Lunsekimig for Asthma

(AIRLYMPUS Trial)

Recruiting at 149 trial locations

Overseen By Trial Transparency email recommended (Toll free for US & Canada)

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Disqualifiers: Severe lung diseases, Immunosuppression, Active TB, others

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

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 13

Duration: 52 weeks

1147 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called lunsekimig, an experimental drug, to determine its effectiveness for asthma. The goal is to assess the safety and efficacy of this treatment when added to usual asthma care, compared to a placebo (an inactive look-alike treatment). The trial seeks participants who have had mild-to-moderate asthma for over a year and have experienced at least one asthma attack in the past year. Participants should not qualify for biologic treatments and should not have other severe lung diseases like COPD. As a Phase 2 trial, this research measures the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important asthma research.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

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

Research has shown that lunsekimig has generally been well-tolerated in earlier studies. One study found that a single dose of lunsekimig was safe and improved lung function in people with mild-to-moderate asthma. Another study on long-term use demonstrated its safety for adults with moderate-to-severe asthma.

This treatment is currently being tested in a Phase 2 trial. While some evidence of safety exists, more information is needed to fully understand its tolerability. Participants in this trial will help gather important data on its safety and effectiveness. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for asthma?

Unlike the standard asthma treatments that often involve inhalers or oral medications focusing on symptom relief, Lunsekimig offers something different. It is administered as a subcutaneous (SC) injection, which could mean a more convenient dosing schedule—every four weeks—compared to daily inhalers. Researchers are excited because Lunsekimig may offer a new mechanism of action, potentially targeting underlying causes of asthma rather than just managing symptoms. This could lead to more effective long-term control of asthma, providing hope for patients who struggle with current therapies.

What evidence suggests that lunsekimig might be an effective treatment for asthma?

Research has shown that lunsekimig, which participants in this trial may receive, may help reduce asthma symptoms. Users experienced fewer asthma attacks and required less emergency medication. Early results suggest that this treatment improves lung function by targeting specific parts of the body involved in asthma. This is especially promising for those unable to use other advanced treatments. While more research is needed, these early findings suggest that lunsekimig could be a helpful option for managing asthma.

Are You a Good Fit for This Trial?

This trial is for adults aged 18 to 80 with high-risk asthma who aren't eligible for biologic treatments. Participants will be involved in the study for about a year, with up to 18 visits.

Inclusion Criteria

Were you diagnosed with asthma by a doctor at least 12 months ago?

Have you been using a combination inhaler that contains a steroid (such as fluticasone) plus a long-acting bronchodilator every day?

In the last 12 months, have you had at least one asthma attack that needed systemic corticosteroids, an ER visit, or hospitalization?

Exclusion Criteria

Have you been diagnosed with chronic lung disease (eg, COPD or interstitial lung disease) other than asthma?

Are you currently taking biologic medications like Dupilumab (Dupixent) or Benralizumab (Fasenra) for your asthma?

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of lunsekimig or placebo every 4 weeks

52 weeks

13 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

8-12 weeks

Long-term follow-up (optional)

Participants may transition into a long-term study for continued monitoring

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Lunsekimig

Trial Overview

The trial is testing Lunsekimig as an add-on therapy compared to a placebo. It's double-blind, meaning neither participants nor researchers know who gets the real treatment or placebo during the study.

How Is the Trial Designed?

Group I: Lunsekimig Experimental Treatment 5 Interventions

Participants will receive lunsekimig (SC injection) every 4 weeks

Group II: Placebo Placebo Group 5 Interventions

Participants will receive placebo (SC injection) every 4 weeks

Lunsekimig is already approved in China for the following indications:

Approved in China as Lunsekimig for:

• High-risk asthma in adults
• Moderate to severe asthma in adults

Who Is Running the Clinical Trial?

Sanofi

Lead Sponsor

Trials

2,246

Recruited

4,085,000+

Paul Hudson

Sanofi

Chief Executive Officer since 2019

Degree in Economics from Manchester Metropolitan University

Christopher Corsico

Sanofi

Chief Medical Officer

MD from Cornell University, MPH in Chronic Disease Epidemiology from Yale University

Published Research Related to This Trial

Interleukin (IL)-13 and IL-4 are key targets for treating TH2-mediated asthma, as they play significant roles in the disease's inflammatory processes, including IgE synthesis and airway remodeling.

