ClinicaliQ Trial Snapshot
- Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma. — Recruiting • Phase II • Respiratory / COPD / Asthma • NCT06609239.
- Treatment being tested: Lunsekimig (SAR443765), a novel therapeutic agent, is being evaluated for long-term safety and efficacy in adults with asthma through an open-label extension study following completion of parent phase 2 trials.
- Patient eligibility overview: Adult participants with asthma who have successfully completed parent studies are eligible; this extension allows continued assessment in an established cohort with prior exposure to the investigational drug.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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.
Eligibility Snapshot
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- Participants who completed the 48-week treatment period of Study DRI16762 or ACT18301, including the EOT visit, as per protocol
- 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
- 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.