SAR443765 for Asthma

(AIRCULES Trial)

Not currently recruiting at 295 trial locations

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

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Sanofi

Must be taking: ICS therapy

Disqualifiers: COPD, Smoking, Tuberculosis, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 48 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called SAR443765, designed to help people with moderate-to-severe asthma. The study aims to determine the safety and effectiveness of this treatment when added to existing asthma medications. Participants will receive varying doses of the treatment or a placebo for comparison. Individuals with moderate-to-severe asthma for at least a year, who experience frequent attacks despite current treatment, might be suitable candidates. As a Phase 2 trial, the research focuses on assessing the treatment's effectiveness in an initial, smaller group, offering participants an opportunity to contribute to significant 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, but it mentions that participants should have been on a stable dose of their asthma medications for at least one month before starting the trial. 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 has shown that lunsekimig, the treatment under study for asthma, appears to be safe. One study found that a single dose of lunsekimig was well-tolerated by people with mild to moderate asthma, with most experiencing no serious side effects. Another study on the long-term use of lunsekimig also focused on safety, indicating that researchers are carefully monitoring for any risks.

Earlier tests confirmed that lunsekimig was safe and did not cause major issues. These results suggest that the treatment is generally well-tolerated. However, as with any new treatment, ongoing studies must continue to monitor for any possible side effects. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatment for asthma?

Researchers are excited about SAR443765 for asthma because it offers a fresh approach compared to typical options like inhaled corticosteroids and bronchodilators. Unlike these traditional treatments, SAR443765 involves a subcutaneous injection, potentially offering a new method of delivering asthma relief. The active ingredient, lunsekimig, may work differently by targeting specific pathways in the immune system, which could lead to better control of asthma symptoms. This innovative mechanism could provide an alternative for patients who do not respond well to current treatments.

What evidence suggests that SAR443765 might be an effective treatment for asthma?

Research has shown that lunsekimig, also known as SAR443765, may help treat asthma. One study found that a single dose was well tolerated and significantly reduced a type of immune response linked to asthma. This trial will test different doses and dosing intervals of lunsekimig to evaluate its effectiveness in improving lung function in people with mild-to-moderate asthma. These findings suggest that lunsekimig could help manage asthma symptoms by effectively targeting inflammation. ^{1 2 6 7 8}

Who Is on the Research Team?

Clinial Science & Operations

Principal Investigator

Sanofi

Are You a Good Fit for This Trial?

Adults aged 18-80 with moderate to severe asthma, using inhaled steroids and up to two other controllers for at least 3 months. Must have had an asthma attack in the past year despite treatment. Can't join if they've smoked or vaped recently, had a recent respiratory infection, been hospitalized for asthma within a month, or have serious health issues like heart failure.

Inclusion Criteria

I have been diagnosed with severe asthma for over a year.

I've been on a stable dose of moderate-to-high ICS and up to 2 other medications for at least 4 months.

I've had at least one asthma attack in the last year despite using a lot of my inhaler.

Exclusion Criteria

I had a respiratory infection in the last 4 weeks.

I do not have severe illnesses like heart failure or kidney disease that would stop me from joining the study.

I have a lung condition like COPD that affects my breathing.

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 according to established dosing intervals

48 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SAR443765

Trial Overview The study is testing SAR443765's effectiveness and safety as an add-on therapy compared to a placebo. Participants will be randomly assigned to receive either the test drug or placebo alongside their current asthma treatments.

How Is the Trial Designed?

Group I: Lunsekimig Dose1 interval 1 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 1

Group II: Lunsekimig Dose 2 interval 2 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 2

Group III: Lunsekimig Dose 2 interval 1 Experimental Treatment 1 Intervention

Participants will receive Dose 2 of lunsekimig (subcutaneous injection) according to established dosing interval 1

Group IV: Lunsekimig Dose 1 interval 2 Experimental Treatment 1 Intervention

Participants will receive Dose 1 of lunsekimig (subcutaneous injection) according to established dosing interval 2

Group V: Placebo Placebo Group 1 Intervention

Participants will receive placebo (subcutaneous injection) according to established dosing intervals corresponding to Dose 1 and Dose 2

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

In the LIBERTY ASTHMA QUEST trial, dupilumab significantly reduced severe asthma exacerbation rates by 32.2% to 34.6% and improved lung function (FEV1) in patients with moderate-to-severe asthma and comorbid perennial allergic rhinitis (PAR), demonstrating its efficacy in this population.

Dupilumab not only improved asthma control and quality of life related to rhinoconjunctivitis but also suppressed type 2 inflammatory biomarkers, indicating its dual action on IL-4 and IL-13 pathways, which are crucial in managing both asthma and allergic rhinitis.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis. Busse, WW., Maspero, JF., Lu, Y., et al.[2020]

In the phase 3 NAVIGATOR study involving patients aged 12-80 with severe asthma, tezepelumab significantly improved various lung function parameters, including pre-bronchodilator FEV1 and forced vital capacity (FVC), compared to placebo over 52 weeks.

Improvements in lung function were observed as early as 1-2 weeks and were particularly pronounced in patients with a shorter disease duration and specific baseline lung function characteristics, indicating tezepelumab's efficacy in managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. Menzies-Gow, A., Ambrose, CS., Colice, G., et al.[2023]

In the phase 2b PATHWAY study involving 550 adults with severe, uncontrolled asthma, tezepelumab significantly reduced asthma exacerbations by up to 71% and improved lung function and quality of life compared to placebo.

Tezepelumab treatment led to higher rates of patient-reported outcomes, with up to 82% of patients showing improved asthma control and quality of life, indicating its effectiveness in managing severe asthma symptoms.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. Corren, J., Garcia Gil, E., Griffiths, JM., et al.[2021]

Tezepelumab significantly reduced asthma exacerbations by 60% compared to placebo in a pooled analysis of 1,334 patients from two major trials, demonstrating its efficacy across various subgroups of severe, uncontrolled asthma.

The treatment not only lowered the rate of exacerbations but also decreased related hospitalizations and emergency visits, with a similar safety profile to placebo, indicating it is a safe and effective option for managing severe asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. Corren, J., Menzies-Gow, A., Chupp, G., et al.[2023]

In the phase 3 NAVIGATOR study involving 1059 patients with severe asthma, tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) by 58% to 68% compared to placebo over 52 weeks, particularly in patients with allergic asthma.

Tezepelumab also improved lung function (FEV1) and patient-reported outcomes while reducing type 2 inflammation biomarkers, demonstrating its efficacy in a broad range of patients with severe, uncontrolled asthma.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study. Corren, J., Ambrose, CS., Griffiths, JM., et al.[2023]

Citations

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

A first‐in‐human, single and multiple dose study of ... The efficacy, safety, and tolerability of add‐on therapy with lunsekimig in adults with moderate‐to‐severe asthma are currently being assessed ...

2. 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 ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39884759/

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

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 ... New phase 2 data for amlitelimab show efficacy in heterogeneous inflammatory asthma · Lunsekimig now targeting chronic rhinosinusitis and COPD in ...

5. mountsinai.org mountsinai.org/clinical-trials/study-of-lunsekimig-sar443765-compared-with-placebo-in-adults-with-high-risk-asthma

Study of Lunsekimig (SAR443765) Compared With ... 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. sanofistudies.com sanofistudies.com/cwout/CW-V9DEXS//us/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. Asthma is a condition ...

7. 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.

8. 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 ... A Single Dose of SAR443765 Was Safe and Well-Tolerated in Mild ...