A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
- 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
- Acronym
- COLOSSUS
- Short title
- A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
- Official title
- 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
- Control arm
- Open label
- Registry reports results
- Listing at source
- Listed
- Recruitment status
- Not yet recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Completion date
- 2031-10-28
- First posted
- 2026-08-28
- Registry last updated
- 2026-08-28
- Primary completion date
- 2031-10-28
- Start date
- 2026-09-14
- Participants
- 1,508
- Participant count basis
- Estimated
- Planned participants
- 1,508
- Protocol amendments
- Data monitoring committee
- Registry sponsor category
- Industry
- Lead sponsor
- Sanofi
- Source registry
- ClinicalTrials.gov
- Registry ID
- NCT07793409
- ClinicalTrials.gov ID
- NCT07793409
- Registry record
- Open registry record
- Allocation
- Randomised
- Model
- Parallel groups
- Purpose
- Treatment
- Masking
- No masking
Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
Timeframe: 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)
Timeframe: From Week 12 to Week 36
Annualized rate of moderate-to-severe COPD exacerbations
Timeframe: Study baseline to Week 96
Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Timeframe: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in pre-BD FEV1
Timeframe: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in SGRQ-C total score
Timeframe: Parent study baseline to Weeks 48 and 96
The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
ICS withdrawal sub-study: Time to first moderate or severe AECOPD
Timeframe: From Week 12 to Week 96
AECOPD: acute exacerbation of chronic obstructive pulmonary disease
ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score
Timeframe: From Week 12 to Week 36
The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.
- Sex
- All
- Age groups
- Adults, Older adults
- Minimum age
- 40 Years
- Maximum age
- 80 Years
- Healthy volunteers
- No
-
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
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.
- 2026-525981-22
- U1111-1333-2485
Related records
Drugs (1)
Lead sponsors (1)
Conditions (2)
- Chronic obstructive pulmonary disease Primary condition
- COPD, severe early onset