By InvitationPhase 2

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

United States, Argentina, Brazil900 participantsStarted 2024-09-30

Plain-language summary

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 148 weeks with a treatment duration being up to 144 weeks.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * Participants who completed the 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 * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: For female participants: * incapable of becoming pregnant, or * not pregnant or breast feeding * no eggs donation or cryopreserving eggs For male participants: \-- No sperm donation or cryopreserving sperm \- Capable of giving signed informed consent Exclusion Criteria: Participants are excluded from the study if any of the following criteria apply: * 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 par…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This trial is specifically measuring safety events over the long term for a drug called lunsekimig — since it's still in Phase 2, how much do we already know about its safety profile, and what would that mean for me compared to approved asthma treatments I could try instead?
2The trial is 'enrolling by invitation only' — can you tell me whether I would even be considered for an invitation, and what criteria are being used to select participants?
3Since the main thing being tracked is the rate of serious adverse events and special-interest side effects, what types of side effects are researchers specifically watching for with lunsekimig, and how do those compare to risks from my current asthma medications?
4Because this is a long-term safety study in Phase 2, how long would I likely need to stay in the trial, and what would my ongoing asthma care look like during that time if my symptoms weren't well controlled?
5Given that this is still an early-phase study focused primarily on safety rather than proven benefit, would it make more sense for me to try an established biologic or controller medication first before considering an experimental option like this?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Exposure-adjusted incidence rate of treatment-emergent adverse event (TEAE), including adverse events of special interest (AESI), and serious adverse event (SAE)

Timeframe: From study baseline to week 148

Trial details

NCT IDNCT06609239

SponsorSanofi

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2031-01-20

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