En studie av Lebrikizumab hos vuxna deltagare med perenn allergisk rinit (PREPARED-1)
En fas 3, multicenter, randomiserad, dubbelblind, placebokontrollerad, parallell gruppstudie för att utvärdera effektiviteten och säkerheten av Lebrikizumab/LY3650150 hos vuxna deltagare med perenn allergisk rinit
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.
Studieöversikt
Status
Betingelser
Intervention / Behandling
Studietyp
Inskrivning (Beräknad)
Fas
- Fas 3
Kontakter och platser
Studieorter
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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, Förenta staterna, 92648
- Allergy and Asthma Specialists Medical Group
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Inglewood, California, Förenta staterna, 90301
- 310 Clinical Research
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Laguna Niguel, California, Förenta staterna, 92677
- Allergy & Asthma Associates of Southern California dba. Southern California Research
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San Diego, California, Förenta staterna, 92123
- Allergy and Asthma
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Colorado
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Colorado Springs, Colorado, Förenta staterna, 80907-6231
- Asthma and Allergy Associates, PC
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Florida
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Tallahassee, Florida, Förenta staterna, 32308
- Allergy and Asthma Diagnostic Center
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Tampa, Florida, Förenta staterna, 33613
- University of South Florida
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Illinois
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Chicago, Illinois, Förenta staterna, 60611
- Northwestern University
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River Forest, Illinois, Förenta staterna, 60305
- Asthma Allergy Center of Chicago
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Kentucky
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Lexington, Kentucky, Förenta staterna, 40509
- Bluegrass Allergy Research
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Michigan
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Ypsilanti, Michigan, Förenta staterna, 48197
- Respiratory Medicine Research Institute of Michigan, PLC
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Minnesota
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Minneapolis, Minnesota, Förenta staterna, 55402
- Clinical Research Institute
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Missouri
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Columbia, Missouri, Förenta staterna, 65212
- University of Missouri Hospital
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St Louis, Missouri, Förenta staterna, 63141
- Allergy and Asthma Consultants
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Nebraska
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Bellevue, Nebraska, Förenta staterna, 68123
- Asthma and Allergy Center
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New Jersey
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Belleville, New Jersey, Förenta staterna, 07109
- Circuit Clinical/Hudson-Essex Allergy
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Hamilton, New Jersey, Förenta staterna, 08619
- Circuit Clinical/Mercer Allergy and Pulmonary Associates
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Teaneck, New Jersey, Förenta staterna, 07666
- Dr. Patrick Perin
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New York
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Horseheads, New York, Förenta staterna, 14845
- Smith Allergy and Asthma
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North Carolina
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Asheville, North Carolina, Förenta staterna, 28803
- Allergy Partners
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Ohio
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Cincinnati, Ohio, Förenta staterna, 45236
- Bernstein Clinical Research Center, LLC
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Oregon
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Portland, Oregon, Förenta staterna, 97202
- Northwest Research Center
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Pennsylvania
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Pittsburgh, Pennsylvania, Förenta staterna, 15241
- Allergy and Clinical Immunology Associates
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Texas
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Dallas, Texas, Förenta staterna, 75231
- AARA Research Center
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Kerrville, Texas, Förenta staterna, 78028
- Kerrville Allergy and Asthma Associates
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Wisconsin
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Greenfield, Wisconsin, Förenta staterna, 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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Deltagandekriterier
Urvalskriterier
Åldrar som är berättigade till studier
Tar emot friska volontärer
Kön som är behöriga för studier
Beskrivning
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
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Dubbel
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
|---|---|
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Experimentell: 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 |
|
Experimentell: 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-jämförare: 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 |
Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Tidsram: 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
|
Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
|
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
|
Samarbetspartners och utredare
Sponsor
Utredare
- Studierektor: 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
Studieavstämningsdatum
Studera stora datum
Studiestart (Faktisk)
Primärt slutförande (Faktisk)
Avslutad studie (Beräknad)
Studieregistreringsdatum
Först inskickad
Först inskickad som uppfyllde QC-kriterierna
Första postat (Faktisk)
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
Senast verifierad
Mer information
Termer relaterade till denna studie
Ytterligare relevanta MeSH-villkor
- Immunsystemets sjukdomar
- Luftvägssjukdomar
- Respiratorisk överkänslighet
- Överkänslighet, Omedelbar
- Överkänslighet
- Nässjukdomar
- Otorhinolaryngologiska sjukdomar
- Rhinit
- Rhinit, Allergisk
- Rhinit, Allergisk, Perenn
- Administration
- Sjukvårdskvalitet, tillgång och utvärdering
- Hälsovårdskvalitet
- Kvalitetsindikatorer, hälsovård
- Vårdstandard
Andra studie-ID-nummer
- 18789
- J2T-MC-KGBT (Annan identifierare: Eli Lilly and Company)
- 2023-508817-18-00 (Annan identifierare: EU Clinical Trial Number)
- 2023 (U.S.S. NIH-anslag/kontrakt)
Plan för individuella deltagardata (IPD)
Planerar du att dela individuella deltagardata (IPD)?
IPD-planbeskrivning
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.
Tidsram för IPD-delning
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.
Kriterier för IPD Sharing Access
A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
IPD-delning som stöder informationstyp
- STUDY_PROTOCOL
- SAV
- CSR
Läkemedels- och apparatinformation, studiedokument
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