SAR443765 for Asthma

(AIRCULES Trial)

Recruiting at 274 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

685 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests an injectable medication called SC lunsekimig in adults aged 18 to 80 with moderate-to-severe asthma. The medication aims to reduce lung inflammation and open airways, helping patients breathe more easily.

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.

What data supports the effectiveness of the drug SAR443765 for asthma?

Research on similar drugs like tezepelumab shows that they can significantly reduce asthma attacks and improve lung function in patients with severe, uncontrolled asthma. This suggests that SAR443765 might also be effective in treating asthma. ^{1 2 3 4 5}

Research Team

Clinial Science & Operations

Principal Investigator

Sanofi

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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

Findings from Research

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 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]

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]

References

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

Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis. [2020]

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

Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. [2021]

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

Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. [2023]

4. England pubmed.ncbi.nlm.nih.gov

Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study. [2023]

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

Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. [2023]