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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT06339008
Other study ID # 18789
Secondary ID J2T-MC-KGBT2023-
Status Recruiting
Phase Phase 3
First received
Last updated
Start date April 26, 2024
Est. completion date May 2026

Study information

Verified date May 2024
Source Eli Lilly and Company
Contact There may be multiple sites in this clinical trial 1-877-CTLILLY
Phone 1-317-615-4559
Email ClinicalTrials.gov@lilly.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Recruiting
Enrollment 450
Est. completion date May 2026
Est. primary completion date May 2025
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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 Design


Related Conditions & MeSH terms


Intervention

Drug:
LY3650150
Administered SC
Placebo
Administered SC
Standard therapy for INCS
Administered as intranasal spray

Locations

Country Name City State
United States Florida Center For Allergy & Asthma Care Aventura Aventura Florida
United States Southern California Research California City California
United States Bernstein Clinical Research Center, LLC Cincinnati Ohio
United States Asthma and Allergy Associates, PC Colorado Springs Colorado
United States AARA Research Center Dallas Texas
United States Allergy, Asthma & Sinus Center Greenfield Wisconsin
United States 310 Clinical Research Inglewood California
United States Smith Allergy and Asthma Ithaca New York
United States Kerrville Allergy and Asthma Associates Kerrville Texas
United States Bluegrass Allergy Research Lexington Kentucky
United States Clinical Research Institute Minneapolis Minnesota
United States Allergy and Clinical Immunology Associates Pittsburgh Pennsylvania
United States Northwest Research Center Portland Oregon
United States Allergy and Asthma Consultants Saint Louis Missouri
United States Allergy and Asthma San Diego California
United States Dr. Patrick Perin Teaneck New Jersey
United States Allergy Asthma Research Institute Waco Texas
United States Respiratory Medicine Research Institute of Michigan, PLC Ypsilanti Michigan

Sponsors (1)

Lead Sponsor Collaborator
Eli Lilly and Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 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
Secondary 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
Secondary 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
Secondary 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
Secondary 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
See also
  Status Clinical Trial Phase
Completed NCT01632540 - Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis N/A