Long-term evaluation of lunsekimig for chronic rhinosinusitis with nasal polyps
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
This study is testing how well lunsekimig works over a longer period for adults with chronic rhinosinusitis and nasal polyps who have already participated in a previous trial.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Enrollment | 64 (estimated) |
| Sex | All |
| Sponsor | Sanofi Industry-sponsored |
| Locations | 24 sites (La Jolla, California and 23 other locations) |
| Trial ID | NCT06914908 on ClinicalTrials.gov |
What this trial studies
This study is an extension of a previous clinical trial focusing on the long-term safety, tolerability, and efficacy of lunsekimig in adults with chronic rhinosinusitis with nasal polyps (CRSwNP). Participants who have previously completed a lunsekimig study will receive treatment for up to 52 weeks, followed by a 4-week follow-up period. The study aims to gather data on how well lunsekimig works over an extended timeframe in managing CRSwNP symptoms. Additionally, participants will continue using mometasone furoate nasal spray as part of their treatment regimen.
Who should consider this trial
Good fit: Ideal candidates are adults who have previously participated in a lunsekimig study and have inadequately controlled CRSwNP.
Not a fit: Patients who have had a hypersensitivity reaction to lunsekimig or are currently participating in other clinical studies may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide a long-term treatment option for patients suffering from chronic rhinosinusitis with nasal polyps.
How similar studies have performed: Other studies on lunsekimig have shown promise, but this specific long-term evaluation is novel.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
La Jolla, California and 23 other locations
- Modena Allergy + Asthma- Site Number : 8400005 — La Jolla, California, United States (Recruiting)
- Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003 — Roseville, California, United States (Recruiting)
- Treasure Valley Medical Research- Site Number : 8400002 — Boise, Idaho, United States (Active_not_recruiting)
- Essential Medical Research- Site Number : 8400020 — Tulsa, Oklahoma, United States (Recruiting)
- McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017 — Bellaire, Texas, United States (Recruiting)
- Pharmaceutical Research & Consulting- Site Number : 8400004 — Dallas, Texas, United States (Recruiting)
- ENT Associates of Texas - McKinne- Site Number : 8400014 — McKinney, Texas, United States (Recruiting)
- Alamo ENT Associates- Site Number : 8400001 — San Antonio, Texas, United States (Recruiting)
- Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008 — Norfolk, Virginia, United States (Recruiting)
- Investigational Site Number : 0320002 — Rosario, Santa Fe Province, Argentina (Active_not_recruiting)
- Investigational Site Number : 0320001 — Buenos Aires, Argentina (Active_not_recruiting)
- Investigational Site Number : 0320003 — Mendoza, Argentina (Active_not_recruiting)
- Investigational Site Number : 0560002 — Ghent, Belgium (Active_not_recruiting)
- Investigational Site Number : 0560001 — Leuven, Belgium (Active_not_recruiting)
- Investigational Site Number : 1000001 — Sofia, Bulgaria (Recruiting)
- Investigational Site Number : 6160004 — Poznan, Greater Poland Voivodeship, Poland (Recruiting)
- Investigational Site Number : 6160002 — Krakow, Lesser Poland Voivodeship, Poland (Recruiting)
- Investigational Site Number : 6160007 — Wroclaw, Lower Silesian Voivodeship, Poland (Recruiting)
- Investigational Site Number : 6160001 — Warsaw, Masovian Voivodeship, Poland (Recruiting)
- Investigational Site Number : 6160005 — Warsaw, Masovian Voivodeship, Poland (Recruiting)
- Investigational Site Number : 6160003 — Katowice, Silesian Voivodeship, Poland (Recruiting)
- Investigational Site Number : 8260004 — Gloucester, Gloucestershire, United Kingdom (Recruiting)
- Investigational Site Number : 8260003 — Manchester, United Kingdom (Active_not_recruiting)
- Investigational Site Number : 8260001 — Newcastle upon Tyne, United Kingdom (Active_not_recruiting)
Study contacts
- Study coordinator: Trial Transparency email recommended (Toll free for US & Canada)
- Email: Contact-US@sanofi.com
- Phone: 800-633-1610
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.