Lebrikizumab for Allergic Rhinitis

Recruiting at 94 trial locations

Overseen By Physicians interested in becoming principal investigators please contact

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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of lebrikizumab for treating perennial allergic rhinitis, which causes year-round stuffy or runny noses and sneezing. Participants will receive injections of either lebrikizumab or a placebo, along with standard nose sprays. It suits adults diagnosed with perennial allergic rhinitis who experience symptoms from indoor allergens. As a Phase 3 trial, this study represents the final step before FDA approval, allowing participants 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, 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 there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that lebrikizumab is generally safe for use. In past studies, patients using lebrikizumab experienced symptom improvements without major safety issues. However, researchers continue to study its long-term safety and effectiveness. Some participants have reported mild side effects, such as injection site reactions or headaches. Lebrikizumab is already approved for other conditions, suggesting it is reasonably safe. Prospective trial participants should consult a healthcare provider to understand the risks and benefits. ^{1 2 3 4 5}

Why are researchers excited about this study treatment for allergic rhinitis?

Unlike the standard treatments for allergic rhinitis, which often include antihistamines and intranasal corticosteroids, Lebrikizumab is unique because it targets a specific protein called interleukin-13 (IL-13). IL-13 plays a key role in allergic reactions and inflammation, so by specifically targeting this protein, Lebrikizumab may offer more precise control over symptoms. Researchers are excited about Lebrikizumab because it offers different dosing schedules, with the potential for a longer-lasting effect, allowing for less frequent dosing compared to traditional treatments. This could mean fewer injections and potentially improved convenience and adherence for patients.

What evidence suggests that lebrikizumab might be an effective treatment for allergic rhinitis?

Research has shown that lebrikizumab helps reduce symptoms of year-round allergies. Previous studies found that patients using lebrikizumab experience noticeable relief from allergy symptoms. The drug targets the immune system's response that causes allergies, reducing swelling. In this trial, participants will receive lebrikizumab in different dosing schedules: every 2 weeks or every 4 weeks, and another group will receive it every 2 weeks or every 8 weeks. Past research has shown that both dosing schedules of lebrikizumab lead to similar improvements in symptoms. This suggests that lebrikizumab could be a promising option for managing year-round allergies. ^{1 3 6 7 8}

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?

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 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 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

What Are the Treatments Tested in This Trial?

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.

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 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

Published Research Related to This Trial

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06339008

NCT06339008 | A Study of Lebrikizumab in Adult ... The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.

2. trials.lilly.com trials.lilly.com/en-US/trial/475755

A Study of Lebrikizumab in Adult Participants With ... - Lilly Trials The main purpose of this study is to evaluate the efficacy and safety of lebrikizumab in adult participants with perennial allergic rhinitis.

3. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK612749/

Clinical Review - Lebrikizumab (Ebglyss) - NCBI Bookshelf - NIH Systemic therapies had been previously received by 43% to 56% of patients, and 12% to 24% of patients had used phototherapy before enrolment in the trials.

4. synapse.patsnap.com synapse.patsnap.com/article/what-clinical-trials-have-been-conducted-for-lebrikizumab

What clinical trials have been conducted for Lebrikizumab? - In patients with perennial allergic rhinitis, lebrikizumab has shown efficacy in reducing allergy symptoms, with data indicating significant ...

5. orpdl.org orpdl.org/durm/meetings/meetingdocs/2025_10_02/finals/Ebglyss_NDE.pdf

Ebglyss™ (lebrikizumab-lbkz) injection, for subcutaneous use For the primary outcome and most secondary outcomes, symptom improvement was qualitatively similar for both dosing arms of lebrikizumab, although statistical ...

6. ncbi.nlm.nih.gov ncbi.nlm.nih.gov/books/NBK610231/

Lebrikizumab (Ebglyss) - NCBI Bookshelf - NIH The longer-term safety and efficacy of lebrikizumab from the RCTs and extension study is uncertain because of limitations with the data which included an ...

7. academic.oup.com academic.oup.com/bjd/article/193/5/876/8262125

Efficacy and safety of lebrikizumab in adult and adolescent ... The results showed that after 16 weeks, people on lebrikizumab had a greater improvement in AD symptoms than those on placebo. Their symptoms ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2024/761306s000lbledt.pdf

EBGLYSS (lebrikizumab-lbkz), injection, for subcutaneous use Available data on lebrikizumab-lbkz use in pregnant women are insufficient to evaluate for a drug-associated risk of major birth defects, miscarriage, or other ...