Ireland
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Active, not recruiting Phase 3

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

NCT06339008 · tracked via the Priya Life Science South Korea tracker
Phase
Phase 3
Started
2024-04-26
Last updated
2026-09-24

Condition(s) studied

Perennial Allergic Rhinitis (PAR)

Investigational drug(s) / intervention(s)

LY3650150 →PlaceboStandard therapy for INCS

LY3650150: Administered SC

Placebo: Administered SC

Standard therapy for INCS: Administered as intranasal spray

Study 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Mean Change From Baseline (CFBL) in Total Nasal Symptom Score (TNSS) at Week 16 — Baseline, 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.

Trial sites (74)

FacilityCityRegionStatus
Allergy and Asthma Specialists Medical Group Huntington Beach California
310 Clinical Research Inglewood California
Allergy & Asthma Associates of Southern California dba. Southern California Research Laguna Niguel California
Allergy and Asthma San Diego California
Asthma and Allergy Associates, PC Colorado Springs Colorado
Allergy and Asthma Diagnostic Center Tallahassee Florida
University of South Florida Tampa Florida
Northwestern University Chicago Illinois
Asthma Allergy Center of Chicago River Forest Illinois
Bluegrass Allergy Research Lexington Kentucky
Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan
Clinical Research Institute Minneapolis Minnesota
University of Missouri Hospital Columbia Missouri
Allergy and Asthma Consultants St Louis Missouri
Asthma and Allergy Center Bellevue Nebraska
Circuit Clinical/Hudson-Essex Allergy Belleville New Jersey
Circuit Clinical/Mercer Allergy and Pulmonary Associates Hamilton New Jersey
Dr. Patrick Perin Teaneck New Jersey
Smith Allergy and Asthma Horseheads New York
Allergy Partners Asheville North Carolina
Bernstein Clinical Research Center, LLC Cincinnati Ohio
Northwest Research Center Portland Oregon
Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania
AARA Research Center Dallas Texas
Kerrville Allergy and Asthma Associates Kerrville Texas
Allergy, Asthma & Sinus Center Greenfield Wisconsin
Hôpital Erasme, Service Pharmacie Brussels Belgium
Pneumocare Erpent Belgium
UZ Gent Ghent Belgium
UZ Leuven, Pharmacy Leuven Belgium
Hôpital de la Citadelle Liège Belgium
Internal Medicine Building Beijing China
Department of Nasal Allergy Beijing China
The Third Xiangya Hospital of Central South University Changsha China
GCP Pharmacy Guangzhou China
Zhejiang People's Hospital Hangzhou China
Jingzhou Central Hospital Jingzhou China
The First Affiliated Hospital of Nanchang University Nanchang China
The Second Affiliated Hospital of Nanchang University Nanchang China
People's Hospital of Guangxi Zhuang Autonomous Region Nanning China

+ 34 more sites — see the full list on the official registry below.

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06339008 on ClinicalTrials.gov ↗ ← All trials in South Korea