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
Sanofi
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
- Age range
- Not specified
- Sex
- All
- Healthy volunteers
- No
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 presenta…
Interventions
- Druglunsekimig
Pharmaceutical form: solution for injection Route of administration: subcutaneous
- DrugMometasone furoate nasal spray (MFNS)
Pharmaceutical form: Intranasal spray Route of administration: intranasal
Locations (24)
- Modena Allergy + Asthma- Site Number : 8400005La Jolla, California
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003Roseville, California
- Treasure Valley Medical Research- Site Number : 8400002Boise, Idaho
- Essential Medical Research- Site Number : 8400020Tulsa, Oklahoma
- McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017Bellaire, Texas
- Pharmaceutical Research & Consulting- Site Number : 8400004Dallas, Texas