What side effects are associated with this type of intervention?

Common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta agonists (LABAs), leukotriene receptor antagonists, and biologics. ICS can cause side effects such as oral thrush, hoarseness, and, in high doses, systemic effects like adrenal suppression. LABAs may lead to tremors, palpitations, and, rarely, cardiac arrhythmias. Leukotriene receptor antagonists, like montelukast, can cause headaches, gastrointestinal disturbances, and neuropsychiatric events. Biologics, such as monoclonal antibodies, can result in injection site reactions, headache, and an increased risk of infections. Specific side effects for SC lunsekimig are not detailed, but it is likely to share similar profiles with other biologics used in asthma treatment.

What prior FDA approvals exist?

The FDA has approved several advanced therapies for the treatment of moderate-to-severe asthma, particularly biologics targeting specific pathways involved in the inflammatory process. Notable examples include omalizumab (Xolair), which targets IgE, mepolizumab (Nucala) and reslizumab (Cinqair), which target IL-5, and dupilumab (Dupixent), which targets the IL-4 receptor alpha. These treatments are typically used as add-on therapies for patients who do not achieve adequate control with standard inhaled corticosteroids and long-acting beta agonists (LABAs).

What other types of research exist?

Promising novel alternatives for asthma treatment in 2024 include biologics such as dupilumab, which targets the IL-4 receptor alpha subunit, and tezepelumab, which targets thymic stromal lymphopoietin (TSLP). Both have shown efficacy in reducing asthma exacerbations and improving lung function in clinical trials. Additionally, new inhaled therapies like triple combination inhalers (ICS/LABA/LAMA) are also emerging as effective options for asthma management.

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SAR443765 for Asthma (AIRCULES Trial)

Phase 2

Recruiting

Research Sponsored by Sanofi

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

A physician-diagnosed moderate-to-severe asthma for ≥12 months based on GINA guidelines Steps 4 and 5

At least 1 asthma exacerbation in the past year, with at least one exacerbation occurring while on treatment with moderate to high doses of ICS therapy

Must not have

Chronic obstructive or other lung diseases (eg, COPD, idiopathic pulmonary fibrosis, etc) which may impair lung function, or another diagnosed pulmonary or systemic disease

Participants who experience a deterioration of asthma that results in emergency treatment or hospitalization, or treatment with systemic steroids within 1 month prior to the Screening

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 48

Summary

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.

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

While specific side effects of SAR443765 are not listed here, common risks may include injection site reactions, potential worsening of asthma symptoms, allergic reactions, and other immune-related effects.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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

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

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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I haven't had severe asthma attacks needing emergency care or steroids in the last month.

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I have been hospitalized for a serious infection in the last year while on chronic asthma steroids.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from baseline to week 48

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from baseline to week 48

This trial's timeline: 3 weeks for screening, Varies for treatment, and from baseline to week 48 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Secondary study objectives

Change from baseline in St. George's Respiratory Questionnaire (SGRQ) scores

Proportion of participants with ≥ 0.5-point reduction in ACQ-5 score

Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: Lunsekimig Dose1 interval 1Experimental Treatment1 Intervention

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

Group II: Lunsekimig Dose 2 interval 2Experimental Treatment1 Intervention

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

Group III: Lunsekimig Dose 2 interval 1Experimental Treatment1 Intervention

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

Group IV: Lunsekimig Dose 1 interval 2Experimental Treatment1 Intervention

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

Group V: PlaceboPlacebo Group1 Intervention

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

0 / 5Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for asthma include inhaled corticosteroids (ICS), long-acting beta agonists (LABA), and leukotriene receptor antagonists (LTRA). ICS reduce inflammation in the airways, decreasing the frequency and severity of asthma attacks. LABAs relax the muscles around the airways, making it easier to breathe and preventing symptoms. LTRAs block the action of leukotrienes, which are chemicals in the immune system that cause airway constriction and inflammation. These treatments are crucial for asthma patients as they help manage symptoms, improve lung function, and enhance overall quality of life by preventing exacerbations and maintaining better control of the condition.

Diagnosis and management of asthma in preschoolers: A Canadian Thoracic Society and Canadian Paediatric Society position paper.