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RECRUITING

NCT06339008

PHASE3

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

Sponsor: Eli Lilly and Company

View on ClinicalTrials.gov

Summary

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.

Official title: A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled, Parallel Group Study to Evaluate the Efficacy and Safety of Lebrikizumab/ LY3650150 in Adult Participants With Perennial Allergic Rhinitis

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

450

Start Date

2024-04-26

Completion Date

2028-10

Last Updated

2026-03-24

Healthy Volunteers

Conditions

Perennial Allergic Rhinitis (PAR)

Interventions

DRUG

LY3650150

Administered SC

DRUG

Placebo

Administered SC

DRUG

Standard therapy for INCS

Administered as intranasal spray

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.

Locations (70)

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

Allergy and Asthma Diagnostic Center

Tallahassee, Florida, United States

University of South Florida

Tampa, Florida, United States

Northwestern University

Chicago, Illinois, United States

Asthma Allergy Center of Chicago

River Forest, Illinois, United States

Bluegrass Allergy Research

Lexington, Kentucky, United States

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, United States

Clinical Research Institute

Minneapolis, Minnesota, United States

University of Missouri Hospital

Columbia, Missouri, United States

Asthma and Allergy Center

Bellevue, Nebraska, United States

Circuit Clinical/Hudson-Essex Allergy

Belleville, New Jersey, United States

Circuit Clinical/Mercer Allergy and Pulmonary Associates

Hamilton, New Jersey, United States

Dr. Patrick Perin

Teaneck, New Jersey, United States

Allergy Partners

Asheville, North Carolina, United States

Northwest Research Center

Portland, Oregon, United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, United States

Kerrville Allergy and Asthma Associates

Kerrville, Texas, United States

Allergy, Asthma & Sinus Center

Greenfield, Wisconsin, United States

Hôpital Erasme, Service Pharmacie

Brussels, Belgium

Pneumocare

Erpent, Belgium

UZ Gent

Ghent, Belgium

UZ Leuven, Pharmacy

Leuven, Belgium

Hôpital de la Citadelle

Liège, Belgium

Internal Medicine Building

Beijing, China

Department of Nasal Allergy

Beijing, China

The Third Xiangya Hospital of Central South University

Changsha, China

GCP Pharmacy

Guangzhou, China

GCP Pharmacy

Guangzhou, China

Zhejiang People's Hospital

Hangzhou, China

Jingzhou Central Hospital

Jingzhou, China

The First Affiliated Hospital of Nanchang University

Nanchang, China

The Second Affiliated Hospital of Nanchang University

Nanchang, China

People's Hospital of Guangxi Zhuang Autonomous Region

Nanning, China

The First Affiliated Hospital of Guangxi Medical University

Nanning, China

Tongji Hospital

Shanghai, China

Outpatient building

Wuhan, China

Outpatient Department, Union Hospital

Wuhan, China

Renmin Hospital of Wuhan University

Wuhan, China

Northern Jiangsu People's Hospital

Yangzhou, China

Yangzhou University

Yangzhou, China

Zhongshan City People's Hospital

Zhongshan, China

Charité - Universitätsmedizin Berlin Klinik für Dermatologie

Berlin, Germany

Praxis für HNO und Allergologie

Dresden, Germany

Universitätsklinikum Carl Gustav Carus an der TU

Dresden, Germany

IKF Pneumologie

Frankfurt am Main, Germany

Siteworks - Zentrum für klinische Studien Heidelberg

Heidelberg, Germany

Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie

Marburg, Germany

Zentrum für Rhinologie und Allergologie

Weisbaden, Germany

Polimedica PTG Kielce

Kielce, Poland

Centrum Medyczne Promed ul. Olszańska 5G

Krakow, Poland

Malopolskie Centrum Alergologii

Krakow, Poland

gab. 114, ul. inż. pilota Wigury

Lodz, Poland

ETG Lublin

Lublin, Poland

Centrum Alergologii Teresa Hofman Sp z.o.o.

Piła, Poland

EMED Centrum Usług Medycznych

Rzeszów, Poland

ClinMedica Research

Skierniewice, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

Tarnów, Poland

Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.

Tarnów, Poland

ETG Warszawa

Warsaw, Poland

Inje University Haeundae Paik Hospital

Busan, South Korea

B1F, Pharmacy department, Gachon University Gil Medical Center

Incheon, South Korea

Seoul National University Bundang Hospital

Seongnam-si, South Korea

Severance Hospital, Yonsei University Health System

Seoul, South Korea

Kyunghee University Hospital at Gangdong

Seoul, South Korea

Gangnam Severance Hospital 211

Seoul, South Korea

SMG-SNU Boramae Medical Center

Seoul, South Korea

Clinical trial Pharmacy

Seoul, South Korea

Clinical Research Directory

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

Summary

Key Details

Conditions

Interventions

Eligibility Criteria

Locations (70)