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

NCT07793409 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: LTS182112026-525981-22U1111-1333-2485
• Study Type: interventional
• Target: 1,508
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (2)

• 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.

  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)

  From Week 12 to Week 36

Secondary Outcomes (6)

• Annualized rate of moderate-to-severe COPD exacerbations

  Study baseline to Week 96

• Change from parent study baseline in post-Bronchodilator Forced Expiratory Volume in 1 second (post-BD FEV1)

  Parent study baseline to Weeks 48 and 96

• Change from parent study baseline in pre-BD FEV1

  Parent study baseline to Weeks 48 and 96

• Change from parent study baseline in SGRQ-C total score

  Parent study baseline to Weeks 48 and 96

• ICS withdrawal sub-study: Time to first moderate or severe AECOPD

  From Week 12 to Week 96

Study Arms (3)

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)

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

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

Drug: Lunsekimig

Interventions

Lunsekimig DRUG

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

Also known as: SAR443765

Lunsekimig core study; Lunsekimig sub-study with ICS maintenance; Lunsekimig sub-study with ICS withdrawal

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Sanofi: lead

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

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

CONTACT

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

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: August 28, 2026
• Study Start (Estimated): September 14, 2026
• Primary Completion (Estimated): October 28, 2031
• Study Completion (Estimated): October 28, 2031
• Last Updated: August 28, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will share