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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Perennial Allergic Rhinitis (PAR)
• Intervention / Treatment: Drug: Placebo; Drug: LY3650150; Drug: Standard therapy for INCS

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

Study Locations

• Belgium
  • Brussels, Belgium, 1070
    • Hôpital Erasme, Service Pharmacie
  • Erpent, Belgium, 5101
    • Pneumocare
  • Ghent, Belgium, 9000
    • UZ Gent
  • Leuven, Belgium, 3000
    • UZ Leuven, Pharmacy
  • Liège, Belgium, 4000
    • Hôpital de la Citadelle
• China
  • Beijing, China, 100032
    • Internal Medicine Building
  • Beijing, China, 100730
    • Department of Nasal Allergy
  • Changsha, China, 410013
    • The Third Xiangya Hospital of Central South University
  • Guangzhou, China, 510000
    • GCP Pharmacy
  • Hangzhou, China, 310014
    • Zhejiang People's Hospital
  • Jingzhou, China, 434020
    • Jingzhou Central Hospital
  • Nanchang, China, 330006
    • The First Affiliated Hospital of Nanchang University
  • Nanchang, China, 330006
    • The Second Affiliated Hospital Of Nanchang University
  • Nanning, China, 530021
    • People's Hospital of Guangxi Zhuang Autonomous Region
  • Nanning, China, 530021
    • The First Affiliated Hospital of Guangxi Medical University
  • Shanghai, China, 200065
    • Tongji Hospital
  • Wuhan, China, 430060
    • Renmin Hospital of Wuhan University
  • Wuhan, China, 430014
    • Outpatient building
  • Wuhan, China, 430022
    • Outpatient Department, Union Hospital
  • Yangzhou, China, 225001
    • Northern Jiangsu People's Hospital
  • Yangzhou, China, 225012
    • Yangzhou University
  • Zhongshan, China, 528403
    • Zhongshan City People's Hospital
• Germany
  • Berlin, Germany, 10117
    • Charité - Universitätsmedizin Berlin Klinik für Dermatologie
  • Dresden, Germany, 1307
    • Universitätsklinikum Carl Gustav Carus an der TU
  • Dresden, Germany, 1139
    • Praxis für HNO und Allergologie
  • Frankfurt am Main, Germany, 60596
    • IKF Pneumologie
  • Heidelberg, Germany, 69115
    • Siteworks - Zentrum für klinische Studien Heidelberg
  • Marburg, Germany, 35043
    • Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
  • Weisbaden, Germany, 65183
    • Zentrum für Rhinologie und Allergologie
• Poland
  • Kielce, Poland, 25-355
    • Polimedica PTG Kielce
  • Krakow, Poland, 31-513
    • Centrum Medyczne Promed ul. Olszańska 5G
  • Krakow, Poland, 31-623
    • Malopolskie Centrum Alergologii
  • Lodz, Poland, 90-302
    • gab. 114, ul. inż. pilota Wigury
  • Lublin, Poland, 20-412
    • ETG Lublin
  • Piła, Poland, 64-920
    • Centrum Alergologii Teresa Hofman Sp z.o.o.
  • Rzeszów, Poland, 35-205
    • EMED Centrum Usług Medycznych
  • Skierniewice, Poland, 96-100
    • Clinmedica Research
  • Tarnów, Poland, 33-100
    • Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
  • Warsaw, Poland, 02-793
    • ETG Warszawa
  • Wroclaw, Poland, 53-201
    • ALL-MED - Specjalistyczna Opieka Medyczna
• South Korea
  • Busan, South Korea, 48108
    • Inje University Haeundae Paik Hospital
  • Incheon, South Korea, 21565
    • B1F, Pharmacy department, Gachon University Gil Medical Center
  • Seongnam-si, South Korea, 13620
    • Seoul National University Bundang Hospital
  • Seoul, South Korea, 03722
    • Severance Hospital, Yonsei University Health System
  • Seoul, South Korea, 05278
    • Kyunghee University Hospital at Gangdong
  • Seoul, South Korea, 6273
    • Gangnam Severance Hospital 211
  • Seoul, South Korea, 7061
    • SMG-SNU Boramae Medical Center
  • Seoul, South Korea, 8308
    • Clinical trial Pharmacy
• United States
  • California
    • Huntington Beach, California, United States, 92648
      • Allergy and Asthma Specialists Medical Group
    • Inglewood, California, United States, 90301
      • 310 Clinical Research
    • Laguna Niguel, California, United States, 92677
      • Allergy & Asthma Associates of Southern California dba. Southern California Research
    • San Diego, California, United States, 92123
      • Allergy and Asthma
  • Colorado
    • Colorado Springs, Colorado, United States, 80907-6231
      • Asthma and Allergy Associates, PC
  • Florida
    • Tallahassee, Florida, United States, 32308
      • Allergy and Asthma Diagnostic Center
    • Tampa, Florida, United States, 33613
      • University of South Florida
  • Illinois
    • Chicago, Illinois, United States, 60611
      • Northwestern University
    • River Forest, Illinois, United States, 60305
      • Asthma Allergy Center of Chicago
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Allergy Research
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
  • Missouri
    • Columbia, Missouri, United States, 65212
      • University of Missouri Hospital
    • St Louis, Missouri, United States, 63141
      • Allergy and Asthma Consultants
  • Nebraska
    • Bellevue, Nebraska, United States, 68123
      • Asthma and Allergy Center
  • New Jersey
    • Belleville, New Jersey, United States, 07109
      • Circuit Clinical/Hudson-Essex Allergy
    • Hamilton, New Jersey, United States, 08619
      • Circuit Clinical/Mercer Allergy and Pulmonary Associates
    • Teaneck, New Jersey, United States, 07666
      • Dr. Patrick Perin
  • New York
    • Horseheads, New York, United States, 14845
      • Smith Allergy and Asthma
  • North Carolina
    • Asheville, North Carolina, United States, 28803
      • Allergy Partners
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
  • Oregon
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
  • Texas
    • Dallas, Texas, United States, 75231
      • AARA Research Center
    • Kerrville, Texas, United States, 78028
      • Kerrville Allergy and Asthma Associates
  • Wisconsin
    • Greenfield, Wisconsin, United States, 53228
      • Allergy, Asthma & Sinus Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