Anti-IL-13 treatments, like lebrikizumab, and anti-IL-4 treatments, such as dupilumab, have shown promise in reducing asthma severity and exacerbations, but identifying specific biomarkers for patient response is crucial for optimizing these therapies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Critical Evaluation of Anti-IL-13 and Anti-IL-4 Strategies in Severe Asthma. Bagnasco, D., Ferrando, M., Varricchi, G., et al.[2022]

New leukotriene modulators, such as montelukast, zafirlukast, and zileuton, have been developed to improve asthma control by reducing symptoms and the need for rescue medications.

These medications are effective for patients with mild intermittent to moderate persistent asthma, as they help improve pulmonary function and overall management of the disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comprehensive asthma management: guidelines for clinicians. Kemp, JP.[2019]

In a study of 35 patients with allergic rhinitis and asthma, the leukotriene receptor antagonist zafirlukast significantly reduced symptoms of both conditions after 2 weeks of treatment during the grass pollen season.

Zafirlukast improved nasal resistance and ciliary beat frequency, while also decreasing eosinophil counts in nasal lavage fluid, indicating its potential effectiveness in managing inflammation associated with these respiratory conditions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of zafirlukast on bronchial asthma and allergic rhinitis. Piatti, G., Ceriotti, L., Cavallaro, G., et al.[2021]

Dupilumab significantly improves lung function and asthma control in patients with moderate to severe asthma, as evidenced by better forced expiratory volume and asthma control questionnaire scores over 12 and 24 weeks in 13 trials.

The treatment is generally safe, showing no significant increase in adverse events compared to placebo, although it was associated with higher blood eosinophil levels.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Dupilumab efficacy and safety in patients with moderate to severe asthma: A systematic review and meta-analysis. Zaazouee, MS., Alwarraqi, AG., Mohammed, YA., et al.[2022]

Leukotriene modifiers, a new class of asthma medications, have been shown to effectively improve pulmonary function, reduce symptoms, and decrease the need for rescue medications in patients with asthma, based on controlled clinical trials.

These medications are generally safe and well tolerated, with side effects similar to placebo, although there is a noted association with Churg-Strauss Syndrome, which may be related to reducing corticosteroid doses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Recent advances in the management of asthma using leukotriene modifiers. Kemp, JP.[2021]

In a 13-week study involving 454 participants aged 12 to 68, zafirlukast significantly reduced daytime asthma symptoms, nighttime awakenings, and beta2-agonist use compared to placebo, indicating its efficacy in managing asthma.

Zafirlukast also improved quality of life across various domains, with a safety profile similar to that of placebo, suggesting it is a well-tolerated treatment option for patients with moderate asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Zafirlukast improves asthma symptoms and quality of life in patients with moderate reversible airflow obstruction. Nathan, RA., Bernstein, JA., Bielory, L., et al.[2021]

Leukotriene receptor antagonists (LTRAs) like montelukast and zafirlukast are effective in treating asthma, showing bronchodilating and anti-inflammatory properties that complement inhaled corticosteroids, especially in patients with moderate asthma.

Clinical studies indicate that LTRAs can improve asthma control and allow for reduced corticosteroid dosages, with montelukast providing similar benefits to inhaled corticosteroids in patients with mild persistent asthma over a 6-week treatment period.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Leukotriene receptor antagonists in the treatment of asthma: an update. Balzano, G., Fuschillo, S., Gaudiosi, C.[2019]

The study of CAT-354, a human anti-IL-13 antibody, involved 23 adults with asthma and demonstrated a linear pharmacokinetic profile, with a half-life of 12-17 days and low clearance, indicating it can be safely administered in multiple doses.

Most adverse events were mild to moderate and unrelated to the medication, suggesting that CAT-354 has an acceptable safety profile for treating asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A phase 1 study evaluating the pharmacokinetics, safety and tolerability of repeat dosing with a human IL-13 antibody (CAT-354) in subjects with asthma. Singh, D., Kane, B., Molfino, NA., et al.[2021]

Anti-interleukin 13 therapies significantly reduced the rate of asthmatic exacerbations and improved peak expiratory flow (PEF) in adult asthmatics, based on a systematic review of 8 studies involving 957 patients.

