A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
- Conditions
- Perennial Allergic Rhinitis (PAR)
- Interventions
- Registration Number
- NCT06339008
- Lead Sponsor
- Eli Lilly and Company
- Brief Summary
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 450
- Physician-diagnosed PAR.
- Has a positive skin prick test (SPT) with indoor allergens and/or positive antigen-specific serum immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
- A dermatographic participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum IgE test.
- Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
-
Have received a dose of lebrikizumab.
-
Is currently on allergen immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy (SCIT/SLIT) for ≥3 years prior to randomization are eligible, if they were not on a maintenance allergen immunotherapy (AIT) regimen.
-
Have received treatment with any rescue medication during the screening and/or run-in period.
-
Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
- 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 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 4 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lebrikizumab Q2W/every 8 weeks (Q8W) LY3650150 Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. Lebrikizumab Q2W/every 8 weeks (Q8W) Standard therapy for INCS Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) Standard therapy for INCS Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) LY3650150 Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Placebo Q2W/Q4W Placebo Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. Placebo Q2W/Q4W Standard therapy for INCS Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
- Primary Outcome Measures
Name Time Method Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at week 16 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.
- Secondary Outcome Measures
Name Time Method Mean CFBL in RQLQ(S) at week 56 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)
Mean CFBL in TNSS at Week 4 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.
Mean CFBL in TNSS at Week 56 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.
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] at week 16 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).
Mean CFBL in Postnasal drip score at Week 16 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.
Trial Locations
- Locations (64)
Clinical trial Pharmacy
🇰🇷Seoul, Korea, Republic of
Polimedica PTG Kielce
🇵🇱Kielce, Poland
Centrum Medyczne Promed ul. Olszańska 5G
🇵🇱Krakow, Poland
gab. 114, ul. inż. pilota Wigury
🇵🇱Lodz, Poland
Department of Nasal Allergy
🇨🇳Beijing, China
GCP Pharmacy
🇨🇳Guangzhou City, China
ETG Lublin
🇵🇱Lublin, Poland
Outpatient building
🇨🇳Wuhan City, China
Allergy and Asthma Specialists Medical Group
🇺🇸Huntington Beach, California, United States
310 Clinical Research
🇺🇸Inglewood, California, United States
Allergy & Asthma Associates of Southern California dba. Southern California Research
🇺🇸Laguna Niguel, California, United States
Allergy and Asthma
🇺🇸San Diego, California, United States
Asthma and Allergy Associates, PC
🇺🇸Colorado Springs, Colorado, United States
University of South Florida
🇺🇸Tampa, Florida, United States
Asthma Allergy Center of Chicago
🇺🇸Chicago, Illinois, United States
Respiratory Medicine Research Institute of Michigan, PLC
🇺🇸Ypsilanti, Michigan, United States
Clinical Research Institute
🇺🇸Minneapolis, Minnesota, United States
Allergy, Asthma & Sinus Center
🇺🇸Greenfield, Wisconsin, United States
Hôpital Erasme, Service Pharmacie
🇧🇪Brussels, Belgium
Zhejiang People's Hospital
🇨🇳Hangzhou City, China
Outpatient Department, Union Hospital
🇨🇳Wuhan, China
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
🇩🇪Berlin, Germany
Praxis für HNO und Allergologie
🇩🇪Dresden, Germany
Kyunghee University Hospital at Gangdong
🇰🇷Seoul, Seoul, Korea, Korea, Republic of
Gangnam Severance Hospital 211
🇰🇷Seoul, Korea, Republic of
Bluegrass Allergy Research
🇺🇸Lexington, Kentucky, United States
University of Missouri Hospital
🇺🇸Columbia, Missouri, United States
Allergy and Asthma Consultants
🇺🇸Saint Louis, Missouri, United States
Asthma and Allergy Center
🇺🇸Bellevue, Nebraska, United States
Circuit Clinical/Mercer Allergy and Pulmonary Associates
🇺🇸Hamilton, New Jersey, United States
Circuit Clinical
🇺🇸Secaucus, New Jersey, United States
Dr. Patrick Perin
🇺🇸Teaneck, New Jersey, United States
Smith Allergy and Asthma
🇺🇸Horseheads, New York, United States
Allergy Partners
🇺🇸Asheville, North Carolina, United States
Bernstein Clinical Research Center, LLC
🇺🇸Cincinnati, Ohio, United States
Northwest Research Center
🇺🇸Portland, Oregon, United States
Allergy and Clinical Immunology Associates
🇺🇸Pittsburgh, Pennsylvania, United States
AARA Research Center
🇺🇸Dallas, Texas, United States
Kerrville Allergy and Asthma Associates
🇺🇸Kerrville, Texas, United States
UZ Gent
🇧🇪Gent, Oost-Vlaanderen, Belgium
Pneumocare
🇧🇪Erpent, Belgium
UZ Leuven, Pharmacy
🇧🇪Leuven, Belgium
Hôpital de la Citadelle
🇧🇪Liège, Belgium
Renmin Hospital of Wuhan University
🇨🇳Wu Han, Hubei, China
The Third Xiangya Hospital of Central South University
🇨🇳Changsha, Hunan, China
The First Affiliated Hospital of Nanchang University
🇨🇳Nanchang, Jiangxi, China
Internal Medicine Building
🇨🇳Beijing, China
Shengjing Hospital
🇨🇳Nanhu District, China
Tongji Hospital
🇨🇳Shanghai, China
Yangzhou University
🇨🇳Yangzhou City, China
Universitätsklinikum Carl Gustav Carus an der TU
🇩🇪Dresden, Germany
IKF Pneumologie
🇩🇪Frankfurt am Main, Germany
Siteworks - Zentrum für klinische Studien Heidelberg
🇩🇪Heidelberg, Germany
Zentrum für Rhinologie und Allergologie
🇩🇪Weisbaden, Germany
SMG-SNU Boramae Medical Center
🇰🇷Seoul, Korea, Republic of
Centrum Alergologii Teresa Hofman Sp z.o.o.
🇵🇱Pila, Poland
ClinMedica Research
🇵🇱Skierniewice, Poland
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
🇩🇪Marburg, Germany
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
B1F, Pharmacy department, Gachon University Gil Medical Center
🇰🇷Incheon, Korea, Republic of
ETG Warszawa
🇵🇱Warszawa, Mazowieckie, Poland
EMED Centrum Usług Medycznych
🇵🇱Rzeszow, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
🇵🇱Tarnow, Poland
ALL-MED - Specjalistyczna Opieka Medyczna
🇵🇱Wroclaw, Poland