A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age40-80
SponsorSanofi
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Participants who completed the treatment period of EFC18243 or EFC18244 studies, including EOI visit
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Lunsekimig
Drug* Pharmaceutical form: Solution for injection in prefilled syringe * Route of administration: Subcutaneous injection
Treatment groups
1,508 Participants
are divided into 3 treatment groupsGroup A: Lunsekimig core studyExperimental treatment 1 intervention
Group B: Lunsekimig sub-study with ICS maintenanceExperimental treatment 1 intervention
Group C: Lunsekimig sub-study with ICS withdrawalExperimental treatment 1 intervention
Trial outcomes
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)
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.
Time frame
Study baseline to Week 1002
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 36Secondary outcomes
1
Annualized rate of moderate-to-severe COPD exacerbations
Time frame
Study baseline to Week 962
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 963
Change from parent study baseline in pre-BD FEV1
Time frame
Parent study baseline to Weeks 48 and 964
Change from parent study baseline in SGRQ-C total score
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.
Time frame
Parent study baseline to Weeks 48 and 96 Source ClinicalTrials.gov