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

Sanofi

Status and phase: Enrolling; Phase 2

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Treatments: Drug: Mometasone furoate nasal spray (MFNS); Drug: lunsekimig

Study type: Interventional

Funder types: Industry

Identifiers

NCT06914908

2024-515912-27 (Registry Identifier)

LTS18300

Details and patient eligibility

About

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.

Enrollment: 64 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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64 participants in 1 patient group

Lunsekimig

Experimental group

Description:

Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.

Treatment:

Drug: lunsekimig

Drug: Mometasone furoate nasal spray (MFNS)