Lebrikizumab for Rhinosinusitis with Nasal Polyps

Recruiting at 212 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

Age: 18+

Sex: Any

Travel: May Be Covered

Trial Phase: Phase 3

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) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

510 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of lebrikizumab, administered as a shot, for individuals with chronic rhinosinusitis and nasal polyps who already use nasal steroid sprays. It compares lebrikizumab to a placebo (a non-active substance) to determine which better improves symptoms. The trial seeks participants with persistent nasal congestion and other symptoms, such as loss of smell or runny nose, for at least eight weeks, and who have previously used treatments like steroid pills or undergone nasal polyp surgery. As a Phase 3 trial, this study is the final step before FDA approval, offering participants a chance to contribute to the potential availability of a new treatment.

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.

Is there any evidence suggesting that lebrikizumab is likely to be safe for humans?

Research has shown that lebrikizumab is generally well-tolerated. In earlier trials, some patients experienced mild to moderate side effects, such as injection site reactions and headaches. These side effects are common with many injected treatments. So far, no major safety issues have emerged. Since this trial is in a later stage, a substantial amount of safety information is already available, indicating that lebrikizumab was relatively safe in earlier testing. However, individual experiences may vary with any treatment. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Unlike the standard treatments for nasal polyps, which typically include intranasal corticosteroids (INCS) and sometimes surgery, lebrikizumab offers a novel approach by targeting the interleukin-13 (IL-13) pathway, a key player in the inflammation process associated with nasal polyps. Researchers are excited about lebrikizumab because it specifically blocks IL-13, potentially reducing inflammation more effectively than current options. Additionally, lebrikizumab is administered as a subcutaneous injection, which might provide a more convenient dosing schedule compared to daily nasal sprays. This targeted mechanism of action and unique delivery method could offer a promising alternative for individuals struggling with nasal polyps.

What evidence suggests that lebrikizumab might be an effective treatment for nasal polyps?

Research shows that lebrikizumab might help reduce stuffy noses and shrink nasal polyps in people with chronic rhinosinusitis. Previous studies found that it can improve symptoms by targeting a specific protein involved in inflammation. This protein, interleukin-13 (IL-13), plays a key role in causing swelling and congestion. Early findings suggest that blocking IL-13 with lebrikizumab can help people breathe better and reduce the size of polyps over time. In this trial, participants will receive either lebrikizumab or a placebo. While more research is needed, initial results are promising for relieving symptoms related to nasal polyps. ^{1 2 3 4 6}

Who Is on the Research Team?

Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 8 AM - 8 PM Eastern time (UTC/GMT - 5 hours, EST)

Principal Investigator

Eli Lilly and Company

Are You a Good Fit for This Trial?

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?

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

Interventions

• Lebrikizumab

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.

How Is the Trial Designed?

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 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

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

Published Research Related to This Trial

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06338995

NCT06338995 | A Study of Lebrikizumab (LY3650150) in ... The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps ...

2. trials.lilly.com trials.lilly.com/en-US/trial/472335

A Study of Lebrikizumab (LY3650150) in Adult ... - Lilly Trials The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps ...

3. connect.careboxhealth.com connect.careboxhealth.com/en-US/trial/listing/472335

A Study of Lebrikizumab (LY3650150) in Adult Participants ... The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and ...

4. trialstoday.org trialstoday.org/trial/NCT06338995

A Study of Lebrikizumab (LY3650150) in Adult Participants ... The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps.

5. clinicaltrials.eu clinicaltrials.eu/trial/study-on-lebrikizumab-for-adults-with-chronic-rhinosinusitis-and-nasal-polyps-using-intranasal-corticosteroids/

Study on Lebrikizumab for Adults with Chronic ... The purpose of the study is to see how well Lebrikizumab works in reducing nasal congestion and the size of nasal polyps over a period of 24 weeks.

6. clinicaltrials.icts.uci.edu clinicaltrials.icts.uci.edu/trial/NCT06338995

A Study of Lebrikizumab (LY3650150) in Adult Participants ... The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with chronic rhinosinusitis and nasal polyps.