Actively Recruiting

Phase 3
Age: 18Years +
All Genders
NCT06339008

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

Led by Eli Lilly and Company · Updated on 2026-04-20

450

Participants Needed

77

Research Sites

231 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Physician-diagnosed perennial allergic rhinitis (PAR).
  • Positive skin prick test with indoor allergens and/or positive serum antigen-specific IgE for indoor allergens \u22650.70 kU/L using a validated assay.
  • Clinical symptoms at study entry linked to positive perennial allergen test.
  • Participants with known or identified dermatographism may participate if they have a positive serum antigen-specific IgE test.
  • Participants with stable asthma for at least 3 months prior to screening using permitted regular asthma treatment.
Not Eligible

You will not qualify if you...

  • Previous treatment with lebrikizumab.
  • Currently receiving allergy immunotherapy (subcutaneous or sublingual); discontinuation must be at least 3 years prior.
  • Received rescue medication during the run-in period.
  • Prior treatment with biologics or systemic immunosuppressants including Janus Kinase inhibitors for inflammatory or autoimmune diseases before baseline.
  • Any current or prior use of biologics for asthma or atopic dermatitis.
  • Use of B cell-depleting biologics like rituximab within 6 months.
  • Use of other biologics within 5 half-lives or 8 weeks, whichever is longer.
  • Use of systemic immunosuppressants including JAK inhibitors within 4 weeks prior to baseline.
  • History of seasonal worsening of allergic rhinitis expected during specific study periods.
  • Anticipated significant changes in daily environmental exposure.
  • Known history of recurrent acute or chronic sinusitis.
  • Female participants who are 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

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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

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Research Team

T

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or

CONTACT

P

Physicians interested in becoming principal investigators please contact

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

DOUBLE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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