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

NCT07793409

Not Yet RecruitingPhase 3

Sponsor: Sanofi

Conditions: Chronic Obstructive Pulmonary Disease

Interventions: Lunsekimig

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

Eligibility overview

Sex: ALL

Age: 40 Years to 80 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

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.