RECRUITING

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

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

Quick Facts

Study Start:2024-04-26

Study Completion:2027-02

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT06339008

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.

Ages Eligible for Study:18 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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.	* 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.

Inclusion Criteria

Exclusion 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.

* 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.

Contacts and Locations

Study Contact

There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

CONTACT

1-317-615-4559

clinical_inquiry_hub@lilly.com

Principal Investigator

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 Locations (Sites)

Allergy and Asthma Specialists Medical Group

Huntington Beach, California, 92648

United States

310 Clinical Research

Inglewood, California, 90301

United States

Allergy & Asthma Associates of Southern California dba. Southern California Research

Laguna Niguel, California, 92677

United States

Allergy and Asthma

San Diego, California, 92123

United States

Asthma and Allergy Associates, PC

Colorado Springs, Colorado, 80907-6231

United States

Allergy and Asthma Diagnostic Center

Tallahassee, Florida, 32308

United States

University of South Florida

Tampa, Florida, 33613

United States

Northwestern University

Chicago, Illinois, 60611

United States

Asthma Allergy Center of Chicago

River Forest, Illinois, 60305

United States

Bluegrass Allergy Research

Lexington, Kentucky, 40509

United States

Respiratory Medicine Research Institute of Michigan, PLC

Ypsilanti, Michigan, 48197

United States

Clinical Research Institute

Minneapolis, Minnesota, 55402

United States

University of Missouri Hospital

Columbia, Missouri, 65212

United States

Allergy and Asthma Consultants

Saint Louis, Missouri, 63141

United States

Asthma and Allergy Center

Bellevue, Nebraska, 68123

United States

Circuit Clinical/Hudson-Essex Allergy

Belleville, New Jersey, 07109

United States

Circuit Clinical/Mercer Allergy and Pulmonary Associates

Hamilton, New Jersey, 08619

United States

Dr. Patrick Perin

Teaneck, New Jersey, 07666

United States

Smith Allergy and Asthma

Horseheads, New York, 14845

United States

Allergy Partners

Asheville, North Carolina, 28803

United States

Allergy Partners

Asheville, North Carolina, 28803

United States

Bernstein Clinical Research Center, LLC

Cincinnati, Ohio, 45236

United States

Northwest Research Center

Portland, Oregon, 97202

United States

Allergy and Clinical Immunology Associates

Pittsburgh, Pennsylvania, 15241

United States

AARA Research Center

Dallas, Texas, 75231

United States

Kerrville Allergy and Asthma Associates

Kerrville, Texas, 78028

United States

Allergy, Asthma & Sinus Center

Greenfield, Wisconsin, 53228

United States

Collaborators and Investigators

Sponsor: 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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2024-04-26

Study Completion Date2027-02

Study Record Updates

Study Start Date2024-04-26

Study Completion Date2027-02

Terms related to this study

Additional Relevant MeSH Terms

Perennial Allergic Rhinitis (PAR)