Trial studying safety and effects for Chronic Obstructive Pulmonary Disease
Official title A Study to Evaluate the Long-term Safety and Efficacy of Lunsekimig in Adult Participants With Chronic Obstructive Pulmonary Disease (COPD)
ClinicalTrials.gov ID: NCT07793409
What this study is testing
What is Lunsekimig?
Lunsekimig is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for chronic obstructive pulmonary disease.
Also referred to as SAR443765.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 40 to 80
You may be able to join if
- 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...
- 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...
You likely can't join if
- 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...
- 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...
- 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...
See the full eligibility 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
- 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...
- 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...
- 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...
The study team makes the final eligibility decision.
Where it's taking place
- Newport Beach, California, United States
- Boynton Beach, Florida, United States
- Rotherham, United Kingdom
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 40 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Newport Beach, California, United States; Boynton Beach, Florida, United States; Rotherham, United Kingdom. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.