These therapies did not significantly improve lung function measures like FEV1 or reduce eosinophil levels, indicating that while they are effective in reducing exacerbations, their overall impact on asthma control may be limited.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Efficacy and Safety of Antiinterleukin 13, a Monoclonal Antibody, in Adult Patients With Asthma: A Systematic Review and Meta-Analysis. Luo, J., Liu, D., Liu, CT.[2022]

Anti-IL-13 monoclonal antibodies, specifically lebrikizumab and tralokinumab, significantly improve asthma management in uncontrolled asthma patients, as shown in a meta-analysis of five studies with 3476 participants, leading to reduced asthma exacerbations, improved lung function (FEV1), and better quality of life scores.

The safety profile of anti-IL-13 treatments is comparable to placebo, with no significant increase in adverse events, and patients with high periostin levels may benefit the most from this treatment, suggesting that periostin could be a useful biomarker for identifying responsive patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A meta-analysis of anti-interleukin-13 monoclonal antibodies for uncontrolled asthma. Li, H., Wang, K., Huang, H., et al.[2020]

Two monoclonal antibodies targeting IL-13, tralokinumab and lebrikizumab, were tested in multiple studies for severe asthma but did not meet their primary efficacy endpoints, despite showing safety with no serious adverse events reported.

In contrast, dupilumab, which blocks both IL-4 and IL-13 signaling, has been effective in reducing asthma exacerbations and improving lung function, suggesting that targeting both pathways may be more beneficial than targeting IL-13 alone.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Intriguing Role of Interleukin 13 in the Pathophysiology of Asthma. Marone, G., Granata, F., Pucino, V., et al.[2020]

Tralokinumab, a monoclonal antibody targeting IL-13, has been evaluated in four randomized, placebo-controlled trials for its efficacy and safety in treating severe, uncontrolled asthma, showing promising results.

The pivotal trials (STRATOS 1 and STRATOS 2) identified specific patient subgroups that may benefit most from tralokinumab, while additional studies explored its potential to reduce reliance on oral corticosteroids and assessed long-term safety in Japanese patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tralokinumab for the treatment of severe, uncontrolled asthma: the ATMOSPHERE clinical development program. Panettieri, RA., Wang, M., Braddock, M., et al.[2020]

Citations

1.

publications.ersnet.org

publications.ersnet.org/content/erj/65/4/2401461

A proof-of-mechanism trial in asthma with lunsekimig, a ...

A single dose of lunsekimig was well tolerated, significantly suppressed T2 inflammation and improved lung function in mild-to-moderate asthma.

2.

sanofistudies.com

sanofistudies.com/cwout/CW-V9DEXS//za/en/listing/312979/long-term-safety-and-efficacy-5/

Long-term Safety and Efficacy Evaluation of Lunsekimig ...

This study investigates the long-term safety and efficacy of an investigational medication in adults with moderate-to-severe asthma.

3.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC11196376/

A first‐in‐human, single and multiple dose study of ...

Lunsekimig (SAR443765) is the first bispecific NANOBODY® molecule in development for asthma and blocks both TSLP and IL‐13. NANOBODY® molecules ...

4.

sanofi.com

sanofi.com/en/media-room/press-releases/2025/2025-04-15-05-00-00-3061368

Press Release: Sanofi's respiratory pipeline advances with ...

Sanofi's respiratory pipeline advances with new data in asthma and plans for new clinical studies in COPD.

5.

congress.sanofimedical.com

congress.sanofimedical.com/s3fs-public/2023-05/ATS%202023%20NANOBODY%20SAR443765%20Oral%20presentation%20SUBMITTED%2005-08-23%20%281%29.pdf?VersionId=64mgz.FmLyHTdN_Yh0H27qkYOzAclsjn

Targeting of TSLP and IL-13 by the novel NANOBODY ...

The primary outcome was safety, and change in FeNO from baseline ... Anti-IL-13 trials. SAR443765. –40.9 ppb. (90% CI: –55.4 to –26.4) ...