Une étude sur le lebrikizumab chez des participants adultes atteints de rhinite allergique perannuelle (PREPARED-1)
Une étude de phase 3, multicentrique, randomisée, en double aveugle, contrôlée par placebo, en groupe parallèle pour évaluer l'efficacité et l'innocuité du lebrikizumab/LY3650150 chez des participants adultes atteints de rhinite allergique pérenne
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.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Estimé)
Phase
- Phase 3
Contacts et emplacements
Lieux d'étude
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Berlin, Allemagne, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, Allemagne, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, Allemagne, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, Allemagne, 60596
- IKF Pneumologie
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Heidelberg, Allemagne, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, Allemagne, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, Allemagne, 65183
- Zentrum für Rhinologie und Allergologie
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Brussels, Belgique, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, Belgique, 5101
- Pneumocare
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Ghent, Belgique, 9000
- UZ Gent
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Leuven, Belgique, 3000
- UZ Leuven, Pharmacy
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Liège, Belgique, 4000
- Hôpital de la Citadelle
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Beijing, Chine, 100032
- Internal Medicine Building
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Beijing, Chine, 100730
- Department of Nasal Allergy
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Changsha, Chine, 410013
- The Third Xiangya Hospital of Central South University
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Guangzhou, Chine, 510000
- GCP Pharmacy
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Hangzhou, Chine, 310014
- Zhejiang People's Hospital
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Jingzhou, Chine, 434020
- Jingzhou Central Hospital
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Nanchang, Chine, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Chine, 330006
- The Second Affiliated Hospital of Nanchang University
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Nanning, Chine, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Chine, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Chine, 200065
- Tongji Hospital
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Wuhan, Chine, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Chine, 430014
- Outpatient building
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Wuhan, Chine, 430022
- Outpatient Department, Union Hospital
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Yangzhou, Chine, 225001
- Northern Jiangsu People's Hospital
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Yangzhou, Chine, 225012
- Yangzhou University
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Zhongshan, Chine, 528403
- Zhongshan City People's Hospital
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Busan, Corée du Sud, 48108
- Inje University Haeundae Paik Hospital
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Incheon, Corée du Sud, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, Corée du Sud, 13620
- Seoul National University Bundang Hospital
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Seoul, Corée du Sud, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Corée du Sud, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, Corée du Sud, 6273
- Gangnam Severance Hospital 211
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Seoul, Corée du Sud, 7061
- SMG-SNU Boramae Medical Center
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Seoul, Corée du Sud, 8308
- Clinical trial Pharmacy
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Kielce, Pologne, 25-355
- Polimedica PTG Kielce
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Krakow, Pologne, 31-513
- Centrum Medyczne Promed ul. Olszańska 5G
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Krakow, Pologne, 31-623
- Malopolskie Centrum Alergologii
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Lodz, Pologne, 90-302
- gab. 114, ul. inż. pilota Wigury
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Lublin, Pologne, 20-412
- ETG Lublin
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Piła, Pologne, 64-920
- Centrum Alergologii Teresa Hofman Sp z.o.o.
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Rzeszów, Pologne, 35-205
- EMED Centrum Usług Medycznych
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Skierniewice, Pologne, 96-100
- ClinMedica Research
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Tarnów, Pologne, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
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Warsaw, Pologne, 02-793
- ETG Warszawa
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Wroclaw, Pologne, 53-201
- ALL-MED - Specjalistyczna Opieka Medyczna
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California
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Huntington Beach, California, États-Unis, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, États-Unis, 90301
- 310 Clinical Research
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Laguna Niguel, California, États-Unis, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, États-Unis, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, États-Unis, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, États-Unis, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, États-Unis, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, États-Unis, 60611
- Northwestern University
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River Forest, Illinois, États-Unis, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, États-Unis, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, États-Unis, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, États-Unis, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, États-Unis, 65212
- University of Missouri Hospital
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St Louis, Missouri, États-Unis, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, États-Unis, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, États-Unis, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, États-Unis, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, États-Unis, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, États-Unis, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, États-Unis, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, États-Unis, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, États-Unis, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, États-Unis, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, États-Unis, 75231
- AARA Research Center
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Kerrville, Texas, États-Unis, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, États-Unis, 53228
- Allergy, Asthma & Sinus Center
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Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
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.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Double
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
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Expérimental: 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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Expérimental: 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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Comparateur 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 |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Délai: 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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
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Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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
Délai: 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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Collaborateurs et enquêteurs
Parrainer
Les enquêteurs
- Directeur d'études: 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
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude (Réel)
Achèvement primaire (Réel)
Achèvement de l'étude (Estimé)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Réel)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système immunitaire
- Maladies des voies respiratoires
- Hypersensibilité respiratoire
- Hypersensibilité immédiate
- Hypersensibilité
- Maladies du nez
- Maladies oto-rhino-laryngologiques
- Rhinite
- Rhinite allergique
- Rhinite, allergique, pérenne
- Administration des services de santé
- Qualité des soins de santé, accès et évaluation
- Qualité des soins de santé
- Indicateurs de qualité, soins de santé
- Standard de soins
Autres numéros d'identification d'étude
- 18789
- J2T-MC-KGBT (Autre identifiant: Eli Lilly and Company)
- 2023-508817-18-00 (Autre identifiant: EU Clinical Trial Number)
- 2023 (Subvention/contrat des NIH des États-Unis)
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
Description du régime 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.
Délai de partage 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.
Critères d'accès au partage IPD
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
Type d'informations de prise en charge du partage d'IPD
- PROTOCOLE D'ÉTUDE
- SÈVE
- RSE
Informations sur les médicaments et les dispositifs, documents d'étude
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