Lebrikizumab for Rhinosinusitis with Nasal Polyps
Recruiting in Palo Alto (17 mi)
+155 other locations
Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Eli Lilly and Company
Must be taking: Intranasal corticosteroids
Must not be taking: Biologics, Immunosuppressants
Disqualifiers: Recent surgery, Nasal tumor, others
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 Jurisdictions
Trial Summary
What is the purpose of this trial?
The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps treated with intranasal corticosteroids. The study will last about 18 months.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on certain biologic treatments or systemic immunosuppressants, you may need to stop them before joining the study.
How is the drug Lebrikizumab different from other treatments for nasal polyps?
Research Team
C1
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)
Principal Investigator
Eli Lilly and Company
Eligibility Criteria
Adults with chronic rhinosinusitis and nasal polyps who are currently being treated with intranasal corticosteroids can join this study. Specific details about who can or cannot participate were not provided, so interested individuals should contact the trial organizers for full eligibility criteria.Inclusion Criteria
Has a physician diagnosed you with chronic sinusitis with nasal polyps?
Have you taken systemic corticosteroids in the last 2 years for your nasal polyp symptoms? (oral or injection, ie. prednisone, dexamethasone, triamcinolone, etc.)
Exclusion Criteria
Have you ever used steroid nasal sprays for your nasal polyp symptoms? (ie. Flonase, Nasacort, Nasonex, Xhance)
Have you had prior surgery to remove your nasal polyps?
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Treatment
Participants receive lebrikizumab or placebo as subcutaneous injections alongside intranasal corticosteroids
24 weeks
Bi-weekly visits for injections
Follow-up
Participants are monitored for safety and effectiveness after treatment
4 weeks
Open-label extension (optional)
Participants may opt into continuation of treatment long-term
Long-term
Treatment Details
Interventions
- Lebrikizumab (Monoclonal Antibodies)
Trial OverviewThe trial is testing lebrikizumab (LY3650150) to see if it's effective and safe in treating adults with chronic rhinosinusitis and nasal polyps. Participants will either receive lebrikizumab or a placebo alongside standard therapy for an estimated duration of 18 months.
Participant Groups
3Treatment groups
Experimental Treatment
Placebo Group
Group I: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W)Experimental Treatment2 Interventions
Lebrikizumab will be given as Subcutaneous (SC) injection. Participants will receive background therapy with intranasal corticosteroids (INCS).
Group II: Lebrikizumab Q2W/every 8 weeks (Q8W)Experimental Treatment2 Interventions
Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.
Group III: Placebo Q2W/Q4WPlacebo Group2 Interventions
Placebo will be given as SC injection. Participants will receive background therapy with INCS.
Lebrikizumab is already approved in European Union, United States, Canada for the following indications:
🇪🇺 Approved in European Union as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg
🇺🇸 Approved in United States as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and children 12 years and older who weigh at least 88 pounds (40 kg)
🇨🇦 Approved in Canada as Ebglyss for:
- Moderate-to-severe atopic dermatitis in adults and adolescents 12 years and older with a body weight of at least 40 kg
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Richmond Ear Nose and ThroatRichmond, VA
Chesapeake Clinical Research, Inc.White Marsh, MD
Alamo ENT AssociatesSan Antonio, TX
Berkson MedicalMcKinney, TX
More Trial Locations
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Who Is Running the Clinical Trial?
Eli Lilly and Company
Lead Sponsor
Trials
2708
Patients Recruited
3,720,000+
References
A review of phase III clinical trials of US FDA-approved biologic therapies for chronic rhinosinusitis with nasal polyposis. [2022]Chronic rhinosinusitis with nasal polyposis is a heterogenous disease with complex underlying pathophysiologic mechanisms. Biologics have been proven to be an effective add-on therapeutic option in severe and/or refractory cases. Currently, dupilumab, omalizumab and mepolizumab have phase III data to support their use in these patients and have received approval from the United States Food and Drug Administration specifically for the treatment of nasal polyposis. Each of these biologics has shown its ability to reduce nasal polyp size and improve nasal congestion/obstruction and sense of smell, but additional research is needed to directly compare the efficacy and safety of the different biologic agents for different nasal polyposis endotypes.
Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps. [2023]Objective: To review published literature for biologic treatment of nasal polyps. Data Sources: PubMed search performed on February 16, 2022, using search terms: biologics, benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab AND nasal polyps, nasal polyposis, or chronic rhinosinusitis with nasal polyposis (CRSwNP). Inclusion criteria were English language, published randomized controlled trials, post hoc analyses, and meta-analyses evaluating biologics for nasal polyposis, with or without comorbid asthma, and no date limits. Additional studies were found through references of primary and tertiary literature. Study Selection and Data Extraction: Nineteen studies, including 8 randomized controlled trials, 2 meta-analyses, and 9 post hoc analyses, examined the efficacy and safety of biologics for nasal polyposis. Agents studied included benralizumab, dupilumab, mepolizumab, omalizumab, and reslizumab. Studies had similar inclusion (refractory and recurrent CRSwNP) and exclusion criteria. All studies included the use of an intranasal corticosteroid (mometasone or fluticasone) in addition to the biologic or placebo. The most commonly studied primary endpoint was change in endoscopic nasal polyp score. Data Synthesis: All studies, post hoc analyses, and meta-analyses found improvement in endoscopic, clinical, and/or radiographic endpoints with benralizumab, dupilumab, mepolizumab, omalizumab, or reslizumab in patients with CRSwNP with or without comorbid asthma. Dupilumab has the most published data. Dupilumab, mepolizumab, and omalizumab are the only biologics currently Food and Drug Administration-approved for CRSwNP. Conclusion: Biologics are beneficial for treating nasal polyps with or without comorbid asthma. The choice depends on patient and provider preference and insurance coverage.
[The efficacy of omalizumab in the treatment of chronic rhinosinusitis with nasal polyps: a discussion of 2 refractory cases]. [2019]Nasal polyposis is a specific phenotype of chronic rhinosinusitis (CRS). Some cases can be managed with topical and infrequent use of systemic steroids, while many patients require surgery. Despite postoperative, regular steroid administration, recurrences may be found especially in patients suffering from Aspirin exacerbated respiratory disease (AERD), a particularly severe form of CRS with polyps, asthma and non-steroid-anti-inflammatory-drug (NSAID) intolerance. We report two cases of difficult-to-treat AERD patients following revision surgery, treated with monoclonal anti-IgE antibody (omalizumab) and successful control of the disease and symptoms. Omalizumab may be a promising alternative in selected cases of CRS with nasal polyps to avoid overuse of systemic steroids and frustrating repetition of paranasal sinus surgeries.
Omalizumab a new prospective: a nasal polyposis. [2022]Omalizumab, a monoclonal antibody against IgE, may be effective on nasal polyps, but its use is not currently authorized to treat that disease. We report the cases of three patients who were given omalizumab for asthma after undergoing nasal surgical polypectomy. Although such procedure is frequently followed by polyp recurrence, none of the three patients developed this complication, and in one subject the regression of initial polyp return was registered after starting omalizumab. Our data support the hypothesis that omalizumab may be useful to treat nasal polyposis.
Biologics for chronic rhinosinusitis with nasal polyps. [2020]With the increasing recognition of the role of type 2 immune responses in chronic rhinosinusitis, its severity, recurrence, and comorbidities, several biologics targeting IL-4, IL-5, and IL-13 as well as IgE have been administered in small proof-of-concept studies. Recently, the first phase 3 trials have been reported with dupilumab, an IL-4 receptor antagonist, demonstrating a significant and clinically relevant reduction of the disease burden from polyp size and sinus involvement to symptoms and smell; these changes consecutively led to an important increase in quality of life. Finally, the biologic versus placebo treatment reduced the need for systemic glucocorticosteroids and sinus surgery significantly and clinically meaningfully. Dupilumab today is registered for the treatment of chronic rhinosinusitis with nasal polyps in Europe and the United States. Within a year, 2 further phase 3 trials with omalizumab and mepolizumab will be reported. With this development, without any doubt, a new era for the treatment of severe uncontrolled chronic rhinosinusitis with nasal polyps has begun. Questions on the indication of the biologics, the selection of patients, and finally criteria for monitoring the efficacy in individual patients need to be urgently answered, and care pathways need to be established integrating the current standard of care including surgery.