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

Last updated: September 5, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Allergy

Common Cold

Nasal Obstruction

Treatment

Placebo

LY3650150

Standard therapy for INCS

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: Placebo
Phase: 3
Study Start date:
April 26, 2024
Estimated Completion Date:
February 28, 2027

Connect with a study center

  • UZ Gent

    Gent, Oost-Vlaanderen 9000
    Belgium

    Site Not Available

  • Hôpital Erasme, Service Pharmacie

    Brussels, 1070
    Belgium

    Site Not Available

  • Hôpital Erasme, Service Pharmacie

    Brussels 2800866, 1070
    Belgium

    Site Not Available

  • Pneumocare

    Erpent, 5101
    Belgium

    Site Not Available

  • Pneumocare

    Erpent 2798674, 5101
    Belgium

    Active - Recruiting

  • UZ Gent

    Ghent 2797656, 9000
    Belgium

    Site Not Available

  • UZ Leuven, Pharmacy

    Leuven, 3000
    Belgium

    Site Not Available

  • UZ Leuven, Pharmacy

    Leuven 2792482, 3000
    Belgium

    Active - Recruiting

  • Hôpital de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • Hôpital de la Citadelle

    Liège 2792413, 4000
    Belgium

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wu Han, Hubei 430060
    China

    Site Not Available

  • The Third Xiangya Hospital of Central South University

    Changsha, Hunan 410013
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou, Jiangsu 225001
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang, Jiangxi 330006
    China

    Site Not Available

  • Department of Nasal Allergy

    Beijing, 100730
    China

    Site Not Available

  • Internal Medicine Building

    Beijing, 100032
    China

    Active - Recruiting

  • Department of Nasal Allergy

    Beijing 1816670, 100730
    China

    Active - Recruiting

  • Internal Medicine Building

    Beijing 1816670, 100032
    China

    Active - Recruiting

  • The Third Xiangya Hospital of Central South University

    Changsha 1815577, 410013
    China

    Active - Recruiting

  • GCP Pharmacy

    Guangzhou 1809858, 510000
    China

    Active - Recruiting

  • GCP Pharmacy

    Guangzhou City, 510000
    China

    Site Not Available

  • Zhejiang People's Hospital

    Hangzhou 1808926, 310014
    China

    Active - Recruiting

  • Zhejiang People's Hospital

    Hangzhou City, 310014
    China

    Site Not Available

  • The First Affiliated Hospital of Nanchang University

    Nanchang 1800163, 330006
    China

    Site Not Available

  • Shengjing Hospital

    Nanhu District, 110055
    China

    Site Not Available

  • Tongji Hospital

    Shanghai, 200065
    China

    Site Not Available

  • Tongji Hospital

    Shanghai 1796236, 200065
    China

    Active - Recruiting

  • Outpatient Department, Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • Outpatient Department, Union Hospital

    Wuhan 1791247, 430022
    China

    Active - Recruiting

  • Outpatient building

    Wuhan 1791247, 430014
    China

    Active - Recruiting

  • Renmin Hospital of Wuhan University

    Wuhan 1791247, 430060
    China

    Active - Recruiting

  • Outpatient building

    Wuhan City, 430014
    China

    Site Not Available

  • Northern Jiangsu People's Hospital

    Yangzhou 1787227, 225001
    China

    Active - Recruiting

  • Yangzhou University

    Yangzhou 1787227, 225012
    China

    Active - Recruiting

  • Yangzhou University

    Yangzhou City, 225012
    China

    Site Not Available

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie

    Berlin, 10117
    Germany

    Site Not Available

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie

    Berlin 2950159, 10117
    Germany

    Active - Recruiting

  • Praxis für HNO und Allergologie

    Dresden, 1139
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden, 1307
    Germany

    Site Not Available

  • Praxis für HNO und Allergologie

    Dresden 2935022, 1139
    Germany

    Active - Recruiting

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden 2935022, 1307
    Germany

    Site Not Available

  • IKF Pneumologie

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • IKF Pneumologie

    Frankfurt am Main 2925533, 60596
    Germany

    Site Not Available

  • Siteworks - Zentrum für klinische Studien Heidelberg

    Heidelberg, 69115
    Germany

    Site Not Available

  • Siteworks - Zentrum für klinische Studien Heidelberg

    Heidelberg 2907911, 69115
    Germany

    Active - Recruiting

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

    Marburg, 35043
    Germany

    Site Not Available

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

    Marburg 2873759, 35043
    Germany

    Active - Recruiting

  • Zentrum für Rhinologie und Allergologie

    Weisbaden, 65183
    Germany

    Active - Recruiting

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do 13620
    Korea, Republic of

