RECRUITING

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

Description

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months

Study Overview

Study Details

Study overview

The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis. The study will last about 18 months

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

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

Condition
Perennial Allergic Rhinitis (PAR)
Intervention / Treatment

-

Contacts and Locations

California City

Southern California Research, California City, California, United States, 92691

Inglewood

310 Clinical Research, Inglewood, California, United States, 90301

San Diego

Allergy and Asthma, San Diego, California, United States, 92123

Colorado Springs

Asthma and Allergy Associates, PC, Colorado Springs, Colorado, United States, 80907-6231

Aventura

Florida Center For Allergy & Asthma Care Aventura, Aventura, Florida, United States, 33180

Lexington

Bluegrass Allergy Research, Lexington, Kentucky, United States, 40509

Ypsilanti

Respiratory Medicine Research Institute of Michigan, PLC, Ypsilanti, Michigan, United States, 48197

Minneapolis

Clinical Research Institute, Minneapolis, Minnesota, United States, 55402

Saint Louis

Allergy and Asthma Consultants, Saint Louis, Missouri, United States, 63141

Teaneck

Dr. Patrick Perin, Teaneck, New Jersey, United States, 07666

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Physician-diagnosed PAR.
  • * Has a positive skin prick test (SPT) with indoor allergens and/or positive antigen-specific serum immunoglobulin E (IgE) for indoor allergens ≥0.70 kU/L, utilizing a validated assay (central laboratory).
  • * A dermatographic participant who has a known history of dermatographism or identified during the SPT may participate in this study with a positive serum IgE test.
  • * Participants who have concomitant asthma must be stable in the 3 months prior to screening using permitted regular asthma treatment.
  • * Have received a dose of lebrikizumab.
  • * Is currently on allergen immunotherapy. However, individuals who discontinued subcutaneous or sublingual immunotherapy (SCIT/SLIT) for ≥3 years prior to randomization are eligible, if they were not on a maintenance allergen immunotherapy (AIT) regimen.
  • * Have received treatment with any rescue medication during the screening and/or run-in period.
  • * Have received treatment with any biologic or systemic immunosuppressants for inflammatory disease or autoimmune disease prior to the baseline visit:
  • 1. B cell-depleting biologics, including rituximab, within 6 months.
  • 2. other biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  • 3. Systemic immunosuppressants 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 4 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.

Ages Eligible for Study

18 Years to

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

No

Collaborators and Investigators

Eli Lilly and Company,

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST), STUDY_DIRECTOR, Eli Lilly and Company

Study Record Dates

2026-05