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

Status: Recruiting
Location: See all (72) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Allergy and Asthma Specialists Medical Group
RECRUITING
Huntington Beach
310 Clinical Research
RECRUITING
Inglewood
Allergy & Asthma Associates of Southern California dba. Southern California Research
RECRUITING
Laguna Niguel
Allergy and Asthma
RECRUITING
San Diego
Colorado
Asthma and Allergy Associates, PC
RECRUITING
Colorado Springs
Florida
Allergy and Asthma Diagnostic Center
NOT_YET_RECRUITING
Tallahassee
University of South Florida
NOT_YET_RECRUITING
Tampa
Illinois
Northwestern University
NOT_YET_RECRUITING
Chicago
Asthma Allergy Center of Chicago
RECRUITING
River Forest
Kentucky
Bluegrass Allergy Research
RECRUITING
Lexington
Michigan
Respiratory Medicine Research Institute of Michigan, PLC
RECRUITING
Ypsilanti
Minnesota
Clinical Research Institute
RECRUITING
Minneapolis
Missouri
University of Missouri Hospital
NOT_YET_RECRUITING
Columbia
Allergy and Asthma Consultants
RECRUITING
St Louis
North Carolina
Allergy Partners
NOT_YET_RECRUITING
Asheville
Allergy Partners
RECRUITING
Asheville
Nebraska
Asthma and Allergy Center
RECRUITING
Bellevue
New Jersey
Circuit Clinical/Hudson-Essex Allergy
RECRUITING
Belleville
Circuit Clinical/Mercer Allergy and Pulmonary Associates
RECRUITING
Hamilton
Dr. Patrick Perin
RECRUITING
Teaneck
New York
Smith Allergy and Asthma
RECRUITING
Horseheads
Ohio
Bernstein Clinical Research Center, LLC
RECRUITING
Cincinnati
Oregon
Northwest Research Center
RECRUITING
Portland
Pennsylvania
Allergy and Clinical Immunology Associates
RECRUITING
Pittsburgh
Texas
AARA Research Center
RECRUITING
Dallas
Kerrville Allergy and Asthma Associates
RECRUITING
Kerrville
Wisconsin
Allergy, Asthma & Sinus Center
RECRUITING
Greenfield
Other Locations
Belgium
Hôpital Erasme, Service Pharmacie
NOT_YET_RECRUITING
Brussels
Pneumocare
RECRUITING
Erpent
UZ Gent
NOT_YET_RECRUITING
Ghent
UZ Leuven, Pharmacy
RECRUITING
Leuven
Hôpital de la Citadelle
RECRUITING
Liège
China
Department of Nasal Allergy
RECRUITING
Beijing
Internal Medicine Building
RECRUITING
Beijing
The Third Xiangya Hospital of Central South University
RECRUITING
Changsha
GCP Pharmacy
RECRUITING
Guangzhou
GCP Pharmacy
RECRUITING
Guangzhou
Zhejiang People's Hospital
RECRUITING
Hangzhou
The First Affiliated Hospital of Nanchang University
RECRUITING
Nanchang
Tongji Hospital
RECRUITING
Shanghai
Outpatient building
RECRUITING
Wuhan
Outpatient Department, Union Hospital
RECRUITING
Wuhan
Renmin Hospital of Wuhan University
RECRUITING
Wuhan
Northern Jiangsu People's Hospital
RECRUITING
Yangzhou
Yangzhou University
RECRUITING
Yangzhou
Germany
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
RECRUITING
Berlin
Praxis für HNO und Allergologie
RECRUITING
Dresden
Universitätsklinikum Carl Gustav Carus an der TU
NOT_YET_RECRUITING
Dresden
IKF Pneumologie
NOT_YET_RECRUITING
Frankfurt Am Main
Siteworks - Zentrum für klinische Studien Heidelberg
RECRUITING
Heidelberg
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
RECRUITING
Marburg
Zentrum für Rhinologie und Allergologie
RECRUITING
Weisbaden
Poland
Polimedica PTG Kielce
RECRUITING
Kielce
Centrum Medyczne Promed ul. Olszańska 5G
RECRUITING
Krakow
Malopolskie Centrum Alergologii
RECRUITING
Krakow
gab. 114, ul. inż. pilota Wigury
RECRUITING
Lodz
ETG Lublin
RECRUITING
Lublin
Centrum Alergologii Teresa Hofman Sp z.o.o.
RECRUITING
Piła
EMED Centrum Usług Medycznych
RECRUITING
Rzeszów
ClinMedica Research
RECRUITING
Skierniewice
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
RECRUITING
Tarnów
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
RECRUITING
Tarnów
ETG Warszawa
RECRUITING
Warsaw
ALL-MED - Specjalistyczna Opieka Medyczna
RECRUITING
Wroclaw
Republic of Korea
Inje University Haeundae Paik Hospital
RECRUITING
Busan
B1F, Pharmacy department, Gachon University Gil Medical Center
NOT_YET_RECRUITING
Incheon
Seoul National University Bundang Hospital
RECRUITING
Seongnam-si
Clinical trial Pharmacy
NOT_YET_RECRUITING
Seoul
Gangnam Severance Hospital 211
RECRUITING
Seoul
Kyunghee University Hospital at Gangdong
RECRUITING
Seoul
Severance Hospital, Yonsei University Health System
NOT_YET_RECRUITING
Seoul
SMG-SNU Boramae Medical Center
NOT_YET_RECRUITING
Seoul
Contact Information
Primary
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
LillyTrials@Lilly.com
1-317-615-4559
Backup
Physicians interested in becoming principal investigators please contact
clinical_inquiry_hub@lilly.com
Time Frame
Start Date: 2024-04-26
Estimated Completion Date: 2028-10
Participants
Target number of participants: 450
Treatments
Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W)
Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Placebo_comparator: Placebo Q2W/Q4W
Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Related Therapeutic Areas
Sponsors
Leads: Eli Lilly and Company

This content was sourced from clinicaltrials.gov