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

Last updated: February 27, 2025
Sponsor: Eli Lilly and Company
Overall Status: Active - Recruiting

Phase

3

Condition

Rhinitis, Allergic, Perennial

Allergy

Common Cold

Treatment

Standard therapy for INCS

Placebo

LY3650150

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. The study will last about 18 months

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Physician-diagnosed PAR.

  • Has a positive skin prick test (SPT) with indoor allergens and/or positiveantigen-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 oridentified during the SPT may participate in this study with a positive serum IgEtest.

  • 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 allergen immunotherapy. However, individuals who discontinuedsubcutaneous or sublingual immunotherapy (SCIT/SLIT) for ≥3 years prior torandomization are eligible, if they were not on a maintenance allergen immunotherapy (AIT) regimen.

  • Have received treatment with any rescue medication during the screening and/orrun-in period.

  • Have received treatment with any biologic or systemic immunosuppressants forinflammatory disease or autoimmune disease prior to the baseline visit:

  1. B cell-depleting biologics, including rituximab, within 6 months.

  2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.

  3. Systemic immunosuppressants within 4 weeks prior to baseline.

  • 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 4 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: Standard therapy for INCS
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

  • Pneumocare

    Erpent, 5101
    Belgium

    Site Not Available

  • UZ Leuven, Pharmacy

    Leuven, 3000
    Belgium

    Site Not Available

  • Hôpital de la Citadelle

    Liège, 4000
    Belgium

    Site Not Available

  • 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

  • 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

    Site Not Available

  • GCP Pharmacy

    Guangzhou City, 510000
    China

    Site Not Available

  • Zhejiang People's Hospital

    Hangzhou City, 310014
    China

    Active - Recruiting

  • Shengjing Hospital

    Nanhu District, 110055
    China

    Site Not Available

  • Tongji Hospital

    Shanghai, 200065
    China

    Site Not Available

  • Outpatient Department, Union Hospital

    Wuhan, 430022
    China

    Site Not Available

  • Outpatient building

    Wuhan City, 430014
    China

    Active - Recruiting

  • Yangzhou University

    Yangzhou City, 225012
    China

    Site Not Available

  • Charité - Universitätsmedizin Berlin Klinik für Dermatologie

    Berlin, 10117
    Germany

    Site Not Available

  • Praxis für HNO und Allergologie

    Dresden, 1139
    Germany

    Site Not Available

  • Universitätsklinikum Carl Gustav Carus an der TU

    Dresden, 1307
    Germany

    Site Not Available

  • IKF Pneumologie

    Frankfurt am Main, 60596
    Germany

    Site Not Available

  • Siteworks - Zentrum für klinische Studien Heidelberg

    Heidelberg, 69115
    Germany

    Site Not Available

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

    Marburg, 35043
    Germany

    Site Not Available

  • Zentrum für Rhinologie und Allergologie

    Weisbaden, 65183
    Germany

    Site Not Available

  • 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

  • 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

  • ETG Warszawa

    Warszawa, Mazowieckie 02-793
    Poland

    Site Not Available

  • Polimedica PTG Kielce

    Kielce, 25-355
    Poland

    Site Not Available

  • Centrum Medyczne Promed ul. Olszańska 5G

    Krakow, 31-513
    Poland

    Site Not Available

  • gab. 114, ul. inż. pilota Wigury

    Lodz, 90-302
    Poland

    Site Not Available

  • ETG Lublin

    Lublin, 20-412
    Poland

    Site Not Available

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

    Pila, 64-920
    Poland

    Site Not Available

  • EMED Centrum Usług Medycznych

    Rzeszow, 35-205
    Poland

    Site Not Available

  • ClinMedica Research

    Skierniewice, 96-100
    Poland

    Site Not Available

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

    Tarnow, 33-100
    Poland

    Site Not Available

  • ALL-MED - Specjalistyczna Opieka Medyczna

    Wroclaw, 53-201
    Poland

    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

    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

  • Florida Center For Allergy & Asthma Care Aventura

    Aventura, Florida 33180
    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

  • 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

    Saint Louis, Missouri 63141
    United States

    Active - Recruiting

  • Asthma and Allergy Center

    Bellevue, Nebraska 68123
    United States

    Active - Recruiting

  • 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

    Active - Recruiting

  • Smith Allergy and Asthma

    Horseheads, New York 14845
    United States

    Active - Recruiting

  • Smith Allergy and Asthma

    Ithaca, New York 14845
    United States

    Site Not Available

  • Allergy Partners

    Asheville, North Carolina 28803
    United States

    Site Not Available

  • 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

    Site Not Available

  • Kerrville Allergy and Asthma Associates

    Kerrville, Texas 78028
    United States

    Active - Recruiting

  • Allergy Asthma Research Institute

    Waco, Texas 76712
    United States

    Site Not Available

  • Allergy, Asthma & Sinus Center

    Greenfield, Wisconsin 53228
    United States

    Active - Recruiting

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