Lebrikizumab for Allergic Rhinitis

Recruiting at 67 trial locations

Overseen By There may be multiple sites in this clinical trial 1-877-CTLILLY (1-877-285-4559) or

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Eli Lilly and Company

Must not be taking: Biologics, Immunosuppressants

Disqualifiers: Immunotherapy, Sinusitis, Pregnancy, 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: 56 weeks

450 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on allergen immunotherapy or have used certain biologics or systemic immunosuppressants recently. It's best to discuss your specific medications with the trial team.

Is Lebrikizumab safe for humans?

Monoclonal antibodies, like Lebrikizumab, are generally considered well tolerated and relatively safe in patients with allergic rhinitis, though some people may experience mild skin reactions like urticaria (hives). ^{1 2 3 4 5}

How is the drug Lebrikizumab different from other treatments for allergic rhinitis?

Lebrikizumab is a monoclonal antibody that targets interleukin-13 (IL-13), a protein involved in inflammation, which makes it different from traditional treatments like antihistamines and corticosteroids that do not specifically target this pathway. This targeted approach may offer a novel way to manage allergic rhinitis by directly addressing the underlying inflammatory process. ^{6 7 8 9 10}

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 perennial allergic rhinitis. The study will last about 18 months

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

This trial is for adults with year-round nasal allergies. Participants should have a history of symptoms or a positive allergy test. Specific details on who can't join are not provided, but typically those with other significant health issues or taking conflicting medications would be excluded.

Inclusion Criteria

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 must complete their eDiaries 4 out of 7 days every week in the 2 weeks prior to randomization visit (baseline)

For women of childbearing potential (WOCBP), highly effective contraceptive use should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. WOCBP and women not of childbearing potential (WNOCBP) may participant in this study

Exclusion Criteria

Anticipates significant changes in their daily environmental exposure for >2 consecutive weeks within the 2 weeks preceding Week 16 or within the 4 weeks preceding Week 56

Has a history of chronic alcohol abuse, intravenous drug abuse, or other illicit drug abuse within the 2 years prior to screening

I have a significantly crooked nasal septum.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive lebrikizumab or placebo as a subcutaneous injection every 2, 4, or 8 weeks, with background therapy of intranasal corticosteroids

56 weeks

Regular visits for injections and assessments

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Lebrikizumab

Trial Overview The study tests lebrikizumab (LY3650150), given as an injection under the skin (SC), to see if it's effective and safe in treating perennial allergic rhinitis over approximately 13 months.

Participant Groups

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

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

Group III: Placebo Q2W/Q4W Placebo Group 2 Interventions

Placebo matching Lebrikizumab will be given as an 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

Findings from Research

Monoclonal antibodies are generally well tolerated and considered safe for treating allergic rhinitis, based on a systematic review of 12 studies involving over 2600 patients.

While adverse events were not statistically significant overall, urticaria was identified as a notable risk, indicating that specific hypersensitive reactions should be monitored closely during treatment.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. Lin, Y., Wang, W., Zhu, Z., et al.[2023]

Omalizumab is an effective treatment for moderate to severe allergic asthma and allergic rhinitis, significantly improving asthma control and quality of life while reducing the need for inhaled corticosteroids and rescue medications in patients poorly controlled by standard treatments.

The drug works by binding to IgE, preventing it from triggering allergic responses, and has been well tolerated in patients, although long-term safety beyond 52 weeks requires further study.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab: a monoclonal anti-IgE antibody. Belliveau, PP.[2018]

A meta-analysis of nine randomized controlled trials involving 1,764 patients showed that omalizumab significantly reduces symptoms of allergic rhinitis compared to a placebo, indicating its efficacy in treating this condition.

The study found no significant difference in adverse events between patients treated with omalizumab and those receiving placebo, suggesting that omalizumab is a safe option for managing allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of omalizumab for the treatment of allergic rhinitis:Meta-analysis of randomized clinical trials]. Qiu, X., Wang, HT.[2018]

In a randomized controlled trial involving 69 participants, Ibudilast was found to be more effective than loratadine in improving symptoms of steroid-resistant allergic rhinitis, with significant improvements observed at 3, 7, and 14 days (P<0.05).

