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
A Single-arm Extension Study to Investigate the Long-term Safety, Tolerability, and Efficacy of Lunsekimig in Adult Participants With Inadequately Controlled Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Sanofi
64 participants
May 12, 2025
INTERVENTIONAL
Conditions
Summary
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
Inclusion Criteria3
- 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 Criteria5
- 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
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
Pharmaceutical form: solution for injection Route of administration: subcutaneous
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Locations(20)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06914908