Perennial Allergic Rhinitis (PAR)Phase 3NCT06339008
A Study of Lebrikizumab in Adult Participants With Perennial Allergic Rhinitis (PREPARED-1)
A Phase 3 study testing LY3650150 and Standard therapy for INCS in people with Perennial Allergic Rhinitis (PAR), run by Eli Lilly and Company at 74 sites in 6 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Perennial Allergic Rhinitis (PAR)
- What is being tested?
- LY3650150 and Standard therapy for INCS
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 74 sitesin 6 countries
- Study dates
- 26 Apr 2024to Oct 2028
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
74 sites in 6 countries.
74 sites in 6 countries
United States26 sites
Allergy Partners
Asheville, North Carolina, 28803
Circuit Clinical/Hudson-Essex Allergy
Belleville, New Jersey, 07109
Asthma and Allergy Center
Bellevue, Nebraska, 68123
Northwestern University
Chicago, Illinois, 60611
Bernstein Clinical Research Center, LLC
Cincinnati, Ohio, 45236
Asthma and Allergy Associates, PC
Colorado Springs, Colorado, 80907-6231
University of Missouri Hospital
Columbia, Missouri, 65212
AARA Research Center
Dallas, Texas, 75231
Allergy, Asthma & Sinus Center
Greenfield, Wisconsin, 53228
Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey, 08619
Smith Allergy and Asthma
Horseheads, New York, 14845
Allergy and Asthma Specialists Medical Group
Huntington Beach, California, 92648
310 Clinical Research
Inglewood, California, 90301
Kerrville Allergy and Asthma Associates
Kerrville, Texas, 78028
Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California, 92677
Bluegrass Allergy Research
Lexington, Kentucky, 40509
Clinical Research Institute
Minneapolis, Minnesota, 55402
Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania, 15241
Northwest Research Center
Portland, Oregon, 97202
Asthma Allergy Center of Chicago
River Forest, Illinois, 60305
Allergy and Asthma
San Diego, California, 92123
Allergy and Asthma Consultants
St Louis, Missouri, 63141
Allergy and Asthma Diagnostic Center
Tallahassee, Florida, 32308
University of South Florida
Tampa, Florida, 33613
Dr. Patrick Perin
Teaneck, New Jersey, 07666
Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan, 48197
China17 sites
Internal Medicine Building
Beijing, 100032
Department of Nasal Allergy
Beijing, 100730
The Third Xiangya Hospital of Central South University
Changsha, 410013
GCP Pharmacy
Guangzhou, 510000
Zhejiang People's Hospital
Hangzhou, 310014
Jingzhou Central Hospital
Jingzhou, 434020
The First Affiliated Hospital of Nanchang University
Nanchang, 330006
The Second Affiliated Hospital of Nanchang University
Nanchang, 330006
People's Hospital of Guangxi Zhuang Autonomous Region
Nanning, 530021
The First Affiliated Hospital of Guangxi Medical University
Nanning, 530021
Tongji Hospital
Shanghai, 200065
Outpatient building
Wuhan, 430014
Outpatient Department, Union Hospital
Wuhan, 430022
Renmin Hospital of Wuhan University
Wuhan, 430060
Northern Jiangsu People's Hospital
Yangzhou, 225001
Yangzhou University
Yangzhou, 225012
Zhongshan City People's Hospital
Zhongshan, 528403
Poland11 sites
Polimedica PTG Kielce
Kielce, 25-355
Centrum Medyczne Promed ul. Olszańska 5G
Krakow, 31-513
Malopolskie Centrum Alergologii
Krakow, 31-623
gab. 114, ul. inż. pilota Wigury
Lodz, 90-302
ETG Lublin
Lublin, 20-412
Centrum Alergologii Teresa Hofman Sp z.o.o.
Piła, 64-920
EMED Centrum Usług Medycznych
Rzeszów, 35-205
ClinMedica Research
Skierniewice, 96-100
Alergo-Med Specjalistyczna Przychodnia Lekarska Sp Z O.O.
Tarnów, 33-100
ETG Warszawa
Warsaw, 02-793
ALL-MED - Specjalistyczna Opieka Medyczna
Wroclaw, 53-201
South Korea8 sites
Inje University Haeundae Paik Hospital
Busan, 48108
B1F, Pharmacy department, Gachon University Gil Medical Center
Incheon, 21565
Seoul National University Bundang Hospital
Seongnam-si, 13620
Severance Hospital, Yonsei University Health System
Seoul, 03722
Kyunghee University Hospital at Gangdong
Seoul, 05278
Gangnam Severance Hospital 211
Seoul, 6273
SMG-SNU Boramae Medical Center
Seoul, 7061
Clinical trial Pharmacy
Seoul, 8308
Germany7 sites
Charité - Universitätsmedizin Berlin Klinik für Dermatologie
Berlin, 10117
Praxis für HNO und Allergologie
Dresden, 1139
Universitätsklinikum Carl Gustav Carus an der TU
Dresden, 1307
IKF Pneumologie
Frankfurt am Main, 60596
Siteworks - Zentrum für klinische Studien Heidelberg
Heidelberg, 69115
Universitätsklinik Marburg,Hals-, Nasen- und Ohrenklinik, Sektion Rhinologie und Allergologie
Marburg, 35043
Zentrum für Rhinologie und Allergologie
Weisbaden, 65183
Belgium5 sites
Hôpital Erasme, Service Pharmacie
Brussels, 1070
Pneumocare
Erpent, 5101
UZ Gent
Ghent, 9000
UZ Leuven, Pharmacy
Leuven, 3000
Hôpital de la Citadelle
Liège, 4000
About this study
Official title: 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.
- Conditions
- Perennial Allergic Rhinitis (PAR)
- Being tested
- LY3650150, Placebo, Standard therapy for INCS
- Medical subject headings
- Rhinitis, Allergic, Perennial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LY3650150Drug
Administered SC
PlaceboDrug
Administered SC
Standard therapy for INCSDrug
Administered as intranasal spray
| Study group | Role | What they receive |
|---|---|---|
| Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) | Experimental | Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS). Receives: Drug: LY3650150; Drug: Standard therapy for INCS |
| Lebrikizumab Q2W/every 8 weeks (Q8W) | Experimental | Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. Receives: Drug: LY3650150; Drug: Standard therapy for INCS |
| Placebo Q2W/Q4W | Placebo comparator | Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS. Receives: Drug: Placebo; Drug: Standard therapy for INCS |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline, Week 16
Secondary outcomes (7)
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).
Measured: 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)
Measured: 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).
Measured: 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).
Measured: Baseline, Week 56
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.
Measured: 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.
Measured: 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.
Measured: Baseline, Week 16
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2024
- Study start26 Apr 2024
- Primary completionSep 2026 (estimated)
- Study completionOct 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Perennial Allergic Rhinitis (PAR)Studies of the same condition, open and under way.
- More trials run by Eli Lilly and CompanyThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Eli Lilly and Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- 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), Study director, Eli Lilly and Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06339008
- Sponsor's protocol ID
- 18789
- Other IDs
- J2T-MC-KGBT, 2023-508817-18-00, 2023
- Status last verified
- Sep 2026
- First submitted
- 25 Mar 2024
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.