Recruiting
Phase 3

Lunsekimig

Sponsor:

Sanofi

Code:

NCT07793409

Conditions

Chronic Obstructive Pulmonary Disease

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

Interventions

Lunsekimig

Study Details

Brief 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

Conditions

Chronic Obstructive Pulmonary Disease

Study ID

NCT07793409

Start date

Sep 16, 2026

Status verified date

Sep, 2026

Completion date

Jul 23, 2031

Anticipated

Primary completion date

Jul 23, 2031

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 40 - 70+

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

1508 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Lunsekimig core study

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)

experimental: Lunsekimig sub-study with ICS maintenance

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

experimental: Lunsekimig sub-study with ICS withdrawal

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

Interventions

Lunsekimig

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

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 ]
  • 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 ]

Central Contacts and Locations

Central contacts

Trial Transparency email recommended (Toll free for US & Canada)

800-633-1610Contact-US@sanofi.com

Locations

Newport Native MD- Site Number : 8403003

Recruiting

Newport Beach, California, United States, 92663

Helix Biomedics- Site Number : 8403065

Recruiting

Boynton Beach, Florida, United States, 33435

More Information

Sponsor

Sanofi

Last update posted

Sep 21, 2026

Last verified

Sep, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-24. This information was provided to ClinicalTrials.gov by Sanofi on 2026-09-21. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.