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Purpose

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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Sex
All
Accepts 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.

Study Design

Phase
Phase 3
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
Double (Participant, Investigator)

Arm Groups

ArmDescriptionAssigned Intervention
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

Recruiting Locations

Allergy and Asthma Specialists Medical Group
Huntington Beach, California 92648
Contact:
714-848-8585

310 Clinical Research
Inglewood, California 90301
Contact:
310-878-2636

Allergy & Asthma Associates of Southern California dba. Southern California Research
Laguna Niguel, California 92677
Contact:
949-276-4917

Allergy and Asthma
San Diego, California 92123
Contact:
858-268-2368 ext. 143

Asthma and Allergy Associates, PC
Colorado Springs, Colorado 80907-6231
Contact:
719-473-8330 x5

Asthma Allergy Center of Chicago
River Forest, Illinois 60305
Contact:
708-695-4259

Bluegrass Allergy Research
Lexington, Kentucky 40509
Contact:
859-303-7191

Respiratory Medicine Research Institute of Michigan, PLC
Ypsilanti, Michigan 48197
Contact:
734-528-0477

Clinical Research Institute
Minneapolis, Minnesota 55402
Contact:
612-333-2200 ext 378

Allergy and Asthma Consultants
St Louis, Missouri 63141
Contact:
314-991-5117

Asthma and Allergy Center
Bellevue, Nebraska 68123
Contact:
402-592-2055

Circuit Clinical/Hudson-Essex Allergy
Belleville, New Jersey 07109

Circuit Clinical/Mercer Allergy and Pulmonary Associates
Hamilton, New Jersey 08619
Contact:
201-401-0713

Dr. Patrick Perin
Teaneck, New Jersey 07666

Smith Allergy and Asthma
Horseheads, New York 14845
Contact:
607-463-2223

Allergy Partners
Asheville, North Carolina 28803
Contact:
828-348-7047

Bernstein Clinical Research Center, LLC
Cincinnati, Ohio 45236
Contact:
314-991-5117

Northwest Research Center
Portland, Oregon 97202
Contact:
503-238-6233

Allergy and Clinical Immunology Associates
Pittsburgh, Pennsylvania 15241
Contact:
412-833-4051 Ext 116

AARA Research Center
Dallas, Texas 75231
Contact:
214-365-0365

Kerrville Allergy and Asthma Associates
Kerrville, Texas 78028
Contact:
830-896-1433

Allergy, Asthma & Sinus Center
Greenfield, Wisconsin 53228
Contact:
414-529-8519

More Details

Status
Recruiting
Sponsor
Eli Lilly and Company

Study Contact

Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
1-317-615-4559
LillyTrials@Lilly.com

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.