Age: 18+
Sex: Any
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Phase 2
Recruiting
Sponsor: Sanofi
Must be taking: ICS therapy
Disqualifiers: COPD, Smoking, Tuberculosis, others
Prior Safety Data
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.
12345Eligibility 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.
+1 more
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.
+4 more
Trial 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
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Allergy & Asthma Associates of Santa Clara Valley Site Number : 8400038San Jose, CA
Beautiful Minds Clinical Research Center Site Number : 8400049Cutler Bay, FL
Appalachian Clinical Research Site Number : 8400050Adairsville, GA
Javara Inc/Mankato Clinic, Site Number : 8400051Mankato, MN
More Trial Locations
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Who Is Running the Clinical Trial?
SanofiLead Sponsor
References
Efficacy of dupilumab on clinical outcomes in patients with asthma and perennial allergic rhinitis. [2020]Label="BACKGROUND">Comorbid perennial allergic rhinitis (PAR) or year-round aeroallergen sensitivity substantially contributes to disease burden in patients with asthma. Dupilumab blocks the shared receptor for interleukin (IL) 4 and IL-13, key drivers of type 2 inflammation that play important roles in asthma and PAR. In the LIBERTY ASTHMA QUEST trial (NCT02414854), dupilumab reduced severe asthma exacerbations and improved forced expiratory volume in 1 second (FEV1) in patients with uncontrolled, moderate-to-severe asthma, with greater efficacy observed in patients with elevated type 2 inflammatory biomarkers at baseline (blood eosinophils and fractional exhaled nitric oxide).
Tezepelumab improves patient-reported outcomes in patients with severe, uncontrolled asthma in PATHWAY. [2021]Patients with severe, uncontrolled asthma experience frequent exacerbations and hospitalization, leading to poor health-related quality of life. In the phase 2b PATHWAY study (NCT02054130), tezepelumab reduced exacerbations by up to 71% and improved lung function, asthma control, and health-related quality of life vs placebo.
Efficacy of Tezepelumab in Severe, Uncontrolled Asthma: Pooled Analysis of the PATHWAY and NAVIGATOR Clinical Trials. [2023]Rationale: Tezepelumab reduced exacerbations in patients with severe, uncontrolled asthma across a range of baseline blood eosinophil counts and fractional exhaled nitric oxide levels, and irrespective of allergy status, in the phase 2b PATHWAY (Study to Evaluate the Efficacy and Safety of MEDI9929 [AMG 157] in Adult Subjects With Inadequately Controlled, Severe Asthma; NCT02054130) and phase 3 NAVIGATOR (Study to Evaluate Tezepelumab in Adults & Adolescents With Severe Uncontrolled Asthma; NCT03347279) trials. Objectives: To examine the efficacy and safety of tezepelumab in additional clinically relevant subgroups using pooled data from PATHWAY and NAVIGATOR. Methods: PATHWAY and NAVIGATOR were randomized, double-blind, placebo-controlled trials with similar designs. This pooled analysis included patients with severe, uncontrolled asthma (PATHWAY, 18-75 years old; NAVIGATOR, 12-80 years old) who received tezepelumab 210 mg or placebo subcutaneously every 4 weeks for 52 weeks. The annualized asthma exacerbation rate over 52 weeks and secondary outcomes were calculated in the overall population and in subgroups defined by inflammatory biomarker levels or clinical characteristics. Measurements and Main Results: Overall, 1,334 patients were included (tezepelumab, n = 665; placebo, n = 669). Tezepelumab reduced the annualized asthma exacerbation rate versus placebo by 60% (rate ratio, 0.40 [95% confidence interval, 0.34-0.48]) in the overall population, and clinically meaningful reductions in exacerbations were observed in tezepelumab-treated patients with type 2-high and type 2-low disease by multiple definitions. Tezepelumab reduced exacerbation-related hospitalization or emergency department visits and improved secondary outcomes compared with placebo overall and across subgroups. The incidence of adverse events was similar between treatment groups. Conclusions: Tezepelumab resulted in clinically meaningful reductions in exacerbations and improvements in other outcomes in patients with severe, uncontrolled asthma, across clinically relevant subgroups. Clinical trials registered with www.clinicaltrials.gov (NCT02054130 [PATHWAY], NCT03347279 [NAVIGATOR]).
Efficacy of tezepelumab in patients with evidence of severe allergic asthma: Results from the phase 3 NAVIGATOR study. [2023]Allergic asthma is the most common phenotype among patients with severe asthma. In the phase 3 NAVIGATOR study (NCT03347279), tezepelumab significantly reduced the annualized asthma exacerbation rate (AAER) versus placebo in patients with severe, uncontrolled asthma. This exploratory analysis evaluated the efficacy of tezepelumab in NAVIGATOR participants with evidence of severe allergic asthma.
Effect of Tezepelumab on Lung Function in Patients With Severe, Uncontrolled Asthma in the Phase 3 NAVIGATOR Study. [2023]Label="INTRODUCTION">Severe asthma is associated with airway inflammation and airway obstruction. In the phase 3 NAVIGATOR study, tezepelumab treatment significantly improved pre-bronchodilator forced expiratory volume in 1 s (FEV1) compared with placebo in patients with severe, uncontrolled asthma. This analysis assessed the effect of tezepelumab versus placebo on additional lung function parameters in patients from NAVIGATOR.