NCT07793409Enrolling by invitationPhase 3
A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
An Extension Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig, Including Inhaled Corticosteroid Withdrawal, in Adults With Chronic Obstructive Pulmonary Disease (COPD) Who Completed Studies EFC18243 or EFC18244
Source: ClinicalTrials.gov · Last updated 21 Oct 2026
Brief summary (registry, in English)
This is an open-label, Phase 3, long-term safety extension study including participants of previous lunsekimig clinical trials with inadequately controlled chronic obstructive pulmonary disease (COPD ) characterized by an eosinophilic phenotype. The purpose of the LTS 18211 study is to characterize the long-term safety and efficacy of lunsekimig in adults with COPD who completed studies EFC18243 or EFC18244 in the main study, and to assess the impact of inhaled corticosteroids (ICS ) withdrawal in the ICS withdrawal sub-study. The study duration will be up to 100 weeks, including the following components: * Baseline Visit (Visit 1 / Week 0) will coincide with the End-of-Intervention visit from the parent study (EFC18243 or EFC18244) if possible * Treatment duration of up to 96 weeks * Safety follow-up period of approximately 4 weeks * The number of visits will be 26
- Status (registry)
- Enrolling by invitation
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 1508 (estimated)
- First submitted
- 25 Aug 2026
- Start date
- 16 Sept 2026
- Primary completion date
- 23 Jul 2031
- Lead sponsor
- Sanofi
- Diseases
- COPD
- NCT number
- NCT07793409
- EudraCT number
- 2026-525981-22
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 1508
- From 16 Sept 2026 to the primary completion date, 23 Jul 2031
- 8 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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
- 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.
Other illness
- 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
Other
- The exclusion criteria are identical for LTS18211 and ICS withdrawal sub-study:
Who the study is looking for
- 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
Age in the registry: 40 years to 80 years · Sex: All · Does not accept healthy volunteers
Sites (8)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Guelph | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Saint-Charles-Borromée | Canada | Unknown status |
| - Coordinator of this site? Confirm its status | Chertsey | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Rotherham | United Kingdom | Unknown status |
| - Coordinator of this site? Confirm its status | Boynton Beach | United States | Unknown status |
| Deluxe Health Center- Site Number : 8403010 Coordinator of this site? Confirm its status | Miami Lakes | United States | Unknown status |
| - Coordinator of this site? Confirm its status | Newport Beach | United States | Unknown status |
| Clinical Research Trials of Florida- Site Number : 8403011 Coordinator of this site? Confirm its status | Tampa | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.