    Site Not Available

  • Kyunghee University Hospital at Gangdong

    Seoul, Seoul, Korea 05278
    Korea, Republic of

    Site Not Available

  • Inje University Haeundae Paik Hospital

    Busan, 48108
    Korea, Republic of

    Site Not Available

  • B1F, Pharmacy department, Gachon University Gil Medical Center

    Incheon, 21565
    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

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722
    Korea, Republic of

    Site Not Available

  • ETG Warszawa

    Warszawa, Mazowieckie 02-793
    Poland

    Site Not Available

  • Polimedica PTG Kielce

    Kielce, 25-355
    Poland

    Site Not Available

  • Polimedica PTG Kielce

    Kielce 769250, 25-355
    Poland

    Active - Recruiting

  • Centrum Medyczne Promed ul. Olszańska 5G

    Krakow, 31-513
    Poland

    Active - Recruiting

  • Malopolskie Centrum Alergologii

    Krakow, 31-623
    Poland

    Site Not Available

  • Centrum Medyczne Promed ul. Olszańska 5G

    Krakow 3094802, 31-513
    Poland

    Active - Recruiting

  • Malopolskie Centrum Alergologii

    Krakow 3094802, 31-623
    Poland

    Active - Recruiting

  • gab. 114, ul. inż. pilota Wigury

    Lodz, 90-302
    Poland

    Site Not Available

  • gab. 114, ul. inż. pilota Wigury

    Lodz 3093133, 90-302
    Poland

    Active - Recruiting

  • ETG Lublin

    Lublin, 20-412
    Poland

    Site Not Available

  • ETG Lublin

    Lublin 765876, 20-412
    Poland

    Active - Recruiting

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

    Pila, 64-920
    Poland

    Site Not Available

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

    Piła 3089033, 64-920
    Poland

    Active - Recruiting

  • EMED Centrum Usług Medycznych

    Rzeszow, 35-205
    Poland

    Site Not Available

  • EMED Centrum Usług Medycznych

    Rzeszów 759734, 35-205
    Poland

    Active - Recruiting

  • ClinMedica Research

    Skierniewice, 96-100
    Poland

    Site Not Available

  • ClinMedica Research

    Skierniewice 759123, 96-100
    Poland

    Active - Recruiting

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

    Tarnow, 33-100
    Poland

    Site Not Available

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

    Tarnów 757026, 33-100
    Poland

    Active - Recruiting

  • ETG Warszawa

    Warsaw 756135, 02-793
    Poland

    Active - Recruiting

  • ALL-MED - Specjalistyczna Opieka Medyczna

    Wroclaw, 53-201
    Poland

    Site Not Available

  • ALL-MED - Specjalistyczna Opieka Medyczna

    Wroclaw 3081368, 53-201
    Poland

    Active - Recruiting

  • Inje University Haeundae Paik Hospital

    Busan 1838524, 48108
    South Korea

    Site Not Available

  • B1F, Pharmacy department, Gachon University Gil Medical Center

    Incheon 1843564, 21565
    South Korea

    Site Not Available

  • Seoul National University Bundang Hospital

    Seongnam-si 1897000, 13620
    South Korea

    Active - Recruiting

  • Clinical trial Pharmacy

    Seoul 1835848, 8308
    South Korea

    Site Not Available

  • Gangnam Severance Hospital 211

    Seoul 1835848, 6273
    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

  • Southern California Research

    California City, California 92691
    United States

    Site Not Available

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach, California 92648
    United States

    Site Not Available

  • 310 Clinical Research

    Inglewood, California 90301
    United States

    Site Not Available

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

    Laguna Niguel, California 92677
    United States

    Site Not Available

  • Allergy and Asthma

    San Diego, California 92123
    United States

    Site Not Available

  • Allergy and Asthma Specialists Medical Group

    Huntington Beach 5358705, California 5332921 92648
    United States

    Active - Recruiting

  • 310 Clinical Research

    Inglewood 5359488, California 5332921 90301
    United States

    Active - Recruiting

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

    Laguna Niguel 5364329, California 5332921 92677
    United States

    Active - Recruiting

  • Allergy and Asthma

    San Diego 5391811, California 5332921 92123
    United States

    Active - Recruiting

  • Asthma and Allergy Associates, PC

    Colorado Springs, Colorado 80907-6231
    United States

    Site Not Available

  • Asthma and Allergy Associates, PC

    Colorado Springs 5417598, Colorado 5417618 80907-6231
    United States

    Active - Recruiting

  • Florida Center For Allergy & Asthma Care Aventura

    Aventura, Florida 33180
    United States

    Site Not Available

  • 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

  • Allergy and Asthma Diagnostic Center

    Tallahassee 4174715, Florida 4155751 32308
    United States

    Site Not Available

  • University of South Florida

    Tampa 4174757, Florida 4155751 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

