← Back to Search

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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from baseline to week 48

Awards & highlights

AIRCULES Trial Summary

This trial tests a new drug to help adults 18-80 with asthma. It'll check its safety, efficacy and how it's tolerated.

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.Check my eligibility

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.See study design

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.

AIRCULES Trial Eligibility Criteria

Inclusion Criteria

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

Select...

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

Select...

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

AIRCULES Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Annualized rate of asthma exacerbation events

Secondary outcome measures

Annualized rate of loss of asthma control events (LOAC) events

Annualized rate of severe asthma exacerbations requiring hospitalization or emergency room or urgent care visit

Anti-drug antibodies (ADA) against SAR443765

+14 more

AIRCULES Trial Design

5Treatment groups

Experimental Treatment

Placebo Group

Group I: SAR443765 Dose1 interval 1Experimental Treatment1 Intervention

Participants will receive Dose 1 of SAR443765 (subcutaneous injection) according to established dosing interval 1

Group II: SAR443765 Dose 2 interval 2Experimental Treatment1 Intervention

Participants will receive Dose 2 of SAR443765 (subcutaneous injection) according to established dosing interval 2

Group III: SAR443765 Dose 2 interval 1Experimental Treatment1 Intervention

Participants will receive Dose 2 of SAR443765 (subcutaneous injection) according to established dosing interval 1

Group IV: SAR443765 Dose 1 interval 2Experimental Treatment1 Intervention

Participants will receive Dose 1 of SAR443765 (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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

SAR443765

2022

Completed Phase 1

~40

0 / 2Eligibility criteria met

Find a Location

Who is running the clinical trial?

SanofiLead Sponsor

2,164 Previous Clinical Trials

3,514,350 Total Patients Enrolled

46 Trials studying Asthma

26,708 Patients Enrolled for Asthma

Clinial Science & OperationsStudy DirectorSanofi

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Do I meet the prerequisites to join this research project?

"Candidates of this study should suffer from asthma and be aged between 18-80 years old. Approximately 630 participants are needed in total."

Answered by AI

Are geriatric individuals being offered the opportunity to join this research?

"The requirements for participating in this research project are that the patient is between 18 to 80 years old. There are 137 trials specifically designed for those under 18 and 203 study opportunities available to those over 65."

Answered by AI

How many participants is this clinical trial accommodating?

"Affirmative. Clinicaltrials.gov holds evidence that this medical trial, which was first listed on October 16th 2023, is currently recruiting participants. To achieve the desired sample size of 630 patients, recruitment is only taking place at one site."

Answered by AI

Are there any available slots in this clinical research program?

"According to the publicly available information, this clinical trial is actively accepting applicants. The study was first announced in October 16th of 2023 and has seen a recent update on the 20th of that same month."

Answered by AI

Has the FDA sanctioned SAR443765 Dose1 interval 1?

"Our collective evaluation at Power assigned SAR443765 Dose1 interval 1 a rating of 2 due to the Phase 2 trial status, which has provided some evidence for safety but not efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Dose Ranging Study of SAR443765 Compared With Placebo-control in Adult Participants With Moderate to Severe Asthma

2023. "Dose Ranging Study of SAR443765 Compared With Placebo-control in Adult Participants With Moderate to Severe Asthma". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT06102005.

All > Pediatric Asthma > Paid Studies Pittsburgh