Perennial Allergic Rhinitis (PAR) Clinical Trial
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
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
| 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. |
| 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 |
| Lead Sponsor | Collaborator |
|---|---|
| Eli Lilly and Company |
United States,
| 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 |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT01632540 -
Effectiveness of Beclomethasone Dipropionate Nasal Aerosol for Perennial Allergic Rhinitis
|
N/A |