Can a new injection help COPD patients cut steroid use?
NCT ID NCT07793409
First seen Aug 28, 2026 · Last updated Sep 04, 2026 · Updated 1 time
Summary
This Phase 3 extension study evaluates the long-term safety and efficacy of lunsekimig, an injectable drug, in adults with COPD who completed earlier lunsekimig trials. Participants receive lunsekimig for up to 96 weeks, and a sub-study tests whether they can safely withdraw from inhaled corticosteroids. The study tracks side effects, lung function, and COPD flare-ups to see if lunsekimig remains effective over time.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Lunsekimig (SAR443765), given as a subcutaneous injection
- What this could lead to
- If successful, this could support lunsekimig as a long-term treatment option for COPD, potentially allowing some patients to reduce or stop inhaled corticosteroids.
- What could go wrong
- This is an extension study, so it builds on earlier results and does not prove effectiveness on its own. Long-term use may still carry risks, and the ICS withdrawal part may not benefit all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,508 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Sep 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2031
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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40 to 80 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit * Contraception for male and female participants during the study intervention period and during 8 weeks following the last administration of study intervention. And: * Female participants: not pregnant or breastfeeding, and one of the following conditions applies: * Is not a women of childbearing potential (WOCBP), OR * Is a WOCBP and agrees to follow the contraceptive guidance. The WOCBP should also agree not to donate or cryopreserve eggs (ova, oocytes) for the purpose of reproduction. * Male participants: No sperm donation or cryopreserving sperm ICS-withdrawal sub-study only: * Participants receiving triple controller therapy (LABA+LAMA+ICS) * Participants who were compliant with lunsekimig * ≤ 1 moderate exacerbation and no severe exacerbation of COPD during the parent study * No exacerbation during the run-in period Exclusion Criteria: The exclusion criteria are identical for LTS18211 and ICS withdrawal sub-study: * 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 participant potentially at risk of noncompliance to study procedures * 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 at LTS18211 baseline * Participants who, during their participation in the parent study, developed an AE or an SAE deemed related to lunsekimig, and for whom continuation of treatment with lunsekimig may present an unreasonable risk The above information is not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The study's own enquiry address
This study publishes an address for enquiries. See it below .
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
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Contacts and locations
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Study contacts
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Contact
Email: •••••@•••••
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