Actively Recruiting
A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Lebrikizumab in Chronic Rhinosinusitis With Nasal Polyps Using Intranasal Corticosteroids
Led by Eli Lilly and Company · Updated on 2026-06-03
510
Participants Needed
194
Research Sites
43 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This research aims to evaluate the effectiveness and safety of lebrikizumab in people with chronic rhinosinusitis and nasal polyps who are also treated with intranasal corticosteroids. The study is a Phase 3 clinical trial lasting about 18 months and includes participants aged 12 years and older. It is designed to understand how lebrikizumab works alongside standard nasal spray treatment for this condition. Participants will receive lebrikizumab through subcutaneous injections every 2, 4, or 8 weeks, depending on the assigned group. All participants continue using their regular intranasal corticosteroid sprays during the study. Adolescents aged 12 to under 18 years will receive open-label lebrikizumab injections every 2 or 4 weeks. There is also a placebo group receiving injections without the active drug but with the same nasal spray background treatment. During the study, participants will be monitored regularly for changes in nasal congestion and nasal polyp size over 24 weeks, using participant reports and endoscopic examinations. Other assessments include sinus imaging, lung function tests, smell loss severity, postnasal drip symptoms, and quality of life questionnaires. Safety and adherence will be closely observed throughout the 18-month study period to ensure participant well-being.
CONDITIONS
Brief Title
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Physician-diagnosed chronic rhinosinusitis with bilateral nasal polyps
- Prior systemic corticosteroid treatment within last 2 years or prior nasal polyp surgery or both
- Endoscopic nasal polyp score of at least 5 out of 8, with minimum score of 2 in each nasal cavity at screening and baseline
- Symptoms ongoing for at least 8 weeks before screening, including moderate or severe nasal congestion at screening and randomization
- At least one other symptom such as partial or total loss of smell or nasal discharge
- Stable asthma for at least 3 months before screening using permitted asthma treatment
- Adolescents aged 12 to under 18 years weighing at least 40 kg at first visit
You will not qualify if you...
- Previous treatment with lebrikizumab
- Need for rescue medication or nasal polyp surgery during screening or run-in period
- Recent allergen immunotherapy not on stable dose
- Biologic treatments for CRSwNP, asthma, or atopic dermatitis within 4 months or 5 half-lives before screening
- Biologic or systemic immunosuppressant treatment for inflammatory or autoimmune disease before baseline visit
- Sinus or nasal surgery within 6 months prior to screening
- Prior nasal or sinus surgery altering nasal structure preventing polyp score assessment
- Conditions affecting endpoint assessment such as severe nasal septal deviation, antrochoanal polyps, acute sinus infections, ongoing medicamentosa, certain granulomatous or genetic syndromes, nasal tumors, or fungal rhinosinusitis
- Loss of smell from COVID or other causes unrelated to CRSwNP
- Forced expiratory volume in 1 second (FEV1) less than or equal to 50% predicted at screening
- Female participants who are pregnant, breastfeeding, or planning pregnancy or breastfeeding during the study
Research Team
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Trial questions or participation questions: 1-877-CTLILLY (1-877-285-4559) or
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Physicians interested in becoming principal investigators please contact
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