Nasal Polyps Clinical Trials

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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: Enrolling_by_invitation
Location: See all (24) 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
Modena Allergy + Asthma- Site Number : 8400005
La Jolla
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville
Idaho
Treasure Valley Medical Research- Site Number : 8400002
Boise
Oklahoma
Essential Medical Research- Site Number : 8400020
Tulsa
Texas
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire
Pharmaceutical Research & Consulting- Site Number : 8400004
Dallas
ENT Associates of Texas - McKinne- Site Number : 8400014
Mckinney
Alamo ENT Associates- Site Number : 8400001
San Antonio
Virginia
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk
Other Locations
Argentina
Investigational Site Number : 0320001
Buenos Aires
Investigational Site Number : 0320003
Mendoza
Investigational Site Number : 0320002
Rosario
Belgium
Investigational Site Number : 0560002
Ghent
Investigational Site Number : 0560001
Leuven
Bulgaria
Investigational Site Number : 1000001
Sofia
Poland
Investigational Site Number : 6160003
Katowice
Investigational Site Number : 6160002
Krakow
Investigational Site Number : 6160004
Poznan
Investigational Site Number : 6160001
Warsaw
Investigational Site Number : 6160005
Warsaw
Investigational Site Number : 6160007
Wroclaw
United Kingdom
Investigational Site Number : 8260004
Gloucester
Investigational Site Number : 8260003
Manchester
Investigational Site Number : 8260001
Newcastle Upon Tyne
Time Frame
Start Date: 2025-05-12
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