ClinicaliQ Trial Snapshot
- A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD) — Recruiting • Phase III • Respiratory / COPD / Asthma • NCT07793409.
- Treatment being tested: Lunsekimig, a novel therapeutic agent being evaluated for long-term safety and efficacy in adults with eosinophilic COPD that remains inadequately controlled despite current management strategies.
- Patient eligibility: Adults with chronic obstructive pulmonary disease characterised by an eosinophilic phenotype who have previously participated in lunsekimig clinical trials and demonstrate inadequate disease control.
Use This Page For
- Quick orientation before opening the registry record.
- Checking recruitment status, phase and sponsor at a glance.
- Connecting this trial to nearby guidelines, Drug Science and education.
What This Trial Is Studying
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…
Eligibility Snapshot
- : * 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
Use the source registry for the full inclusion and exclusion criteria before discussing referral or enrolment.