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

Investigational Medication Study for Long-term Safety in Chronic Rhinosinusitis with Nasal Polyps

Recruiting
All
Phase 2
64 participants needed
1 Location

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
  • 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

Updated on 18 May 2025. Study ID: NCT06914908

This study investigates the long-term safety, tolerability, and efficacy of an investigational medication in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have completed a previous clinical study with the same medication. CRSwNP is a condition where growths called polyps form in the nasal passages and sinuses, leading to symptoms like congestion and loss of smell.

Participants in this study will continue to receive treatment with the investigational medication. They will also use a nasal spray called mometasone furoate, which is a common medication for managing nasal symptoms. The study involves regular check-ups to monitor the effects and any side effects of the treatment.

  • Who can participate: Adults who have completed a previous study with the investigational medication and are using mometasone furoate nasal spray can participate. They must be willing to attend study visits and follow study procedures.
  • Study details: Participants will take the investigational medication and continue using a nasal spray. They will have regular visits to check their health and the effects of the treatment.
  • Study timelines: The study will last 56 weeks per participant.

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