Skip to main content
OpenTrials
Not yet recruiting

NCT Number: NCT07793409

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

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

Not yet recruiting

Trial opening soon.

Get Notified

Key information

Conditions

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

Age range

40 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Lunsekimig

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

Other names: SAR443765

Primary outcomes

  1. 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

    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.

  2. 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

Secondary outcomes

  1. Annualized rate of moderate-to-severe COPD exacerbations

    Time frame: Study baseline to Week 96

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

    Time frame: Parent study baseline to Weeks 48 and 96

  3. Change from parent study baseline in pre-BD FEV1

    Time frame: Parent study baseline to Weeks 48 and 96

  4. Change from parent study baseline in SGRQ-C total score

    Time frame: Parent study baseline to Weeks 48 and 96

    The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.

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

    Time frame: From Week 12 to Week 96

    AECOPD: acute exacerbation of chronic obstructive pulmonary disease

  6. ICS withdrawal sub-study: Change from Week 12 to Week 36 in SGRQ-C total score

    Time frame: From Week 12 to Week 36

    The St. George's Respiratory Questionnaire (SGRQ) is a patient reported outcome measure designed to measure and quantify health status in adult patients with chronic airflow limitation. The SGRQ-C is a shorter (40 items) version derived from the original version using COPD data only. A global score ranges from 0 to 100 with lower scores indicating better quality-of-life.

Study contacts

Contact information is provided by the study sponsor or research team.

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

CONTACT

[email protected]

800-633-1610 ext. option 6

Sponsors and collaborators

Lead sponsor

Sanofi

Industry

Registry information

Official study 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

Acronym: COLOSSUS

Important dates

Study start
2026
Primary completion
2031
Study completion
2031
First posted
Aug 28, 2026
Registry last updated
Aug 28, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.