Language: BG BG
← Back to results
Recruiting Phase 3 NCT06339008

A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)

Phase 3 – large-scale trial before approval
Conditions: Perennial Allergic Rhinitis (PAR)

Sponsor: Eli Lilly and Company

trial.available_in: БГ
Overview
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.
Who can participate
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: * Have received a dose of lebrikizumab. * 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. * Have received treatment with any rescue medication during the run-in period. * 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. * 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. * Anticipates significant changes in their daily environmental exposure. * Has a known history of recurrent acute or chronic sinusitis. * Female participant who is pregnant, breastfeeding or is planning to become pregnant or to breastfeed during the study.
Interventions
LY3650150
DRUG
Placebo
DRUG
Standard therapy for INCS
DRUG
Locations 77
Belgium (5)
Hôpital Erasme, Service Pharmacie
Brussels
NOT_YET_RECRUITING
Pneumocare
Erpent
UZ Gent
Ghent
NOT_YET_RECRUITING
UZ Leuven, Pharmacy
Leuven
Hôpital de la Citadelle
Liège
China (18)
Internal Medicine Building
Beijing
Department of Nasal Allergy
Beijing
The Third Xiangya Hospital of Central South University
Changsha
GCP Pharmacy
Guangzhou
GCP Pharmacy
Guangzhou
Zhejiang People's Hospital
Hangzhou
Jingzhou Central Hospital
Jingzhou
The First Affiliated Hospital of Nanchang University
Nanchang
The Second Affiliated Hospital of Nanchang University
Nanchang
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning
NOT_YET_RECRUITING
The First Affiliated Hospital of Guangxi Medical University
Nanning
NOT_YET_RECRUITING
Tongji Hospital
Shanghai
Outpatient building
Wuhan
Outpatient Department, Union Hospital
Wuhan
Renmin Hospital of Wuhan University
Wuhan
Northern Jiangsu People's Hospital
Yangzhou
Yangzhou University
Yangzhou
Zhongshan City People's Hospital
Zhongshan
NOT_YET_RECRUITING
Germany (7)
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
Berlin
Praxis für HNO und Allergologie
Dresden
Universitätsklinikum Carl Gustav Carus an der TU
Dresden
NOT_YET_RECRUITING
IKF Pneumologie
Frankfurt am Main
NOT_YET_RECRUITING
Siteworks - Zentrum für klinische Studien Heidelberg
Heidelberg
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
Marburg
Zentrum für Rhinologie und Allergologie
Weisbaden
Poland (12)
Polimedica PTG Kielce
Kielce
Centrum Medyczne Promed ul. Olszańska 5G
Krakow
Malopolskie Centrum Alergologii
Krakow
gab. 114, ul. inż. pilota Wigury
Lodz
ETG Lublin
Lublin
Centrum Alergologii Teresa Hofman Sp z.o.o.
Piła
EMED Centrum Usług Medycznych
Rzeszów
ClinMedica Research
Skierniewice
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów
ETG Warszawa
Warsaw
ALL-MED - Specjalistyczna Opieka Medyczna
Wroclaw
South Korea (8)
Inje University Haeundae Paik Hospital
Busan
B1F, Pharmacy department, Gachon University Gil Medical Center
Incheon
NOT_YET_RECRUITING
Seoul National University Bundang Hospital
Seongnam-si
Severance Hospital, Yonsei University Health System
Seoul
NOT_YET_RECRUITING
Kyunghee University Hospital at Gangdong
Seoul
Gangnam Severance Hospital 211
Seoul
SMG-SNU Boramae Medical Center
Seoul
NOT_YET_RECRUITING
Clinical trial Pharmacy
Seoul
NOT_YET_RECRUITING
United States (27)
Allergy Partners
Asheville , North Carolina
Allergy Partners
Asheville , North Carolina
NOT_YET_RECRUITING
Circuit Clinical/Hudson-Essex Allergy
Belleville , New Jersey
Asthma and Allergy Center
Bellevue , Nebraska
Northwestern University
Chicago , Illinois
NOT_YET_RECRUITING
Bernstein Clinical Research Center, LLC
Cincinnati , Ohio
Asthma and Allergy Associates, PC
Colorado Springs , Colorado
University of Missouri Hospital
Columbia , Missouri
NOT_YET_RECRUITING
AARA Research Center
Dallas , Texas
Allergy, Asthma & Sinus Center
Greenfield , Wisconsin
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton , New Jersey
Smith Allergy and Asthma
Horseheads , New York
Allergy and Asthma Specialists Medical Group
Huntington Beach , California
310 Clinical Research
Inglewood , California
Kerrville Allergy and Asthma Associates
Kerrville , Texas
Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel , California
Bluegrass Allergy Research
Lexington , Kentucky
Clinical Research Institute
Minneapolis , Minnesota
Allergy and Clinical Immunology Associates
Pittsburgh , Pennsylvania
Northwest Research Center
Portland , Oregon
Asthma Allergy Center of Chicago
River Forest , Illinois
Allergy and Asthma
San Diego , California
Allergy and Asthma Consultants
St Louis , Missouri
Allergy and Asthma Diagnostic Center
Tallahassee , Florida
NOT_YET_RECRUITING
University of South Florida
Tampa , Florida
NOT_YET_RECRUITING
Dr. Patrick Perin
Teaneck , New Jersey
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti , Michigan
Technical details
Status
Recruiting
Phase
Phase 3
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Healthy volunteers
No
Start date
26.04.2024
Completion date
01.10.2028
Registry ID
NCT06339008
Source
clinicaltrials.gov
trial.inquiry_btn

Information is automatically extracted from ClinicalTrials.gov. Consult your doctor before taking action.