Early access
Sign in
Enrolling by invitationPhase 3

Long-term safety of lunsekimig in adults with chronic obstructive pulmonary disease

Follows adults with COPD who finished earlier lunsekimig studies and keep taking it.

Key facts

Who runs it
Sanofi
Where
Chertsey and Rotherham, United KingdomSee the 2 sitesAlso in 2 other countries, 6 sites
Trial code
Registry title
A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
Status
Enrolling by invitation
Phase
Phase 3
People taking part
1,508 people, planned
Started
16 Sept 2026
Expected to end
23 Jul 2031
Type of study
Interventional, 3 groups
Treatments tested
  • Lunsekimig
Record updated
21 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with COPD who finished the earlier lunsekimig studies EFC18243 or EFC18244. It checks long-term safety and effect of lunsekimig.

Age
40 to 80 years
Sex
All sexes
Disease stage
COPD that was not well controlled, with an eosinophilic type, who finished the earlier study.
Earlier treatment
Must have finished the treatment period of study EFC18243 or EFC18244. For the inhaled corticosteroid withdrawal part: on triple therapy (LABA+LAMA+ICS) and took lunsekimig as planned.

Main reasons for not taking part

  • A new medical condition or new treatment that would affect taking part
  • Drug or alcohol abuse the investigator considers significant
  • Allergy to lunsekimig or its ingredients
  • Taking prohibited medicines at the start
  • Side effect in the earlier study judged related to lunsekimig, with an unreasonable risk to continue

The registry criteria, word for word

Show all 12 criteriaShow less

Who can take part

  • 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

Who cannot take part

  • 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
  • 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
  • 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
  • The exclusion criteria are identical for LTS18211 and ICS withdrawal sub-study:

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 40 and 80 years old?

Where in United Kingdom

Also in 2 other countries, 6 sites

  • Chertsey, SurreyHospital not named in the registryEnrolling by invitation
  • RotherhamHospital not named in the registryEnrolling by invitation

About the trial

What the trial wants to find out

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 full original descriptionShow less

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

The 3 groups in the trial

  • Lunsekimig core studyTreatment being tested

    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)

    Treatment: Lunsekimig

  • Lunsekimig sub-study with ICS maintenanceTreatment being tested

    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

    Treatment: Lunsekimig

  • Lunsekimig sub-study with ICS withdrawalTreatment being tested

    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

    Treatment: Lunsekimig

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov.
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
Plain-language title
Long-term safety of lunsekimig in adults with chronic obstructive pulmonary diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 13 November 2026.
Fit questions
Built from NCT07793409, who can take part
Record updated
21 October 2026