Lebrikizumab for Rhinosinusitis with Nasal Polyps

Recruiting at155 trial 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?

Lebrikizumab is unique because it targets IL-13, a protein involved in inflammation, which may offer a novel approach compared to other biologics like dupilumab, omalizumab, and mepolizumab that target different pathways in treating nasal polyps. ^{1 2 3 4 5}

Research Team

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 Overview The 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

Group I: Lebrikizumab every 2 weeks (Q2W)/ every 4 weeks (Q4W) Experimental Treatment 2 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 Treatment 2 Interventions

Lebrikizumab will be given as SC injection. Participants will receive background therapy with INCS.

Group III: Placebo Q2W/Q4W Placebo Group 2 Interventions

Placebo will be given as SC injection. Participants will receive background therapy with INCS.

Lebrikizumab is already approved in Canada for the following indications:

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

Who Is Running the Clinical Trial?

Eli Lilly and Company

Lead Sponsor

Trials

2,708

Recruited

3,720,000+

Dr. Daniel Skovronsky

Eli Lilly and Company

Chief Medical Officer since 2018

MD from Harvard Medical School

David A. Ricks

Eli Lilly and Company

Chief Executive Officer since 2017

BSc from Purdue University, MBA from Indiana University

Findings from Research

Biologics like dupilumab, omalizumab, and mepolizumab are effective add-on treatments for chronic rhinosinusitis with nasal polyposis, showing significant improvements in nasal polyp size, congestion, and sense of smell.

These biologics have received FDA approval for treating nasal polyposis, but further research is necessary to compare their efficacy and safety across different types of nasal polyposis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A review of phase III clinical trials of US FDA-approved biologic therapies for chronic rhinosinusitis with nasal polyposis. Lelegren, MJ., Son, SY., Han, JK., et al.[2022]

A review of 19 studies, including 8 randomized controlled trials, found that biologics like dupilumab, mepolizumab, and omalizumab significantly improve nasal polyp scores in patients with chronic rhinosinusitis with nasal polyps (CRSwNP).

Dupilumab has the most extensive data supporting its use and is one of the few biologics approved by the FDA for treating CRSwNP, indicating its efficacy and safety in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps. Koski, RR., Hill, L., Taavola, K.[2023]

In two difficult-to-treat cases of Aspirin exacerbated respiratory disease (AERD) with nasal polyps, treatment with the monoclonal anti-IgE antibody omalizumab led to successful control of the disease and symptoms after revision surgery.

Omalizumab presents a promising alternative treatment for chronic rhinosinusitis with nasal polyps, potentially reducing the need for systemic steroids and repeated surgeries.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[The efficacy of omalizumab in the treatment of chronic rhinosinusitis with nasal polyps: a discussion of 2 refractory cases]. Jandus, P., Harr, T., Soyka, MB., et al.[2019]

In a case study of three patients treated with omalizumab for asthma after nasal polypectomy, none experienced recurrence of nasal polyps, suggesting a potential benefit of the drug in preventing polyp regrowth.

One patient even showed regression of initial polyp return after starting omalizumab, supporting the idea that this medication could be effective for treating nasal polyposis, despite its current lack of authorization for this use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab a new prospective: a nasal polyposis. Cavaliere, C., Begvarfaj, E., Frati, F., et al.[2022]

Dupilumab, an IL-4 receptor antagonist, has shown significant efficacy in reducing the severity of chronic rhinosinusitis with nasal polyps, improving symptoms, polyp size, and overall quality of life in phase 3 trials.

The use of dupilumab also significantly decreased the need for systemic glucocorticosteroids and sinus surgeries, marking a promising advancement in the treatment of severe chronic rhinosinusitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics for chronic rhinosinusitis with nasal polyps. Bachert, C., Zhang, N., Cavaliere, C., et al.[2020]

References

1. England pubmed.ncbi.nlm.nih.gov

A review of phase III clinical trials of US FDA-approved biologic therapies for chronic rhinosinusitis with nasal polyposis. [2022]

2. United States pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Biologics for Chronic Rhinosinusitis With Nasal Polyps. [2023]

3. Switzerland pubmed.ncbi.nlm.nih.gov

[The efficacy of omalizumab in the treatment of chronic rhinosinusitis with nasal polyps: a discussion of 2 refractory cases]. [2019]

4. Italy pubmed.ncbi.nlm.nih.gov

Omalizumab a new prospective: a nasal polyposis. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Biologics for chronic rhinosinusitis with nasal polyps. [2020]