Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Study
Investigation of Long-term Safety and Efficacy of an Investigational Medication in Adults with Chronic Rhinosinusitis with Nasal Polyps Who Completed a Previous Study
Study Overview
This is a single-arm extension study to investigate the long-term safety, tolerability, and efficacy of lunsekimig in adult participants with inadequately controlled CRSwNP who have completed a previous lunsekimig CRSwNP clinical study (also referred to as the parent study ACT18207).
The study duration will be up to approximately 56 weeks per participant, 52 weeks of treatment period, and 4 weeks of follow-up.
Eligibility Criteria
You may be eligible for this study if you meet the following criteria:
- Conditions: Chronic Rhinosinusitis With Nasal Polyps
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Gender: All
Inclusion Criteria:
- Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol.
- Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS).
- Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures.
Exclusion Criteria:
Participants are excluded from the study if any of the following criteria apply:
- Prior hypersensitivity reaction 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.
- Concurrent participation in any clinical study other than the parent study, including non-interventional studies.
- Participants who, during their participation in the parent study, developed an adverse event (AE) or a serious adverse event (SAE) deemed related to lunsekimig, which in the opinion of the Investigator could indicate that continued treatment with lunsekimig may present an unreasonable risk for the participant NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
This study investigates the long-term safety and effectiveness of an investigational medication in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Participants in this study have previously completed a related study and are continuing to evaluate the investigational medication's impact over an extended period.
Participants in this study will continue to receive the investigational medication while being monitored for safety, tolerability, and effectiveness. They will also use a nasal spray as part of their treatment. The study involves regular check-ups with healthcare professionals to ensure that participants are responding well to the treatment and to monitor any side effects.
- Who can participate: Adults who have completed the treatment and follow-up periods of a prior study on lunsekimig for CRSwNP and are currently using mometasone furoate nasal spray may participate. Participants must be willing to comply with study procedures and visits.
- Study details: Participants will continue to receive lunsekimig and attend regular visits for monitoring. They will also use mometasone furoate nasal spray as part of their treatment.
- Study timelines: The study will last up to approximately 56 weeks per participant.
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