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RecruitingPhase 3

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

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

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
40 Years to 80 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 100 weeks, 96 weeks

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "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"
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests the long-term safety of lunsekimig and how well it works in adults who completed study EFC18243 or EFC18244. These adults have COPD, a long-term lung disease, that is not well controlled and involves a type of white blood cell called eosinophils. A smaller part of the study tests the effects of stopping inhaled steroids.

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

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Completed treatment in study EFC18243 or EFC18244, including the end-of-treatment visit.
  • Follow the study's birth control rules during treatment and for 8 weeks after the last dose.
  • Women must not be pregnant or breastfeeding. Those who can become pregnant must agree to birth control rules and not donate or freeze eggs for having children.
  • Men must not donate or freeze sperm during treatment or for 8 weeks after the last dose.
  • For the steroid-stopping study only: take three COPD control medicines called LABA, LAMA, and ICS, which includes an inhaled steroid.
  • For the steroid-stopping study only: have taken lunsekimig as directed.
  • For the steroid-stopping study only: have had no more than one moderate COPD flare-up and no severe flare-ups during the earlier study.
  • For the steroid-stopping study only: have no COPD flare-ups during the lead-in period.

Who can't join

  • A new or changed health condition, or a new treatment, that the study doctor thinks could make participation unsafe or require stopping lunsekimig for good.
  • The study doctor thinks you may not be able to follow the study procedures.
  • Misuse of prescription drugs, alcohol, or other substances that the study doctor considers serious.
  • An allergy to lunsekimig or its ingredients, or another allergy that makes participation unsafe.
  • Taking medicines that are not allowed at the start of this study.
  • A health problem linked to lunsekimig during the earlier study that makes continued treatment too risky.

Simplified for readability. The official criteria below are what the study team uses.

Official 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.

Study sites (2)

CA

FL