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

Last updated: June 17, 2026
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

LY3650150

Standard therapy for INCS

Placebo

Clinical Study ID

NCT06339008
18789
J2T-MC-KGBT
2023-508817-18-00
  • Ages > 18
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed perennial allergic rhinitis (PAR).

  • Has a positive skin prick test (SPT) with indoor allergens and/or positive serumantigen-specific immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing avalidated assay (central laboratory).

  • The participant must have clinical symptoms at study entry associated with positiveperennial allergen as tested by the SPT or a positive serum antigen-specific IgEtest.

  • A participant who has a known history of dermatographism or identified during theSPT 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 toscreening using permitted regular asthma treatment.

Exclusion

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 yearsprior 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, includingJanus Kinase inhibitors (JAK) for inflammatory disease or autoimmune disease priorto the baseline visit:

  • Any current or prior use of biologics indicated for asthma or AD areprohibited.

  • 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 tobaseline.

  • Have a history of seasonal worsening of AR and if the seasonal worsening is expectedduring the 4-week run-in period, the first 16 weeks after randomization, or duringthe 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 pregnantor to breastfeed during the study.

Study Design

Total Participants: 450
Treatment Group(s): 4
Primary Treatment: LY3650150
Phase: 3
Study Start date:
April 26, 2024
Estimated Completion Date:
October 31, 2028

Connect with a study center

  • Hôpital Erasme, Service Pharmacie

    Brussels, 1070
    Belgium

    Site Not Available

  • Pneumocare

    Erpent, 5101
    Belgium

    Active - Recruiting

  • UZ Gent

    Ghent, 9000
    Belgium

    Active - Recruiting

  • UZ Leuven, Pharmacy

    Leuven, 3000
    Belgium

    Active - Recruiting

  • Hôpital de la Citadelle

    Liège, 4000
    Belgium

    Active - Recruiting

  • Department of Nasal Allergy

    Beijing, 100730
    China

    Active - Recruiting

  • Internal Medicine Building

    Beijing, 100032
    China

    Active - Recruiting

  • Department of Nasal Allergy

    Beijing 1816670, 100730
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha, 410013
    China

    Active - Recruiting

  • GCP Pharmacy

    Guangzhou, 510000
    China

    Active - Recruiting

  • GCP Pharmacy

    Guangzhou 1809858, 510000
    China

    Active - Recruiting

  • GCP Pharmacy

    Guangzhou City, 510000
    China

    Active - Recruiting

  • Zhejiang People's Hospital

    Hangzhou, 310014
    China

    Active - Recruiting

  • Jingzhou Central Hospital

    Jingzhou, 434020
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Active - Recruiting

  • The Second Affiliated Hospital of Nanchang University

    Nanchang, 330006
    China

    Active - Recruiting

  • The First Affiliated Hospital of Nanchang University

    Nanchang 1800163, 330006
    China

    Active - Recruiting

  • People's Hospital of Guangxi Zhuang Autonomous Region

    Nanning, 530021
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning, 530021
    China

    Site Not Available

  • The First Affiliated Hospital of Guangxi Medical University

    Nanning 1799869, 530021
    China

    Site Not Available

  • Tongji Hospital

    Shanghai, 200065
    China

    Active - Recruiting

  • Outpatient Department, Union Hospital

    Wuhan, 430022
    China

    Active - Recruiting

  • Outpatient building

    Wuhan, 430014
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan, 430060
    China

    Active - Recruiting

  • Outpatient building

    Wuhan 1791247, 430014
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan 1791247, 430060
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou, 225001
    China

    Active - Recruiting

  • Yangzhou University

    Yangzhou, 225012
    China

    Active - Recruiting

  • Northern Jiangsu People's Hospital

    Yangzhou 1787227, 225001
    China

    Active - Recruiting

  • Zhongshan City People's Hospital

    Zhongshan, 528403
    China

    Site Not Available

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie

    Berlin, 10117
    Germany

    Active - Recruiting

  • Praxis für HNO und Allergologie

    Dresden, 1139
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden, 1307
    Germany

    Site Not Available

  • Praxis für HNO und Allergologie

    Dresden 2935022, 1139
    Germany

    Active - Recruiting

  • IKF Pneumologie

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Siteworks - Zentrum für klinische Studien Heidelberg