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 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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).	Drug: LY3650150; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W); Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.	Drug: LY3650150; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray
Placebo Comparator: Placebo Q2W/Q4W; Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.	Drug: Placebo; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean CFBL in TNSS at Week 4	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 4
Mean CFBL in TNSS at Week 56	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 56
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] Activities Domain at Week 16	The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).	Baseline, Week 16
Mean CFBL in RQLQ(S) Activities Domain at Week 56	The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment)	Baseline, Week 56
Mean CFBL in RQLQ(S) Total Score at Week 16	The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).	Baseline, Week 16
Mean CFBL in RQLQ(S) Total Score at Week 56	The RQLQ includes 28 questions (completed between 10-15 min). Participants are asked to recall their experiences during the previous week and to respond to each question on a 7-point scale. The RQLQ score ranges from 0 to 6 (0 = no impairment, 6 = severe impairment).	Baseline, Week 56
Mean CFBL in Postnasal Drip Score at Week 16	Postnasal drip is mucus drainage down the throat, as part of their Allergic Rhinitis (AR), will be rated by participants using a 4-point scale, where 0 corresponds to no symptoms and 3 corresponds to severe symptoms. Study participants are asked to record the severity of their postnasal drip, at its worst, for the previous 24 hours.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: 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 record dates

Study Major Dates

• Study Start (Actual): April 26, 2024
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): October 1, 2028

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Actual): July 22, 2026
• Last Update Submitted That Met QC Criteria: July 21, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Immune System Diseases; Respiratory Tract Diseases; Respiratory Hypersensitivity; Hypersensitivity, Immediate; Hypersensitivity; Nose Diseases; Otorhinolaryngologic Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial; Health Services Administration; Health Care Quality, Access, and Evaluation; Quality of Health Care; Quality Indicators, Health Care; Standard of Care
• Other Study ID Numbers: 18789; J2T-MC-KGBT (Other Identifier: Eli Lilly and Company); 2023-508817-18-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing 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.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No