Chronic Obstructive Pulmonary DiseasePhase 3COLOSSUSNCT07793409
A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
A Phase 3 study testing Lunsekimig in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 8 sites in 3 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Lunsekimig
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,508 participants
- Where
- 8 sitesin 3 countries
- Study dates
- 16 Sep 2026to 23 Jul 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Show all 11Show fewer
- 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
Who cannot join
- 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.
Trial locations and contacts
8 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
8 sites in 3 countries
United States4 sites
Helix Biomedics- Site Number : 8403065
Boynton Beach, Florida, 33435
Deluxe Health Center- Site Number : 8403010
Miami Lakes, Florida, 33014
Newport Native MD- Site Number : 8403003
Newport Beach, California, 92663
Clinical Research Trials of Florida- Site Number : 8403011
Tampa, Florida, 33607
Canada2 sites
Investigational Site Number : 1243004
Guelph, Ontario, N1h 6j2
Investigational Site Number : 1244050
Saint-Charles-Borromée, Quebec, J6E 2B4
United Kingdom2 sites
Investigational Site Number : 8264013
Chertsey, Surrey, KT16 0PZ
Investigational Site Number : 8264017
Rotherham, S61 1AH
About this study
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
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.
Read more
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
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Lunsekimig
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
LunsekimigDrug
Also called SAR443765
- Pharmaceutical form: Solution for injection in prefilled syringe
- Route of administration: Subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| Lunsekimig core study | Experimental | Subcutaneous (SC) administration of lunsekimig for up to 96 weeks, with the same inhaled controller medication as in the parent study (LABA + LAMA + ICS or LABA + LAMA) Receives: Drug: Lunsekimig |
| Lunsekimig sub-study with ICS maintenance | Experimental | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to maintain the same inhaled regimen Receives: Drug: Lunsekimig |
| Lunsekimig sub-study with ICS withdrawal | Experimental | ICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to withdraw ICS Receives: Drug: Lunsekimig |
What is being measured
The primary outcome is the main question the study is designed to answer.
Exposure-adjusted incidence rate of treatment-emergent adverse events (TEAE), including adverse events of special interest (AESI ) and serious adverse events (SAE)
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.
Measured: Study baseline to Week 100
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)
Measured: From Week 12 to Week 36
Secondary outcomes (6)
Annualized rate of moderate-to-severe COPD exacerbations
Measured: Study baseline to Week 96
Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Measured: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in pre-BD FEV1
Measured: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in SGRQ-C total score
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.
Measured: Parent study baseline to Weeks 48 and 96
ICS withdrawal sub-study: Time to first moderate or severe AECOPD
AECOPD: acute exacerbation of chronic obstructive pulmonary disease
Measured: From Week 12 to Week 96
ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score
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.
Measured: From Week 12 to Week 36
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Aug 2026
- Study start16 Sep 2026
- Primary completion23 Jul 2031 (estimated)
- Study completion23 Jul 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- More trials run by SanofiThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,508 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sanofi
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07793409
- Sponsor's protocol ID
- LTS18211
- Other IDs
- 2026-525981-22, U1111-1333-2485
- Acronym
- COLOSSUS
- Status last verified
- Oct 2026
- First submitted
- 25 Aug 2026
- Last updated
- 21 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
Study at a glance
From the registry record, last updated by the sponsor on 21 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07793409
- Acronym / sponsor ID
- COLOSSUS / LTS18211
- Conditions
- Chronic Obstructive Pulmonary Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Enrolling by invitation
- Enrolment
- 1,508 participants (estimated)
- Lead sponsor
- SanofiIndustry (pharma, biotech, devices)
- Study start
- 16 Sep 2026 (actual)
- Primary completion
- 23 Jul 2031 (estimated)
- Study completion
- 23 Jul 2031 (estimated)
- First posted
- 28 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Lunsekimig core study | Experimental | Drug: LunsekimigSubcutaneous (SC) administration of lunsekimig for up to 96 weeks, with the same inhaled controller medication as in the parent study (LABA + LAMA + ICS or LABA + LAMA) |
| Lunsekimig sub-study with ICS maintenance | Experimental | Drug: LunsekimigICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to maintain the same inhaled regimen |
| Lunsekimig sub-study with ICS withdrawal | Experimental | Drug: LunsekimigICS withdrawal sub-study: SC administration of lunsekimig for up to 96 weeks, with the inhaled controller medication LABA + LAMA + ICS in the run-in period followed by randomization to withdraw ICS |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- 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:
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| LunsekimigAlso: SAR443765* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection | Drug | Lunsekimig core study, Lunsekimig sub-study with ICS maintenance, Lunsekimig sub-study with ICS withdrawal |
Primary outcome
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
6 secondary outcomes
Annualized rate of moderate-to-severe COPD exacerbations
Time frame: Study baseline to Week 96
Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)
Time frame: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in pre-BD FEV1
Time frame: Parent study baseline to Weeks 48 and 96
Change from parent study baseline in SGRQ-C total score
Time frame: Parent study baseline to Weeks 48 and 96
ICS withdrawal sub-study: Time to first moderate or severe AECOPD
Time frame: From Week 12 to Week 96
ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score
Time frame: From Week 12 to Week 36
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Oct 2026.
- LTS18211 Plain Language Results SummaryLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Qualified researchers may request access to patient level data and related study documents including the clinical study report, study protocol with any amendments, blank case report form, statistical analysis plan, and dataset specifications. Patient level data will be anonymized and study documents will be redacted to protect the privacy of trial participants. Further details on Sanofi's data sharing criteria, eligible studies, and process for requesting access can be found at: https://vivli.org
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
The record lists no contact. Use the official record to reach the sponsor.
8 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Lunsekimig in people with Chronic Obstructive Pulmonary Disease, run by Sanofi at 8 sites in 3 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: enrolling by invitation, as of the sponsor's last update on 21 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in United States, Canada, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Oct 2026.