Een onderzoek naar lebrikizumab bij volwassen deelnemers met niet-seizoensgebonden allergische rhinitis (PREPARED-1)
Een fase 3, multicenter, gerandomiseerde, dubbelblinde, placebogecontroleerde, parallelle groepsstudie om de werkzaamheid en veiligheid van Lebrikizumab/LY3650150 te evalueren bij volwassen deelnemers met niet-seizoensgebonden allergische rhinitis
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.
Studie Overzicht
Toestand
Interventie / Behandeling
Studietype
Inschrijving (Geschat)
Fase
- Fase 3
Contacten en locaties
Studie Locaties
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Brussels, België, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, België, 5101
- Pneumocare
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Ghent, België, 9000
- UZ Gent
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Leuven, België, 3000
- UZ Leuven, Pharmacy
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Liège, België, 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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Berlin, Duitsland, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, Duitsland, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, Duitsland, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, Duitsland, 60596
- IKF Pneumologie
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Heidelberg, Duitsland, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, Duitsland, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, Duitsland, 65183
- Zentrum für Rhinologie und Allergologie
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Kielce, Polen, 25-355
- Polimedica PTG Kielce
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Krakow, Polen, 31-513
- Centrum Medyczne Promed ul. Olszańska 5G
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Krakow, Polen, 31-623
- Malopolskie Centrum Alergologii
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Lodz, Polen, 90-302
- gab. 114, ul. inż. pilota Wigury
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Lublin, Polen, 20-412
- ETG Lublin
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Piła, Polen, 64-920
- Centrum Alergologii Teresa Hofman Sp z.o.o.
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Rzeszów, Polen, 35-205
- EMED Centrum Usług Medycznych
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Skierniewice, Polen, 96-100
- ClinMedica Research
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Tarnów, Polen, 33-100
- Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
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Warsaw, Polen, 02-793
- ETG Warszawa
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Wroclaw, Polen, 53-201
- ALL-MED - Specjalistyczna Opieka Medyczna
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California
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Huntington Beach, California, Verenigde Staten, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, Verenigde Staten, 90301
- 310 Clinical Research
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Laguna Niguel, California, Verenigde Staten, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, Verenigde Staten, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, Verenigde Staten, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, Verenigde Staten, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, Verenigde Staten, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, Verenigde Staten, 60611
- Northwestern University
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River Forest, Illinois, Verenigde Staten, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, Verenigde Staten, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, Verenigde Staten, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, Verenigde Staten, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, Verenigde Staten, 65212
- University of Missouri Hospital
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St Louis, Missouri, Verenigde Staten, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, Verenigde Staten, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, Verenigde Staten, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, Verenigde Staten, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, Verenigde Staten, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, Verenigde Staten, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, Verenigde Staten, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, Verenigde Staten, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, Verenigde Staten, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Verenigde Staten, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, Verenigde Staten, 75231
- AARA Research Center
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Kerrville, Texas, Verenigde Staten, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, Verenigde Staten, 53228
- Allergy, Asthma & Sinus Center
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Busan, Zuid -Korea, 48108
- Inje University Haeundae Paik Hospital
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Incheon, Zuid -Korea, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, Zuid -Korea, 13620
- Seoul National University Bundang Hospital
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Seoul, Zuid -Korea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Zuid -Korea, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, Zuid -Korea, 6273
- Gangnam Severance Hospital 211
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Seoul, Zuid -Korea, 7061
- SMG-SNU Boramae Medical Center
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Seoul, Zuid -Korea, 8308
- Clinical trial Pharmacy
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Deelname Criteria
Geschiktheidscriteria
Leeftijden die in aanmerking komen voor studie
Accepteert gezonde vrijwilligers
Geslachten die in aanmerking komen voor studie
Beschrijving
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.
Studie plan
Hoe is de studie opgezet?
Ontwerpdetails
- Primair doel: Behandeling
- Toewijzing: Gerandomiseerd
- Interventioneel model: Parallelle opdracht
- Masker: Dubbele
Wapens en interventies
Deelnemersgroep / Arm |
Interventie / Behandeling |
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Experimenteel: 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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Experimenteel: 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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Placebo-vergelijker: 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 |
Wat meet het onderzoek?
Primaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Tijdsspanne: 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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Secundaire uitkomstmaten
Uitkomstmaat |
Maatregel Beschrijving |
Tijdsspanne |
|---|---|---|
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Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Tijdsspanne: 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
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Mean CFBL in RQLQ(S) Activities Domain at Week 56
Tijdsspanne: 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
Tijdsspanne: 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
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Mean CFBL in RQLQ(S) Total Score at Week 56
Tijdsspanne: 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
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Mean CFBL in TNSS at Week 4
Tijdsspanne: 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
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Mean CFBL in TNSS at Week 56
Tijdsspanne: 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
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Mean CFBL in Postnasal Drip Score at Week 16
Tijdsspanne: 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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Medewerkers en onderzoekers
Sponsor
Onderzoekers
- Studie directeur: 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
Studie record data
Bestudeer belangrijke data
Studie start (Werkelijk)
Primaire voltooiing (Werkelijk)
Studie voltooiing (Geschat)
Studieregistratiedata
Eerst ingediend
Eerst ingediend dat voldeed aan de QC-criteria
Eerst geplaatst (Werkelijk)
Updates van studierecords
Laatste update geplaatst (Werkelijk)
Laatste update ingediend die voldeed aan QC-criteria
Laatst geverifieerd
Meer informatie
Termen gerelateerd aan deze studie
Aanvullende relevante MeSH-voorwaarden
- Ziekten van het immuunsysteem
- Ziekten van de luchtwegen
- Ademhalingsovergevoeligheid
- Overgevoeligheid, Onmiddellijk
- Overgevoeligheid
- Neus Ziekten
- KNO-ziekten
- Rhinitis
- Rhinitis, Allergisch
- Rhinitis, allergisch, meerjarig
- Health Services Administration
- Kwaliteit, toegang en evaluatie van de gezondheidszorg
- Kwaliteit van de gezondheidszorg
- Kwaliteitsindicatoren, gezondheidszorg
- Zorgstandaard
Andere studie-ID-nummers
- 18789
- J2T-MC-KGBT (Andere identificatie: Eli Lilly and Company)
- 2023-508817-18-00 (Andere identificatie: EU Clinical Trial Number)
- 2023 (Subsidie/contract van de Amerikaanse NIH)
Plan Individuele Deelnemersgegevens (IPD)
Bent u van plan om gegevens van individuele deelnemers (IPD) te delen?
Beschrijving IPD-plan
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.
IPD-tijdsbestek voor delen
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.
IPD-toegangscriteria voor delen
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD delen Ondersteunend informatietype
- LEERPROTOCOOL
- SAP
- MVO
Informatie over medicijnen en apparaten, studiedocumenten
Bestudeert een door de Amerikaanse FDA gereguleerd geneesmiddel
Bestudeert een door de Amerikaanse FDA gereguleerd apparaatproduct
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