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

Status: Recruiting
Location: See all (8) locations...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Healthy Volunteers: f
View:

• 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.

Locations
United States
California
Allergy & Rheumatology- Site Number : 8400005
RECRUITING
La Jolla
Idaho
Treasure Valley Medical Research- Site Number : 8400002
RECRUITING
Boise
Texas
ENT Associates of Texas - McKinne- Site Number : 8400014
RECRUITING
Mckinney
Alamo ENT Associates- Site Number : 8400001
RECRUITING
San Antonio
Other Locations
Argentina
Investigational Site Number : 0320001
RECRUITING
Buenos Aires
Investigational Site Number : 0320003
RECRUITING
Mendoza
Investigational Site Number : 0320002
RECRUITING
Rosario
United Kingdom
Investigational Site Number : 8260001
RECRUITING
Newcastle Upon Tyne
Contact Information
Primary
Trial Transparency email recommended (Toll free for US & Canada)
Contact-US@sanofi.com
800-633-1610
Time Frame
Start Date: 2025-05-12
Estimated Completion Date: 2031-01-29
Participants
Target number of participants: 64
Treatments
Experimental: Lunsekimig
Participant will receive lunsekimig subcutaneous (SC) every 4 weeks and intranasal mometasone furoate nasal spray (MFNS) daily for 52 weeks.
Sponsors
Leads: Sanofi

This content was sourced from clinicaltrials.gov