Clinical trial NCT06914908: 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
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE2
Conditions: Chronic Rhinosinusitis With Nasal Polyps
Lead sponsor: Sanofi
Sponsor class: INDUSTRY
First posted: 2025-04-07
Enrollment: 64
Sex: ALL
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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 criteria: 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

Primary outcomes:
measure: Incidence of participants with treatment-emergent adverse events (TEAEs) including
timeFrame: From baseline to end of study (approximately 56 weeks)
Secondary outcomes:
measure: Change in SNOT-22 total score
timeFrame: From the parent study baseline to Week 52
measure: Change in rhinosinusitis visual analog scale (VAS)
timeFrame: From the parent study baseline to Week 52
measure: Change in University of Pennsylvania Smell Identification Test (UPSIT) score
timeFrame: From the parent study baseline to Week 52
measure: Serum lunsekimig concentrations
timeFrame: From baseline to end of study (approximately 56 weeks)
measure: Anti-drug antibodies (ADA) against lunsekimig
timeFrame: From baseline to end of study (approximately 56 weeks)
Other outcomes:
Locations:
city: La Jolla
country: United States
facility: Modena Allergy + Asthma- Site Number : 8400005
state: California
Study officials:
References: