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
Study on Long-Term Safety of Investigational Medication for Adults with Chronic Rhinosinusitis with Nasal Polyps
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). Chronic rhinosinusitis with nasal polyps is a condition where the nasal passages and sinuses become inflamed and swollen for a long time, leading to the formation of soft, painless growths called polyps. These polyps can block the nasal passages and make it difficult to breathe through the nose.
Participants in this study will continue to receive treatment with the investigational medication if they have already completed a previous related study. They will also use a nasal spray called mometasone furoate, which is a type of steroid that helps reduce inflammation in the nasal passages. The study will monitor the safety and tolerability of the treatment over an extended period.
- Who can participate: Adults who completed a previous study on the investigational medication for CRSwNP and use a nasal spray called mometasone furoate may participate. They must be willing to follow study procedures and attend all visits.
- Study details: Participants will continue receiving the investigational medication along with a nasal spray to manage their condition. The study will monitor the safety and effects of the treatment over a long period.
- Study timelines: The study will last 56 weeks.
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