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Long-term safety and efficacy evaluation of lunsekimig (SAR443765) in adult participants with moderate-to-severe asthma.
EU CTIS ID: 2025-522896-27-00
What this study is testing
To evaluate long-term safety of lunsekimig in adult participants with asthma
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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: o For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone o 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 For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o No sperm donation or cryopreserving sperm
- Capable of giving signed informed consent
You likely can't join if
- 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 participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures.
- 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
- Participant who was diagnosed with a new pulmonary disease which may impair lung function.
- Current smoker or active vaping of any products and/or marijuana smoking.
- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- 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
See the full eligibility criteria
Who can join
- 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: o For Study DRI16762: At least 1 and no more than 2 additional controllers (eg, LABA, LAMA, LTRA, or methylxanthines), with or without oral prednisone o 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 For female participants: o incapable of becoming pregnant o not pregnant or breast feeding o no eggs donation or cryopreserving eggs For male participants: o No sperm donation or cryopreserving sperm
- Capable of giving signed informed consent
What rules you out
- 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 participant in this study or would require permanent lunsekimig discontinuation, or participants potentially at risk of noncompliance to study procedures.
- 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
- Participant who was diagnosed with a new pulmonary disease which may impair lung function.
- Current smoker or active vaping of any products and/or marijuana smoking.
- Prescription drug or substance abuse, including alcohol, considered significant by the Investigator.
- 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
- Participants who are receiving prohibited concomitant medications
- 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.
- Concurrent participation in any other clinical study, including non-interventional studies.
- Individuals accommodated in an institution because of regulatory or legal order; prisoners or participants who are legally institutionalized.
The study team makes the final eligibility decision.
Where it's taking place
- Israel
- Canada
- United Kingdom
- Taiwan
- Brazil
- Argentina
- Chile
- Japan
- China
- Mexico
- Korea, Republic of
- South Africa
- Turkey
- India
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Israel; Canada; United Kingdom; Taiwan; Brazil; Argentina and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.