Image

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma.

Recruiting
18 years and older
All
Phase 2

Powered by AI

Overview

This is a phase 2, open-label extension study to evaluate the long-term safety and efficacy of lunsekimig in adult participants with asthma who have previously completed the parent studies. After completion of the parent study, eligible participants will be offered the opportunity to participate in the long-term extension (LTE) study with lunsekimig.

The study duration will be up to 100 weeks with a treatment duration being up to 96 weeks.

Description

Enter Intervention Groups

Eligibility

Inclusion Criteria:

  1. Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
  2. Participants with stable background therapy with moderate or high-dose ICS in combination with the following controller medications, as maintained during the respective parent study in which they have participated:
    • For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines) with or without oral prednisone
    • For Study ACT18301: LABA with or without LTRA
  3. Participants who are able and willing to participate in the open-label extension

    study, and to comply with requested study visits and procedures

  4. Contraception for male and female participants

    For female participants:

    • must agree to use contraception/barrier
    • not pregnant or breast feeding
    • no eggs donation or cryopreserving eggs

For male participants:

  • No sperm donation or cryopreserving sperm 5. Capable of giving signed informed consent

Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply:

  1. Participant who developed a new medical condition or a change in status of an established medical condition or requires a new treatment or medication prior to enrollment that, per Investigator's medical judgement would adversely affect participation of the participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures
  2. Participant who was diagnosed with a new pulmonary disease which may impair lung function
  3. Current smoker or active vaping of any products and/or marijuana smoking
  4. Prescription drug or substance abuse, including alcohol, considered significant by the Investigator
  5. History of hypersensitivity or allergy to lunsekimig or to any of the excipients used in the presentation or in preparation for administration of lunsekimig, or other allergy that, in the opinion of the Investigator, contraindicates participation in the study
  6. Participants who are receiving prohibited concomitant medications
  7. Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant
  8. Concurrent participation in any other clinical study, including non-interventional studies
  9. Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized
  10. Participants are employees of the investigative site or other individuals directly involved in the conduct of the study, or immediate family members of such individuals.

Study details
    Asthma

NCT06609239

Sanofi

1 November 2025

Step 1 Get in touch with the nearest study center
We have submitted the contact information you provided to the research team at {{SITE_NAME}}. A copy of the message has been sent to your email for your records.
Would you like to be notified about other trials? Sign up for Patient Notification Services.
Sign up

Send a message

Enter your contact details to connect with study team

Investigator Avatar

Primary Contact

  Other languages supported:

First name*
Last name*
Email*
Phone number*
Other language

FAQs

Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

Do I get compensated for taking part in clinical trials?

Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

How safe are clinical trials?

Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
Add a private note
  • abc Select a piece of text.
  • Add notes visible only to you.
  • Send it to people through a passcode protected link.