A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
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
3 other identifiers
interventional
450
6 countries
74
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_3
Started Apr 2024
Typical duration for phase_3
74 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 25, 2024
CompletedFirst Posted
Study publicly available on registry
April 1, 2024
CompletedStudy Start
First participant enrolled
April 26, 2024
CompletedPrimary Completion
Last participant's last visit for primary outcome
September 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
October 1, 2028
July 22, 2026
July 1, 2026
2.4 years
March 25, 2024
July 21, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16
Total nasal symptom score was a composite of 4 symptoms (rhinorrhea, nasal congestion, nasal itching and sneezing), each symptom was scored on a scale of 0 = none, 1 = mild, 2 = moderate, 3 = severe. The total score ranged from 0 to 12. The higher the score was, the more severe the symptoms were.
Baseline, Week 16
Secondary Outcomes (7)
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16
Baseline, Week 16
Mean CFBL in RQLQ(S) Activities Domain at Week 56
Baseline, Week 56
Mean CFBL in RQLQ(S) Total Score at Week 16
Baseline, Week 16
Mean CFBL in RQLQ(S) Total Score at Week 56
Baseline, Week 56
Mean CFBL in TNSS at Week 4
Baseline, Week 4
- +2 more secondary outcomes
Study Arms (3)
Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)
EXPERIMENTALLebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Lebrikizumab Q2W/every 8 weeks (Q8W)
EXPERIMENTALLebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Placebo Q2W/Q4W
PLACEBO COMPARATORPlacebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.
Interventions
Administered SC
Administered as intranasal spray
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (74)
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, 92648, United States
310 Clinical Research
Inglewood, California, 90301, United States
Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California, 92677, United States
Allergy and Asthma
San Diego, California, 92123, United States
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907-6231, United States
Allergy and Asthma Diagnostic Center
Tallahassee, Florida, 32308, United States
University of South Florida
Tampa, Florida, 33613, United States
Northwestern University
Chicago, Illinois, 60611, United States
Asthma Allergy Center of Chicago
River Forest, Illinois, 60305, United States
Bluegrass Allergy Research
Lexington, Kentucky, 40509, United States
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197, United States
Clinical Research Institute
Minneapolis, Minnesota, 55402, United States
University of Missouri Hospital
Columbia, Missouri, 65212, United States
Allergy and Asthma Consultants
St Louis, Missouri, 63141, United States
Asthma and Allergy Center
Bellevue, Nebraska, 68123, United States
Circuit Clinical/Hudson-Essex Allergy
Belleville, New Jersey, 07109, United States
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, 08619, United States
Dr. Patrick Perin
Teaneck, New Jersey, 07666, United States
Smith Allergy and Asthma
Horseheads, New York, 14845, United States
Allergy Partners
Asheville, North Carolina, 28803, United States
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236, United States
Northwest Research Center
Portland, Oregon, 97202, United States
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241, United States
AARA Research Center
Dallas, Texas, 75231, United States
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028, United States
Allergy, Asthma & Sinus Center
Greenfield, Wisconsin, 53228, United States
Hôpital Erasme, Service Pharmacie
Brussels, 1070, Belgium
Pneumocare
Erpent, 5101, Belgium
UZ Gent
Ghent, 9000, Belgium
UZ Leuven, Pharmacy
Leuven, 3000, Belgium
Hôpital de la Citadelle
Liège, 4000, Belgium
Internal Medicine Building
Beijing, 100032, China
Department of Nasal Allergy
Beijing, 100730, China
The Third Xiangya Hospital of Central South University
Changsha, 410013, China
GCP Pharmacy
Guangzhou, 510000, China
Zhejiang People's Hospital
Hangzhou, 310014, China
Jingzhou Central Hospital
Jingzhou, 434020, China
The First Affiliated Hospital of Nanchang University
Nanchang, 330006, China
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006, China
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021, China
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021, China
Tongji Hospital
Shanghai, 200065, China
Outpatient building
Wuhan, 430014, China
Outpatient Department, Union Hospital
Wuhan, 430022, China
Renmin Hospital of Wuhan University
Wuhan, 430060, China
Northern Jiangsu People's Hospital
Yangzhou, 225001, China
Yangzhou University
Yangzhou, 225012, China
Zhongshan City People's Hospital
Zhongshan, 528403, China
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
Berlin, 10117, Germany
Praxis für HNO und Allergologie
Dresden, 1139, Germany
Universitätsklinikum Carl Gustav Carus an der TU
Dresden, 1307, Germany
IKF Pneumologie
Frankfurt am Main, 60596, Germany
Siteworks - Zentrum für klinische Studien Heidelberg
Heidelberg, 69115, Germany
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
Marburg, 35043, Germany
Zentrum für Rhinologie und Allergologie
Weisbaden, 65183, Germany
Polimedica PTG Kielce
Kielce, 25-355, Poland
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, 31-513, Poland
Malopolskie Centrum Alergologii
Krakow, 31-623, Poland
gab. 114, ul. inż. pilota Wigury
Lodz, 90-302, Poland
ETG Lublin
Lublin, 20-412, Poland
Centrum Alergologii Teresa Hofman Sp z.o.o.
Piła, 64-920, Poland
EMED Centrum Usług Medycznych
Rzeszów, 35-205, Poland
ClinMedica Research
Skierniewice, 96-100, Poland
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, 33-100, Poland
ETG Warszawa
Warsaw, 02-793, Poland
ALL-MED - Specjalistyczna Opieka Medyczna
Wroclaw, 53-201, Poland
Inje University Haeundae Paik Hospital
Busan, 48108, South Korea
B1F, Pharmacy department, Gachon University Gil Medical Center
Incheon, 21565, South Korea
Seoul National University Bundang Hospital
Seongnam-si, 13620, South Korea
Severance Hospital, Yonsei University Health System
Seoul, 03722, South Korea
Kyunghee University Hospital at Gangdong
Seoul, 05278, South Korea
Gangnam Severance Hospital 211
Seoul, 6273, South Korea
SMG-SNU Boramae Medical Center
Seoul, 7061, South Korea
Clinical trial Pharmacy
Seoul, 8308, South Korea
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)
Eli Lilly and Company
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- PARTICIPANT, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 25, 2024
First Posted
April 1, 2024
Study Start
April 26, 2024
Primary Completion (Estimated)
September 1, 2026
Study Completion (Estimated)
October 1, 2028
Last Updated
July 22, 2026
Record last verified: 2026-07
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, CSR
- Time Frame
- Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
- Access Criteria
- A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
Anonymized individual participant level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement.