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

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. The study will last about 18 months

Study Overview

• Status: Not yet recruiting
• Conditions: Perennial Allergic Rhinitis (PAR)
• Intervention / Treatment: Drug: Placebo; Drug: LY3650150; Drug: Standard therapy for INCS

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or; Phone Number: 1-317-615-4559; Email: ClinicalTrials.gov@lilly.com

Study Locations

• United States
  • California
    • California City, California, United States, 92691
      • Southern California Research
      • Contact: Phone Number: 949-276-4917
      • Principal Investigator: Warner Carr
    • Inglewood, California, United States, 90301
      • 310 Clinical Research
      • Contact: Phone Number: 310-878-2636
      • Principal Investigator: Soheil Hekmat
    • San Diego, California, United States, 92123
      • Allergy and Asthma
      • Contact: Phone Number: 143 858-268-2368
      • Principal Investigator: Bob Geng
  • Colorado
    • Colorado Springs, Colorado, United States, 80907-6231
      • Asthma and Allergy Associates, PC
      • Contact: Phone Number: 719-473-8330 x5
      • Principal Investigator: Luke Webb
  • Florida
    • Aventura, Florida, United States, 33180
      • Florida Center For Allergy & Asthma Care Aventura
      • Principal Investigator: Jaime Landman
      • Contact: Phone Number: 305-931-7583
  • Kentucky
    • Lexington, Kentucky, United States, 40509
      • Bluegrass Allergy Research
      • Principal Investigator: William Greisner
      • Contact: Phone Number: 859-303-7191
  • Massachusetts
    • Greenfield, Massachusetts, United States, 53228
      • Allergy, Asthma & Sinus Center
      • Contact: Phone Number: 414-529-8519
      • Principal Investigator: Gary Steven
  • Michigan
    • Ypsilanti, Michigan, United States, 48197
      • Respiratory Medicine Research Institute of Michigan, PLC
      • Contact: Phone Number: 734-528-0477
      • Principal Investigator: Jeffrey Leflein
  • Minnesota
    • Minneapolis, Minnesota, United States, 55402
      • Clinical Research Institute
      • Contact: Phone Number: 378 612-333-2200
      • Principal Investigator: Gary Berman
  • Missouri
    • Saint Louis, Missouri, United States, 63141
      • Allergy and Asthma Consultants
      • Contact: Phone Number: 314-991-5117
      • Principal Investigator: Robert Onder
  • New Jersey
    • Teaneck, New Jersey, United States, 07666
      • Dr. Patrick Perin
      • Principal Investigator: Patrick Perin
  • Ohio
    • Cincinnati, Ohio, United States, 45236
      • Bernstein Clinical Research Center, LLC
      • Contact: Phone Number: 314-991-5117
      • Principal Investigator: David Bernstein
  • Oregon
    • Portland, Oregon, United States, 97202
      • Northwest Research Center
      • Contact: Phone Number: 503-238-6233
      • Principal Investigator: Anthony Montanaro
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15241
      • Allergy and Clinical Immunology Associates
      • Principal Investigator: Michael Palumbo
      • Contact: Phone Number: 116 412-833-4051
  • Texas
    • Kerrville, Texas, United States, 78028
      • Kerrville Allergy and Asthma Associates
      • Principal Investigator: Dale Mohar
      • Contact: Phone Number: 830-896-1433
    • Waco, Texas, United States, 76712
      • Allergy Asthma Research Institute
      • Principal Investigator: Niran Amar
      • Contact: Phone Number: 254-741-8151

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion 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.

Exclusion Criteria:

• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W); Lebrikizumab will be given as a subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).	Drug: LY3650150; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray
Experimental: Lebrikizumab Q2W/every 8 weeks (Q8W); Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.	Drug: LY3650150; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray
Placebo Comparator: Placebo Q2W/Q4W; Placebo matching Lebrikizumab will be given as an SC injection. Participants will receive background therapy with INCS.	Drug: Placebo; Administered SC; Drug: Standard therapy for INCS; Administered as intranasal spray

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Baseline, Week 16

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mean CFBL in Rhinoconjunctivitis Quality of Life Questionnaire Standardized Version [RQLQ(S)] 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).	Baseline, Week 16
Mean CFBL in RQLQ(S) 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)	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.	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.	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.	Baseline, Week 16

Collaborators and Investigators

• Sponsor: Eli Lilly and Company
• Investigators: Study Director: 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), Eli Lilly and Company

Study record dates

Study Major Dates

• Study Start (Estimated): April 12, 2024
• Primary Completion (Estimated): May 30, 2025
• Study Completion (Estimated): May 1, 2026

Study Registration Dates

• First Submitted: March 25, 2024
• First Submitted That Met QC Criteria: March 25, 2024
• First Posted (Actual): April 1, 2024

Study Record Updates

• Last Update Posted (Estimated): April 15, 2024
• Last Update Submitted That Met QC Criteria: April 11, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Infections; Respiratory Tract Infections; Respiratory Tract Diseases; Immune System Diseases; Hypersensitivity, Immediate; Otorhinolaryngologic Diseases; Respiratory Hypersensitivity; Hypersensitivity; Nose Diseases; Rhinitis; Rhinitis, Allergic; Rhinitis, Allergic, Perennial
• Other Study ID Numbers: 18789; J2T-MC-KGBT (Other Identifier: Eli Lilly and Company); 2023-508817-18-00 (Other Identifier: EU Clinical Trial Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: 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.
• IPD Sharing Time Frame: Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting.
• IPD Sharing Access Criteria: A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL; SAP; CSR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No