Actively Recruiting
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-controlled Study Evaluating the Efficacy and Safety of Lebrikizumab in Adults With Perennial Allergic Rhinitis
Led by Eli Lilly and Company · Updated on 2026-04-20
450
Participants Needed
77
Research Sites
108 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the safety and effectiveness of lebrikizumab in adults with perennial allergic rhinitis, a condition involving year-round nasal allergy symptoms. This phase 3 clinical trial aims to assess how well lebrikizumab works when given alongside standard intranasal corticosteroid therapy. The study is sponsored by Eli Lilly and Company and lasts up to 29.5 months for each participant. Participants will receive lebrikizumab or a matching placebo through subcutaneous injections on different schedules, either every 2 weeks, every 4 weeks, or every 8 weeks, combined with ongoing intranasal corticosteroid use. The trial includes multiple treatment groups with random assignment and double-blind masking to compare the effects of lebrikizumab against placebo while all participants continue their background nasal spray therapy. During the study, participants will have their nasal symptoms evaluated at baseline and at various points, including week 16 and week 56, using symptom scores and quality of life questionnaires. Researchers will monitor changes in nasal symptoms, quality of life, and postnasal drip. Safety and any adverse effects will also be tracked throughout the study duration, with follow-up visits and assessments as scheduled.
CONDITIONS
Brief Title
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Physician-diagnosed perennial allergic rhinitis (PAR)
- Positive skin prick test or positive serum antigen-specific IgE for indoor allergens
- Clinical symptoms linked to positive perennial allergen test at study entry
- Participants with stable asthma in prior 3 months using permitted asthma treatment
- Participants with known dermatographism may participate if serum antigen-specific IgE is positive
You will not qualify if you...
- Prior use of lebrikizumab
- Current use of subcutaneous or sublingual allergy immunotherapy; discontinued immunotherapy less than 3 years ago
- Use of rescue medication during the run-in period
- Treatment with biologics or systemic immunosuppressants (including JAK inhibitors) before baseline visit
- History of seasonal worsening of allergic rhinitis expected during key study periods
- Anticipated major changes in daily environmental exposure
- History of recurrent acute or chronic sinusitis
- Female who is pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 16 weeks
Participants receive lebrikizumab or placebo injections along with standard intranasal corticosteroid therapy to manage perennial allergic rhinitis symptoms.
Regular visits for assessments during treatment period
Duration - Up to 40 weeks after treatment
Participants are monitored for long-term effects and symptom changes after treatment ends.
Visits up to Week 56 for outcome assessments
Trial Site Locations
Total: 77 locations
1
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, United States, 92648
Actively Recruiting
2
310 Clinical Research
Inglewood, California, United States, 90301
Actively Recruiting
3
Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California, United States, 92677
Actively Recruiting
4
Allergy and Asthma
San Diego, California, United States, 92123
Actively Recruiting
5
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, United States, 80907-6231
Actively Recruiting
6
Allergy and Asthma Diagnostic Center
Tallahassee, Florida, United States, 32308
Not Yet Recruiting
7
University of South Florida
Tampa, Florida, United States, 33613
Not Yet Recruiting
8
Northwestern University
Chicago, Illinois, United States, 60611
Not Yet Recruiting
9
Asthma Allergy Center of Chicago
River Forest, Illinois, United States, 60305
Actively Recruiting
10
Bluegrass Allergy Research
Lexington, Kentucky, United States, 40509
Actively Recruiting
11
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, United States, 48197
Actively Recruiting
12
Clinical Research Institute
Minneapolis, Minnesota, United States, 55402
Actively Recruiting
13
University of Missouri Hospital
Columbia, Missouri, United States, 65212
Not Yet Recruiting
14
Allergy and Asthma Consultants
St Louis, Missouri, United States, 63141
Actively Recruiting
15
Asthma and Allergy Center
Bellevue, Nebraska, United States, 68123
Actively Recruiting
16
Circuit Clinical/Hudson-Essex Allergy
Belleville, New Jersey, United States, 07109
Actively Recruiting
17
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, United States, 08619
Actively Recruiting
18
Dr. Patrick Perin
Teaneck, New Jersey, United States, 07666
Actively Recruiting
19
Smith Allergy and Asthma
Horseheads, New York, United States, 14845
Actively Recruiting
20
Allergy Partners
Asheville, North Carolina, United States, 28803
