción del plan 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.

Marco de tiempo para compartir 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.

Criterios de acceso compartido de IPD

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

Tipo de información de apoyo para compartir IPD

  • PROTOCOLO DE ESTUDIO
  • SAVIA
  • RSC

Información sobre medicamentos y dispositivos, documentos del estudio

Estudia un producto farmacéutico regulado por la FDA de EE. UU.

Sí

Estudia un producto de dispositivo regulado por la FDA de EE. UU.

No

Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .

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