    Site Not Available

  • Northwestern University

    Chicago 4887398, Illinois 4896861 60611
    United States

    Site Not Available

  • Asthma Allergy Center of Chicago

    River Forest 4907637, Illinois 4896861 60305
    United States

    Active - Recruiting

  • Bluegrass Allergy Research

    Lexington, Kentucky 40509
    United States

    Site Not Available

  • Bluegrass Allergy Research

    Lexington 4297983, Kentucky 6254925 40509
    United States

    Active - Recruiting

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti, Michigan 48197
    United States

    Site Not Available

  • Respiratory Medicine Research Institute of Michigan, PLC

    Ypsilanti 5015688, Michigan 5001836 48197
    United States

    Active - Recruiting

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Clinical Research Institute

    Minneapolis 5037649, Minnesota 5037779 55402
    United States

    Active - Recruiting

  • University of Missouri Hospital

    Columbia, Missouri 65212
    United States

    Site Not Available

  • Allergy and Asthma Consultants

    Saint Louis, Missouri 63141
    United States

    Site Not Available

  • University of Missouri Hospital

    Columbia 4381982, Missouri 4398678 65212
    United States

    Site Not Available

  • Allergy and Asthma Consultants

    St Louis 4407066, Missouri 4398678 63141
    United States

    Active - Recruiting

  • Asthma and Allergy Center

    Bellevue, Nebraska 68123
    United States

    Site Not Available

  • Asthma and Allergy Center

    Bellevue 5063805, Nebraska 5073708 68123
    United States

    Active - Recruiting

  • Circuit Clinical/Hudson-Essex Allergy

    Belleville, New Jersey 07109
    United States

    Site Not Available

  • Circuit Clinical/Mercer Allergy and Pulmonary Associates

    Hamilton, New Jersey 08619
    United States

    Site Not Available

  • Circuit Clinical

    Secaucus, New Jersey 07094
    United States

    Site Not Available

  • Dr. Patrick Perin

    Teaneck, New Jersey 07666
    United States

    Site Not Available

  • Circuit Clinical/Hudson-Essex Allergy

    Belleville 5095549, New Jersey 5101760 07109
    United States

    Active - Recruiting

  • Circuit Clinical/Mercer Allergy and Pulmonary Associates

    Hamilton 5098765, New Jersey 5101760 08619
    United States

    Active - Recruiting

  • Dr. Patrick Perin

    Teaneck 5105262, New Jersey 5101760 07666
    United States

    Active - Recruiting

  • Smith Allergy and Asthma

    Horseheads, New York 14845
    United States

    Site Not Available

  • Smith Allergy and Asthma

    Ithaca, New York 14845
    United States

    Site Not Available

  • Smith Allergy and Asthma

    Horseheads 5121309, New York 5128638 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

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati, Ohio 45236
    United States

    Site Not Available

  • Bernstein Clinical Research Center, LLC

    Cincinnati 4508722, Ohio 5165418 45236
    United States

    Active - Recruiting

  • Northwest Research Center

    Portland, Oregon 97202
    United States

    Site Not Available

  • Northwest Research Center

    Portland 5746545, Oregon 5744337 97202
    United States

    Active - Recruiting

  • Allergy and Clinical Immunology Associates

    Pittsburgh, Pennsylvania 15241
    United States

    Site Not Available

  • Allergy and Clinical Immunology Associates

    Pittsburgh 5206379, Pennsylvania 6254927 15241
    United States

    Active - Recruiting

  • AARA Research Center

    Dallas, Texas 75231
    United States

    Site Not Available

  • Kerrville Allergy and Asthma Associates

    Kerrville, Texas 78028
    United States

    Site Not Available

  • Allergy Asthma Research Institute

    Waco, Texas 76712
    United States

    Site Not Available

  • AARA Research Center

    Dallas 4684888, Texas 4736286 75231
    United States

    Active - Recruiting

  • Kerrville Allergy and Asthma Associates

    Kerrville 4703078, Texas 4736286 78028
    United States

    Active - Recruiting

  • Allergy, Asthma & Sinus Center

    Greenfield, Wisconsin 53228
    United States

    Site Not Available

  • Allergy, Asthma & Sinus Center

    Greenfield 5255068, Wisconsin 5279468 53228
    United States

    Active - Recruiting

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