Ibudilast demonstrated a good safety profile, as no complications were reported during the study, making it a recommended treatment option for patients who do not respond to steroids.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

[Clinical research of Ibudilast on treating the steroid resistant allergic rhinitis]. Luo, H., Tao, Z., Yan, N., et al.[2013]

Omalizumab, a monoclonal antibody that targets IgE, significantly improves asthma symptoms and reduces the frequency of asthma exacerbations in allergic asthmatic patients, as well as enhances their quality of life.

In children with allergic asthma, omalizumab not only improves health-related quality of life but also allows for significant reductions in inhaled corticosteroid dosages, with a favorable safety profile showing few adverse events compared to placebo.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Omalizumab. Easthope, S., Jarvis, B.[2018]

Leukotriene receptor antagonists have shown some effectiveness in treating allergic rhinitis, being more effective than placebo but not outperforming nonsedating antihistamines and being less effective than intranasal corticosteroids.

Despite their expected mechanism of action suggesting they should significantly improve nasal congestion, clinical studies indicate they do not provide better relief than antihistamines, and their unique role in treating allergic rhinitis remains unclear.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacotherapy for allergic rhinitis: a critical review of leukotriene receptor antagonists compared with other treatments. Nathan, RA.[2007]

Omalizumab, a humanized Anti-IgE monoclonal antibody, has been shown to significantly improve symptoms of allergic rhinitis by reducing the need for antiallergic medications and is effective in patients undergoing specific immunotherapy.

Dupilumab, an Anti-IL-4/IL-13 biologic, significantly enhances quality of life in patients with perennial allergic rhinitis, as indicated by improved scores on the sino-nasal Outcome Test (SNOT-22).

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Biologics in allergic rhinitis. Bayar Muluk, N., Cingi, C.[2023]

Leukotriene receptor antagonists, such as montelukast and zafirlukast, show mixed results as standalone treatments for allergic rhinitis, with some studies indicating benefits while others do not.

These medications may be more effective when used alongside standard treatments for allergic rhinitis, and it is considered safe to add them if symptoms persist, highlighting the need for further large-scale studies to identify which patients benefit most.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukotriene receptor antagonists in the treatment of allergic rhinitis. Maynard, ML., Ernst, ME.[2021]

In a study of 705 participants with seasonal allergic rhinitis, intranasal fluticasone propionate (FP200QD) was found to be significantly more effective than oral montelukast (MON10QD) in relieving both daytime and nighttime nasal symptoms over a 15-day treatment period.

Both treatments were well tolerated, but FP200QD showed superior results across all measured symptoms, including nasal congestion, itching, rhinorrhea, and sneezing, indicating it may be the preferred first-line therapy for allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. Ratner, PH., Howland, WC., Arastu, R., et al.[2022]

Topical nasal corticosteroids are more effective than oral antihistamines for reducing rhinitis symptoms in asthma patients, and they also help relieve symptoms of acute rhinosinusitis faster than antibiotics alone.

Omalizumab, a monoclonal anti-immunoglobulin E antibody, significantly reduces nasal symptoms in patients with ragweed allergic rhinitis, with 70.7% of patients reporting good or excellent treatment outcomes compared to 40.8% in the placebo group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Therapy in the management of the rhinitis/asthma complex. Greenberger, PA.[2021]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Adverse Events for Monoclonal Antibodies in Patients with Allergic Rhinitis: A Systematic Review and Meta-Analysis of Randomized Clinical Trials. [2023]

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

Omalizumab: a monoclonal anti-IgE antibody. [2018]

3. China pubmed.ncbi.nlm.nih.gov

[Safety and efficacy of omalizumab for the treatment of allergic rhinitis:Meta-analysis of randomized clinical trials]. [2018]

4. China pubmed.ncbi.nlm.nih.gov

[Clinical research of Ibudilast on treating the steroid resistant allergic rhinitis]. [2013]

5. New Zealand pubmed.ncbi.nlm.nih.gov

Omalizumab. [2018]

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

Pharmacotherapy for allergic rhinitis: a critical review of leukotriene receptor antagonists compared with other treatments. [2007]

7. Italy pubmed.ncbi.nlm.nih.gov

Biologics in allergic rhinitis. [2023]

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

Leukotriene receptor antagonists in the treatment of allergic rhinitis. [2021]

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

Fluticasone propionate aqueous nasal spray provided significantly greater improvement in daytime and nighttime nasal symptoms of seasonal allergic rhinitis compared with montelukast. [2022]

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

Therapy in the management of the rhinitis/asthma complex. [2021]