Status:
RECRUITING
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
Lead Sponsor:
Sanofi
Conditions:
Chronic Rhinosinusitis With Nasal Polyps
Eligibility:
All Genders
Phase:
PHASE2
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 previo...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
May 12 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
January 29 2031
Estimated Enrollment :
64 Patients enrolled
Trial Details
Trial ID
NCT06914908
Start Date
May 12 2025
End Date
January 29 2031
Last Update
January 6 2026
Active Locations (15)
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1
Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, United States, 92037
2
Treasure Valley Medical Research- Site Number : 8400002
Boise, Idaho, United States, 83706
3
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, United States, 74137
4
ENT Associates of Texas - McKinne- Site Number : 8400014
McKinney, Texas, United States, 75070