NCT07793409 · Sanofi
A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
(COLOSSUS)
What this study is about
This is an where both patients and doctors know the treatment given, 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.
View original scientific description
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.
Interventions
DRUG
Lunsekimig
* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection
Primary outcome measures
Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
Time frame: 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)
Time frame: From Week 12 to Week 36
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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.
Where
- Newport Beach, California
- Boynton Beach, Florida
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Sep 21, 2026 · Source of record for eligibility and locations