RECRUITING

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

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Conditions

Chronic Rhinosinusitis With Nasal Polyps

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-05-12
Study Completion:2031-01-29
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:RECRUITING

Study ID

NCT06914908

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:Not specified
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:CHILD, ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Participants who have completed the treatment period and the follow up period in CRSwNP lunsekimig parent study, including EOS visit, as per protocol.
  2. * Participants receiving therapy with intranasal mometasone furoate nasal spray (MFNS).
  3. * Participants who are able and willing to participate in this extension study, and to comply with requested study visits and procedures.
  1. * 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.
  2. * Concurrent participation in any clinical study other than the parent study, including non-interventional studies.
  3. * 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

Contacts and Locations

Study Contact

Trial Transparency email recommended (Toll free for US & Canada)
CONTACT
800-633-1610
Contact-US@sanofi.com

Study Locations (Sites)

Modena Allergy + Asthma- Site Number : 8400005
La Jolla, California, 92037
United States

Collaborators and Investigators

Sponsor: Sanofi

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-05-12
Study Completion Date2031-01-29

Study Record Updates

Study Start Date2025-05-12
Study Completion Date2031-01-29

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Rhinosinusitis With Nasal Polyps