Lunsekimig for Asthma

(AIRPHRODITE Trial)

Recruiting at 142 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: ICS, LABA, LAMA, LTRA

Disqualifiers: New pulmonary disease, Smoking, Substance abuse, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: Unknown

Duration: 96 weeks

900 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called lunsekimig (an experimental drug) to determine its long-term safety and effectiveness for people with asthma. Participants will receive lunsekimig as an injection and must have completed previous related studies. This trial suits those with asthma who maintain stable medication routines, including inhaled corticosteroids (ICS) and other controllers like long-acting beta-agonists (LABA). Participants must have finished earlier studies with lunsekimig and be willing to continue study visits and procedures. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in asthma care.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop your current medications. However, you must have a stable background therapy of certain asthma medications to participate.

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

Research has shown that lunsekimig is generally safe for people. One study found that a single dose of lunsekimig was safe, reduced inflammation, and improved lung function in individuals with mild-to-moderate asthma. Another study examined the long-term use of lunsekimig in adults with moderate-to-severe asthma to assess its safety over time. These findings indicate that the treatment has been tested for safety in both short-term and long-term use. Although the treatment remains under study, these results provide some reassurance about its safety. ^{1 2 3 4 5}

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

Lunsekimig is unique because it offers a new approach for treating asthma by using a subcutaneous injection, which is different from the common inhalation methods like inhalers and nebulizers. Most asthma treatments, such as corticosteroids and bronchodilators, work by reducing inflammation or relaxing airway muscles. However, Lunsekimig could provide a more direct, potentially longer-lasting effect by targeting specific pathways involved in asthma. Researchers are excited about its potential to improve asthma management with possibly fewer side effects and more convenient dosing intervals.

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

Research shows that lunsekimig, the investigational treatment in this trial, targets two key areas, TSLP and IL-13, linked to asthma. These areas contribute to the inflammation that worsens asthma symptoms. Treatments focusing on these areas have shown promise in reducing asthma symptoms. Early results suggest that lunsekimig may help lower inflammation markers in the lungs, such as FeNO, which relates to asthma severity. This indicates that lunsekimig could effectively manage asthma symptoms by reducing inflammation. ^{1 2 3 6 7}

Are You a Good Fit for This Trial?

This trial is for adults with moderate-to-severe asthma who completed the DRI16762 study. They must be on a stable regimen of medium to high-dose inhaled corticosteroids and up to two other controller meds, just like in the previous study. Participants should agree to long-term follow-up, use contraception if applicable, and not be pregnant or donating gametes.

Inclusion Criteria

I am willing and able to follow the study's schedule and procedures.

I cannot become pregnant.

I am not pregnant or breastfeeding.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive a subcutaneous injection of lunsekimig according to established dosing interval

96 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Open-label extension

Participants may opt into continuation of treatment long-term

Long-term

What Are the Treatments Tested in This Trial?

Interventions

• Lunsekimig

Trial Overview The trial is testing Lunsekimig's long-term safety and effectiveness for those with moderate-to-severe asthma over a period of up to 96 weeks. It's an open-label extension meaning everyone gets Lunsekimig and knows it; there’s no placebo group.

How Is the Trial Designed?

Group I: Lunsekimig Experimental Treatment 1 Intervention

Participants will receive a subcutaneous injection of lunsekimig according to established dosing interval

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

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

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]

Citations

1. 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 ... These results demonstrate that amlitelimab has potential to improve key disease outcomes in asthma patients with continued unmet need. The ...

2. 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 ... Effect of existing asthma biologics and SAR443765 on FeNO at Day 29 ... Anti-IL-13 trials. SAR443765. –40.9 ppb. (90% CI: –55.4 to –26.4) ...

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

A first‐in‐human, single and multiple dose study of ... Anti‐TSLP and anti‐IL‐13 monospecific monoclonal antibodies have been successfully explored for the possible treatment of asthma and atopic ...

4. sanofi.com sanofi.com/en/media-room/press-releases/2023/2023-05-05-12-30-00-2662513

Press Release: New late-breaking data at ATS 2023 ... These results demonstrate proof-of-mechanism in asthma and are the first report of a novel biologic targeting both the TSLP and IL-13 pathways.

5. clinicaltrials.gov clinicaltrials.gov/study/NCT06676319

NCT06676319 | Study of Lunsekimig (SAR443765) ... The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with SC lunsekimig compared with placebo in male and female ...

6. 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.

7. 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.