Um estudo de lebrikizumabe em participantes adultos com rinite alérgica perene (PREPARED-1)
Um estudo de fase 3, multicêntrico, randomizado, duplo-cego, controlado por placebo, de grupo paralelo para avaliar a eficácia e segurança de lebrikizumabe/LY3650150 em participantes adultos com rinite alérgica perene
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.
Visão geral do estudo
Status
Condições
Intervenção / Tratamento
Tipo de estudo
Inscrição (Estimado)
Estágio
- Fase 3
Contactos e Locais
Locais de estudo
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Berlin, Alemanha, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, Alemanha, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, Alemanha, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, Alemanha, 60596
- IKF Pneumologie
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Heidelberg, Alemanha, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, Alemanha, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, Alemanha, 65183
- Zentrum für Rhinologie und Allergologie
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Brussels, Bélgica, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, Bélgica, 5101
- Pneumocare
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Ghent, Bélgica, 9000
- UZ Gent
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Leuven, Bélgica, 3000
- UZ Leuven, Pharmacy
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Liège, Bélgica, 4000
- Hôpital de la Citadelle
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Beijing, China, 100032
- Internal Medicine Building
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Beijing, China, 100730
- Department of Nasal Allergy
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Changsha, China, 410013
- The Third Xiangya Hospital of Central South University
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Guangzhou, China, 510000
- GCP Pharmacy
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Hangzhou, China, 310014
- Zhejiang People's Hospital
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Jingzhou, China, 434020
- Jingzhou Central Hospital
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Nanchang, China, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, China, 330006
- The Second Affiliated Hospital of Nanchang University
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Nanning, China, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, China, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, China, 200065
- Tongji Hospital
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Wuhan, China, 430060
- Renmin Hospital of Wuhan University
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Wuhan, China, 430014
- Outpatient building
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Wuhan, China, 430022
- Outpatient Department, Union Hospital
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Yangzhou, China, 225001
- Northern Jiangsu People's Hospital
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Yangzhou, China, 225012
- Yangzhou University
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Zhongshan, China, 528403
- Zhongshan City People's Hospital
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Busan, Coréia do Sul, 48108
- Inje University Haeundae Paik Hospital
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Incheon, Coréia do Sul, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, Coréia do Sul, 13620
- Seoul National University Bundang Hospital
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Seoul, Coréia do Sul, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Coréia do Sul, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, Coréia do Sul, 6273
- Gangnam Severance Hospital 211
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Seoul, Coréia do Sul, 7061
- SMG-SNU Boramae Medical Center
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Seoul, Coréia do Sul, 8308
- Clinical trial Pharmacy
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California
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Huntington Beach, California, Estados Unidos, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, Estados Unidos, 90301
- 310 Clinical Research
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Laguna Niguel, California, Estados Unidos, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, Estados Unidos, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, Estados Unidos, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, Estados Unidos, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, Estados Unidos, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, Estados Unidos, 60611
- Northwestern University
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River Forest, Illinois, Estados Unidos, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, Estados Unidos, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, Estados Unidos, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, Estados Unidos, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, Estados Unidos, 65212
- University of Missouri Hospital
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St Louis, Missouri, Estados Unidos, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, Estados Unidos, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, Estados Unidos, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, Estados Unidos, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, Estados Unidos, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, Estados Unidos, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, Estados Unidos, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, Estados Unidos, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, Estados Unidos, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Estados Unidos, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, Estados Unidos, 75231
- AARA Research Center
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Kerrville, Texas, Estados Unidos, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, Estados Unidos, 53228
- Allergy, Asthma & Sinus Center
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Kielce, Polônia, 25-355
- Polimedica PTG Kielce
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Krakow, Polônia, 31-513
- Centrum Medyczne Promed ul. Olszańska 5G
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Krakow, Polônia, 31-623
- Malopolskie Centrum Alergologii
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Lodz, Polônia, 90-302
- gab. 114, ul. inż. pilota Wigury
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Lublin, Polônia, 20-412
- ETG Lublin
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Piła, Polônia, 64-920
- Centrum Alergologii Teresa Hofman Sp z.o.o.
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Rzeszów, Polônia, 35-205
- EMED Centrum Usług Medycznych
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Skierniewice, Polônia, 96-100
- ClinMedica Research
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Tarnów, Polônia, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
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Warsaw, Polônia, 02-793
- ETG Warszawa
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Wroclaw, Polônia, 53-201
- ALL-MED - Specjalistyczna Opieka Medyczna
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Critérios de participação
Critérios de elegibilidade
Idades elegíveis para estudo
Aceita Voluntários Saudáveis
Gêneros Elegíveis para o Estudo
Descrição
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:
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Have received a dose of lebrikizumab.
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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.
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Have received treatment with any rescue medication during the run-in period.
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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.
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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.
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Anticipates significant changes in their daily environmental exposure.
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Has a known history of recurrent acute or chronic sinusitis.
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Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
Plano de estudo
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Dobro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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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). |
Administered SC Administered as intranasal spray |
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Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
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Comparador de Placebo: Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. |
Administered SC Administered as intranasal spray |
O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Prazo: Baseline, Week 16
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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
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Prazo: Baseline, Week 16
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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
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Mean CFBL in RQLQ(S) Activities Domain at Week 56
Prazo: Baseline, Week 56
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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
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Mean CFBL in RQLQ(S) Total Score at Week 16
Prazo: Baseline, Week 16
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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
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Mean CFBL in RQLQ(S) Total Score at Week 56
Prazo: Baseline, Week 56
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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
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Mean CFBL in TNSS at Week 4
Prazo: Baseline, Week 4
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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
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Mean CFBL in TNSS at Week 56
Prazo: Baseline, Week 56
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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
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Mean CFBL in Postnasal Drip Score at Week 16
Prazo: Baseline, Week 16
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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
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Colaboradores e Investigadores
Patrocinador
Investigadores
- Diretor de estudo: 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
Datas de registro do estudo
Datas Principais do Estudo
Início do estudo (Real)
Conclusão Primária (Real)
Conclusão do estudo (Estimado)
Datas de inscrição no estudo
Enviado pela primeira vez
Enviado pela primeira vez que atendeu aos critérios de CQ
Primeira postagem (Real)
Atualizações de registro de estudo
Última Atualização Postada (Real)
Última atualização enviada que atendeu aos critérios de controle de qualidade
Última verificação
Mais Informações
Termos relacionados a este estudo
Termos MeSH relevantes adicionais
- Doenças do sistema imunológico
- Doenças Respiratórias
- Hipersensibilidade Respiratória
- Hipersensibilidade, Imediata
- Hipersensibilidade
- Doenças do Nariz
- Doenças Otorrinolaringológicas
- Rinite
- Rinite Alérgica
- Rinite Alérgica Perene
- Administração de Serviços de Saúde
- Qualidade, acesso e avaliação da assistência médica
- Qualidade de assistência médica
- Indicadores de qualidade, assistência médica
- Padrão de atendimento
Outros números de identificação do estudo
- 18789
- J2T-MC-KGBT (Outro identificador: Eli Lilly and Company)
- 2023-508817-18-00 (Outro identificador: EU Clinical Trial Number)
- 2023 (Concessão/Contrato do NIH dos EUA)
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
Descrição do plano 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.
Prazo de Compartilhamento de 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.
Critérios de acesso de compartilhamento IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
Tipo de informação de suporte de compartilhamento de IPD
- PROTOCOLO DE ESTUDO
- SEIVA
- CSR
Informações sobre medicamentos e dispositivos, documentos de estudo
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