    Heidelberg, 69115
    Germany

    Active - Recruiting

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

    Marburg, 35043
    Germany

    Active - Recruiting

  • Zentrum für Rhinologie und Allergologie

    Weisbaden, 65183
    Germany

    Active - Recruiting

  • Kyunghee University Hospital at Gangdong

    Seoul, Seoul, Korea 05278
    Korea, Republic of

    Site Not Available

  • Clinical trial Pharmacy

    Seoul, 8308
    Korea, Republic of

    Site Not Available

  • Gangnam Severance Hospital 211

    Seoul, 6273
    Korea, Republic of

    Site Not Available

  • SMG-SNU Boramae Medical Center

    Seoul, 7061
    Korea, Republic of

    Site Not Available

  • Polimedica PTG Kielce

    Kielce, 25-355
    Poland

    Active - Recruiting

  • Centrum Medyczne Promed ul. Olszańska 5G

    Krakow, 31-513
    Poland

    Active - Recruiting

  • Malopolskie Centrum Alergologii

    Krakow, 31-623
    Poland

    Active - Recruiting

  • Malopolskie Centrum Alergologii

    Krakow 3094802, 31-623
    Poland

    Active - Recruiting

  • gab. 114, ul. inż. pilota Wigury

    Lodz, 90-302
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin, 20-412
    Poland

    Active - Recruiting

  • Centrum Alergologii Teresa Hofman Sp z.o.o.

    Piła, 64-920
    Poland

    Active - Recruiting

  • EMED Centrum Usług Medycznych

    Rzeszów, 35-205
    Poland

    Active - Recruiting

  • ClinMedica Research

    Skierniewice, 96-100
    Poland

    Active - Recruiting

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

    Tarnow, 33-100
    Poland

    Active - Recruiting

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

    Tarnów, 33-100
    Poland

    Active - Recruiting

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

    Tarnów 757026, 33-100
    Poland

    Active - Recruiting

  • ETG Warszawa

    Warsaw, 02-793
    Poland

    Active - Recruiting

  • ALL-MED - Specjalistyczna Opieka Medyczna

    Wroclaw, 53-201
    Poland

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    South Korea

    Active - Recruiting

  • B1F, Pharmacy department, Gachon University Gil Medical Center

    Incheon, 21565
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si, 13620
    South Korea

    Active - Recruiting

  • Clinical trial Pharmacy

    Seoul, 8308
    South Korea

    Site Not Available

  • Gangnam Severance Hospital 211

    Seoul, 6273
    South Korea

    Active - Recruiting

  • Kyunghee University Hospital at Gangdong

    Seoul, 05278
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul, 7061
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    South Korea

    Site Not Available

  • Clinical trial Pharmacy

    Seoul 1835848, 8308
    South Korea

    Site Not Available

  • Kyunghee University Hospital at Gangdong

    Seoul 1835848, 05278
    South Korea

    Active - Recruiting

  • SMG-SNU Boramae Medical Center

    Seoul 1835848, 7061
    South Korea

    Site Not Available

  • Severance Hospital, Yonsei University Health System

    Seoul 1835848, 03722
    South Korea

    Site Not Available

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California 92648
    United States

    Active - Recruiting

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Active - Recruiting

  • Allergy & Asthma Associates of Southern California dba. Southern California Research

    Laguna Niguel, California 92677
    United States

    Active - Recruiting

  • Allergy and Asthma

    San Diego, California 92123
    United States

    Active - Recruiting

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado 80907-6231
    United States

    Active - Recruiting

  • Allergy and Asthma Diagnostic Center

    Tallahassee, Florida 32308
    United States

    Site Not Available

  • University of South Florida

    Tampa, Florida 33613
    United States

    Site Not Available

  • Asthma Allergy Center of Chicago

    Chicago, Illinois 60305
    United States

    Active - Recruiting

  • Northwestern University

    Chicago, Illinois 60611
    United States

    Site Not Available

  • Asthma Allergy Center of Chicago

    River Forest, Illinois 60305
    United States

    Active - Recruiting

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Active - Recruiting

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Active - Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Active - Recruiting

  • University of Missouri Hospital

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Allergy and Asthma Consultants

    St Louis, Missouri 63141
    United States

    Active - Recruiting

  • Asthma and Allergy Center

    Bellevue, Nebraska 68123
    United States

    Active - Recruiting

  • Circuit Clinical/Hudson-Essex Allergy

    Belleville, New Jersey 07109
    United States

    Active - Recruiting

  • Circuit Clinical/Mercer Allergy and Pulmonary Associates

    Hamilton, New Jersey 08619
    United States

    Active - Recruiting

  • Dr. Patrick Perin

    Teaneck, New Jersey 07666
    United States

    Active - Recruiting

  • Smith Allergy and Asthma

    Horseheads, New York 14845
    United States

    Active - Recruiting

  • Allergy Partners

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • Allergy Partners

    Asheville 4453066, North Carolina 4482348 28803
    United States

    Active - Recruiting

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Active - Recruiting

  • Northwest Research Center

    Portland, Oregon 97202
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Active - Recruiting

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Active - Recruiting

  • Kerrville Allergy and Asthma Associates

    Kerrville, Texas 78028
    United States

    Active - Recruiting

  • Allergy, Asthma & Sinus Center

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

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