Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study
Long-term Safety and Efficacy Evaluation of Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Completed a Previous Lunsekimig CRSwNP Clinical Study

NCT06914908

Enrolling By InvitationPhase 2

Sponsor: Sanofi

Conditions: Chronic Rhinosinusitis With Nasal Polyps

Interventions: Lunsekimig, Mometasone furoate nasal spray (MFNS)

Countries: United States, Argentina, Belgium, Bulgaria, Poland, United Kingdom

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 148 weeks per participant, including 144 weeks of treatment period and 4 weeks of follow-up.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility 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
* 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

The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
Locations (24)
  • La Jolla, California, United States
  • Roseville, California, United States
  • Boise, Idaho, United States
  • Tulsa, Oklahoma, United States
  • Bellaire, Texas, United States
  • Dallas, Texas, United States
  • McKinney, Texas, United States
  • San Antonio, Texas, United States
  • Norfolk, Virginia, United States
  • Rosario, Santa Fe Province, Argentina
  • Buenos Aires, Argentina
  • Mendoza, Argentina
  • Ghent, Belgium
  • Leuven, Belgium
  • Sofia, Bulgaria
  • Poznan, Greater Poland Voivodeship, Poland
  • Krakow, Lesser Poland Voivodeship, Poland
  • Wroclaw, Lower Silesian Voivodeship, Poland
  • Warsaw, Masovian Voivodeship, Poland
  • Warsaw, Masovian Voivodeship, Poland
  • Katowice, Silesian Voivodeship, Poland
  • Gloucester, Gloucestershire, United Kingdom
  • Manchester, United Kingdom
  • Newcastle upon Tyne, United Kingdom