Actively Recruiting
21
Allergy Partners
Asheville, North Carolina, United States, 28803
Not Yet Recruiting
22
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, United States, 45236
Actively Recruiting
23
Northwest Research Center
Portland, Oregon, United States, 97202
Actively Recruiting
24
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, United States, 15241
Actively Recruiting
25
AARA Research Center
Dallas, Texas, United States, 75231
Actively Recruiting
26
Kerrville Allergy and Asthma Associates
Kerrville, Texas, United States, 78028
Actively Recruiting
27
Allergy, Asthma & Sinus Center
Greenfield, Wisconsin, United States, 53228
Actively Recruiting
28
Hôpital Erasme, Service Pharmacie
Brussels, Belgium, 1070
Not Yet Recruiting
29
Pneumocare
Erpent, Belgium, 5101
Actively Recruiting
30
UZ Gent
Ghent, Belgium, 9000
Not Yet Recruiting
31
UZ Leuven, Pharmacy
Leuven, Belgium, 3000
Actively Recruiting
32
Hôpital de la Citadelle
Liège, Belgium, 4000
Actively Recruiting
33
Internal Medicine Building
Beijing, China, 100032
Actively Recruiting
34
Department of Nasal Allergy
Beijing, China, 100730
Actively Recruiting
35
The Third Xiangya Hospital of Central South University
Changsha, China, 410013
Actively Recruiting
36
GCP Pharmacy
Guangzhou, China, 510000
Actively Recruiting
37
GCP Pharmacy
Guangzhou, China, 510000
Actively Recruiting
38
Zhejiang People's Hospital
Hangzhou, China, 310014
Actively Recruiting
39
Jingzhou Central Hospital
Jingzhou, China, 434020
Actively Recruiting
40
The First Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
41
The Second Affiliated Hospital of Nanchang University
Nanchang, China, 330006
Actively Recruiting
42
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, China, 530021
Not Yet Recruiting
43
The First Affiliated Hospital of Guangxi Medical University
Nanning, China, 530021
Not Yet Recruiting
44
Tongji Hospital
Shanghai, China, 200065
Actively Recruiting
45
Outpatient building
Wuhan, China, 430014
Actively Recruiting
46
Outpatient Department, Union Hospital
Wuhan, China, 430022
Actively Recruiting
47
Renmin Hospital of Wuhan University
Wuhan, China, 430060
Actively Recruiting
48
Northern Jiangsu People's Hospital
Yangzhou, China, 225001
Actively Recruiting
49
Yangzhou University
Yangzhou, China, 225012
Actively Recruiting
50
Zhongshan City People's Hospital
Zhongshan, China, 528403
Not Yet Recruiting
51
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
Berlin, Germany, 10117
Actively Recruiting
52
Praxis für HNO und Allergologie
Dresden, Germany, 1139
Actively Recruiting
53
Universitätsklinikum Carl Gustav Carus an der TU
Dresden, Germany, 1307
Not Yet Recruiting
54
IKF Pneumologie
Frankfurt am Main, Germany, 60596
Not Yet Recruiting
55
Siteworks - Zentrum für klinische Studien Heidelberg
Heidelberg, Germany, 69115
Actively Recruiting
56
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
Marburg, Germany, 35043
Actively Recruiting
57
Zentrum für Rhinologie und Allergologie
Weisbaden, Germany, 65183
Actively Recruiting
58
Polimedica PTG Kielce
Kielce, Poland, 25-355
Actively Recruiting
59
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, Poland, 31-513
Actively Recruiting
60
Malopolskie Centrum Alergologii
Krakow, Poland, 31-623
Actively Recruiting
61
gab. 114, ul. inż. pilota Wigury
Lodz, Poland, 90-302
Actively Recruiting
62
ETG Lublin
Lublin, Poland, 20-412
Actively Recruiting
63
Centrum Alergologii Teresa Hofman Sp z.o.o.
Piła, Poland, 64-920
Actively Recruiting
64
EMED Centrum Usług Medycznych
Rzeszów, Poland, 35-205
Actively Recruiting
65
ClinMedica Research
Skierniewice, Poland, 96-100
Actively Recruiting
66
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, Poland, 33-100
Actively Recruiting
67
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, Poland, 33-100
Actively Recruiting
68
ETG Warszawa
Warsaw, Poland, 02-793
Actively Recruiting
69
ALL-MED - Specjalistyczna Opieka Medyczna
Wroclaw, Poland, 53-201
Actively Recruiting
70
Inje University Haeundae Paik Hospital
Busan, South Korea, 48108
Actively Recruiting
71
B1F, Pharmacy department, Gachon University Gil Medical Center
Incheon, South Korea, 21565
Not Yet Recruiting
72
Seoul National University Bundang Hospital
Seongnam-si, South Korea, 13620
Actively Recruiting
73
Severance Hospital, Yonsei University Health System
Seoul, South Korea, 03722
Not Yet Recruiting
74
Kyunghee University Hospital at Gangdong
Seoul, South Korea, 05278
Actively Recruiting
75
Gangnam Severance Hospital 211
Seoul, South Korea, 6273
Actively Recruiting
76
SMG-SNU Boramae Medical Center
Seoul, South Korea, 7061
Not Yet Recruiting
77
Clinical trial Pharmacy
Seoul, South Korea, 8308
Not Yet Recruiting
Research Team
T
Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
P
Physicians interested in becoming principal investigators please contact
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
Frequently Asked Questions
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