En undersøgelse af Lebrikizumab hos voksne deltagere med flerårig allergisk rhinitis (PREPARED-1)
En fase 3, multicenter, randomiseret, dobbeltblind, placebokontrolleret, parallel gruppeundersøgelse til evaluering af effektiviteten og sikkerheden af Lebrikizumab/LY3650150 hos voksne deltagere med flerårig allergisk 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.
Studieoversigt
Status
Betingelser
Intervention / Behandling
Undersøgelsestype
Tilmelding (Anslået)
Fase
- Fase 3
Kontakter og lokationer
Studiesteder
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Brussels, Belgien, 1070
- Hôpital Erasme, Service Pharmacie
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Erpent, Belgien, 5101
- Pneumocare
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Ghent, Belgien, 9000
- UZ Gent
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Leuven, Belgien, 3000
- UZ Leuven, Pharmacy
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Liège, Belgien, 4000
- Hôpital de la Citadelle
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California
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Huntington Beach, California, Forenede Stater, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, Forenede Stater, 90301
- 310 Clinical Research
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Laguna Niguel, California, Forenede Stater, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, Forenede Stater, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, Forenede Stater, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, Forenede Stater, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, Forenede Stater, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, Forenede Stater, 60611
- Northwestern University
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River Forest, Illinois, Forenede Stater, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, Forenede Stater, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, Forenede Stater, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, Forenede Stater, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, Forenede Stater, 65212
- University of Missouri Hospital
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St Louis, Missouri, Forenede Stater, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, Forenede Stater, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, Forenede Stater, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, Forenede Stater, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, Forenede Stater, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, Forenede Stater, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, Forenede Stater, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, Forenede Stater, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, Forenede Stater, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Forenede Stater, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, Forenede Stater, 75231
- AARA Research Center
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Kerrville, Texas, Forenede Stater, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, Forenede Stater, 53228
- Allergy, Asthma & Sinus Center
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Beijing, Kina, 100032
- Internal Medicine Building
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Beijing, Kina, 100730
- Department of Nasal Allergy
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Changsha, Kina, 410013
- The Third Xiangya Hospital of Central South University
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Guangzhou, Kina, 510000
- GCP Pharmacy
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Hangzhou, Kina, 310014
- Zhejiang People's Hospital
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Jingzhou, Kina, 434020
- Jingzhou Central Hospital
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Nanchang, Kina, 330006
- The First Affiliated Hospital of Nanchang University
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Nanchang, Kina, 330006
- The Second Affiliated Hospital of Nanchang University
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Nanning, Kina, 530021
- People's Hospital of Guangxi Zhuang Autonomous Region
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Nanning, Kina, 530021
- The First Affiliated Hospital of Guangxi Medical University
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Shanghai, Kina, 200065
- Tongji Hospital
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Wuhan, Kina, 430060
- Renmin Hospital of Wuhan University
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Wuhan, Kina, 430014
- Outpatient building
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Wuhan, Kina, 430022
- Outpatient Department, Union Hospital
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Yangzhou, Kina, 225001
- Northern Jiangsu People's Hospital
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Yangzhou, Kina, 225012
- Yangzhou University
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Zhongshan, Kina, 528403
- Zhongshan City People's Hospital
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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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Busan, Sydkorea, 48108
- Inje University Haeundae Paik Hospital
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Incheon, Sydkorea, 21565
- B1F, Pharmacy department, Gachon University Gil Medical Center
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Seongnam-si, Sydkorea, 13620
- Seoul National University Bundang Hospital
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Seoul, Sydkorea, 03722
- Severance Hospital, Yonsei University Health System
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Seoul, Sydkorea, 05278
- Kyunghee University Hospital at Gangdong
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Seoul, Sydkorea, 6273
- Gangnam Severance Hospital 211
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Seoul, Sydkorea, 7061
- SMG-SNU Boramae Medical Center
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Seoul, Sydkorea, 8308
- Clinical trial Pharmacy
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Berlin, Tyskland, 10117
- Charité - Universitätsmedizin Berlin Klinik für Dermatologie
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Dresden, Tyskland, 1307
- Universitätsklinikum Carl Gustav Carus an der TU
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Dresden, Tyskland, 1139
- Praxis für HNO und Allergologie
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Frankfurt am Main, Tyskland, 60596
- IKF Pneumologie
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Heidelberg, Tyskland, 69115
- Siteworks - Zentrum für klinische Studien Heidelberg
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Marburg, Tyskland, 35043
- Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
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Weisbaden, Tyskland, 65183
- Zentrum für Rhinologie und Allergologie
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Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
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.
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
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Eksperimentel: 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 |
|
Eksperimentel: 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 |
|
Placebo komparator: 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 |
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Tidsramme: 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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Tidsramme: 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
Tidsramme: 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 RQLQ(S) Total Score at Week 16
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
Tidsramme: 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
|
Samarbejdspartnere og efterforskere
Sponsor
Efterforskere
- Studieleder: 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
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Anslået)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
- Sygdomme i immunsystemet
- Luftvejssygdomme
- Respiratorisk overfølsomhed
- Overfølsomhed, Øjeblikkelig
- Overfølsomhed
- Næsesygdomme
- Otorhinolaryngologiske sygdomme
- Rhinitis
- Rhinitis, Allergisk
- Rhinitis, Allergisk, Flerårig
- Sundhedstjenester Administration
- Sundhedsvæsenets kvalitet, adgang og evaluering
- Sundhedskvalitet
- Kvalitetsindikatorer, sundhedsvæsenet
- Standard for pleje
Andre undersøgelses-id-numre
- 18789
- J2T-MC-KGBT (Anden identifikator: Eli Lilly and Company)
- 2023-508817-18-00 (Anden identifikator: EU Clinical Trial Number)
- 2023 (U.S. NIH-bevilling/kontrakt)
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
IPD-planbeskrivelse
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-delingstidsramme
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-delingsadgangskriterier
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD-deling Understøttende informationstype
- STUDY_PROTOCOL
- SAP
- CSR
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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