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Clinical Trials in Canada / NCT07793409
Recruiting Phase 3

A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)

NCT07793409 · tracked via the Priya Life Science Canada tracker
Sponsor
Sanofi
Phase
Phase 3
Started
2026-09-16
Last updated
2026-09-21

Condition(s) studied

Chronic Obstructive Pulmonary Disease

Investigational drug(s) / intervention(s)

Lunsekimig →

Lunsekimig: * Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection

Study summary

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

Eligibility

Sex
ALL
Min age
40 Years
Max age
80 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

  • Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE) — Study baseline to Week 100
    Exposure-adjusted incidence rate is defined as the number of patients with at least one specific treatment emergent adverse event in question per 100 patients taking the treatment for 1 year.
  • ICS withdrawal sub-study: Change from Week 12 (end of run-in period) to Week 36 in pre-Bronchodilator Forced Expiratory Volume in 1 second (pre-BD FEV1) — From Week 12 to Week 36

Trial sites (3)

FacilityCityRegionStatus
Newport Native MD- Site Number : 8403003 Newport Beach California Recruiting
Helix Biomedics- Site Number : 8403065 Boynton Beach Florida Recruiting
Investigational Site Number : 8264017 Rotherham United Kingdom Recruiting

More Sanofi trials in Canada

Long-term Safety and Efficacy Evaluation of Lunsekimig (SAR443765) in Adult Participants With Asthma Enrolling by invitation
A 52-week Study of Rilzabrutinib Efficacy and Safety Compared to Placebo in Adults Diagnosed With IgG4-related Disease Recruiting
A Study Assessing Esophageal Function and Remodeling With Dupilumab Compared With Placebo for 24 Weeks Followed by 104 Weeks Open Label in Adult Participants With EoE (REMOdeling With Dupilumab in Eosinophilic Esophagitis Long-term Trial) Active, not recruiting
Efanesoctocog Alfa Prophylaxis in Patients With Hemophilia A With Synovial Hypertrophy Recruiting
A Study to Evaluate the Effect of Venglustat Tablets on Left Ventricular Mass Index in Male and Female Adult Participants With Fabry Disease Active, not recruiting

Other trials for the same condition

Oral Sildenafil for Exercise Capacity, Dyspnea and Cardiopulmonary Function in COPD Recruiting
A Study to Investigate Airway Inflammation With Dupilumab Subcutaneously in Participants Aged ≥40 to ≤85 Years With Chronic Obstructive Pulmonary Disease. Recruiting
Efficacy, Safety, and Tolerability Study of Lunsekimig Compared With Placebo in Adult Participants With Inadequately Controlled Chronic Obstructive Pulmonary Disease (COPD) Characterized by an Eosinophilic Phenotype Recruiting
Micro-doses of Physical Activity for COPD Recruiting
Evaluation of Nurse-led Integrated Care of Complex Patients Facilitated By Telemonitoring: The SMaRT Study Active, not recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07793409 on ClinicalTrials.gov ↗ ← All trials in Canada