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

Evaluation of Long-term Safety and Efficacy of an Investigational Medication in Adults with Asthma

Recruiting
18 years or above
All
Phase 2
900 participants needed
4 Locations

Study 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.

Study Details

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Eligibility Criteria

You may be eligible for this study if you meet the following criteria:

  • Conditions: Asthma
  • Age: 18 years or above
  • Gender: All

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.

This study investigates the long-term safety and efficacy of an investigational medication in adult participants with asthma. Participants who have completed previous studies with the investigational medication are eligible to join this extended study.

Participants will receive the investigational medication and continue their background therapy, which may include inhaled corticosteroids and other controller medications. The study will monitor the safety and effectiveness of the treatment over an extended period.

  • Who can participate: Adults who completed prior studies with the investigational medication and are on stable asthma therapy can participate. They must not have new medical conditions affecting participation and must not smoke or abuse substances.
  • Study details: Participants will continue using their asthma medications and receive the investigational medication. They must attend regular study visits and follow study procedures.
  • Study timelines: The study will last up to 100 weeks.
Updated on 27 Nov 2025. Study ID: NCT06609239

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