ACTIVE_NOT_RECRUITING

A Proof-of-concept Study of Lunsekimig Compared With Placebo in Adults With Chronic Rhinosinusitis With Nasal Polyps

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 parallel, Phase 2, 2-arm, multicenter, randomized, double-blind, placebo-controlled, proof-of-concept study for treatment of CRSwNP. The purpose of this study is to assess the efficacy, safety, and tolerability of add-on therapy with subcutaneous lunsekimig in adult participants (aged 18 to 70 years, inclusive) with CRSwNP who are inadequately controlled on intranasal corticosteroid treatment. Participants with and without co-morbid asthma will be included in the study, and lung function will be assessed in both groups. The study duration will be up to approximately 40 weeks per participant, including 4 weeks of screening run-in period, 24 weeks of intervention period, and 12 weeks of follow-up.

Official Title

A Randomized Phase 2, Double-blind, Placebo-controlled, Parallel-group, 2-arm Study to Assess the Efficacy, Safety, and Tolerability of Subcutaneous Lunsekimig in Adult Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

Quick Facts

Study Start:2024-07-17
Study Completion:2027-04-09
Study Type:Not specified
Phase:Not Applicable
Enrollment:Not specified
Status:ACTIVE_NOT_RECRUITING

Study ID

NCT06454240

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:18 Years to 70 Years
Sexes Eligible for Study:ALL
Accepts Healthy Volunteers:No
Standard Ages:ADULT, OLDER_ADULT
Inclusion CriteriaExclusion Criteria
  1. * Nasal congestion, blockage, or obstruction with moderate or severe symptom severity at screening (Score 2 or 3 on NC Score) and a weekly average severity score of at least 1 (range 0 to 3) at randomization (NC Score: 0=no symptoms, 1=mild, 2=moderate, and 3=severe).
  2. * At least 1 of the following 2 symptoms: (1) partial loss of smell (hyposmia) or total loss of smell (anosmia); (2) anterior and/or posterior rhinorrhea.
  1. * Patient who has received any therapies such as for example systemic corticosteroids, anti-IgE therapy, monoclonal antibody and some others in the specified timeframe(s) prior to the screening visit
  2. * Patients who have undergone any nasal/sinus surgery within 6 months before screening or for whom NPS cannot be determined accurately on endoscopy due to anatomic changes to the nasal cavity from past nasal/sinus surgery
  3. * Patients with conditions/concomitant diseases making them non evaluable for the primary efficacy endpoint
  4. * Signs or a CT scan suggestive of Allergic fungal rhinosinusitis
  5. * Active/chronic helminthic infection
  6. * History of human immunodeficiency virus (HIV) infection or positive HIV screen (Anti-HIV- and HIV-2 antibodies) at screening visit
  7. * Patients with positive or indeterminate hepatitis B surface antigen (HBsAg), hepatitis B core antibody (HBcAb), or hepatitis C antibody at screening visit 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 Locations (Sites)

Allergy & Rheumatology- Site Number : 8400005
La Jolla, California, 92037
United States
Sacramento Ear Nose & Throat - Roseville- Site Number : 8400003
Roseville, California, 95661
United States
Senta Clinic- Site Number : 8400025
San Diego, California, 92018
United States
James A Haley Veterans' Hospital- Site Number : 8400015
Tampa, Florida, 33612
United States
Emory University Hospital Midtown- Site Number : 8400012
Atlanta, Georgia, 30308
United States
The Allergy Group - Asthma & Allergy Boise- Site Number : 8400002
Boise, Idaho, 83706
United States
Harvard Medical School - Brigham and Women's Hospital Site Number : 8400016
Boston, Massachusetts, 02115
United States
Essential Medical Research- Site Number : 8400020
Tulsa, Oklahoma, 74137
United States
McGovern Medical School - UT Physicians Dermatology - Bellaire Station- Site Number : 8400017
Bellaire, Texas, 77401
United States
Gary Gross Pharmaceutical Research & Consulting, Inc. Site Number : 8400004
Dallas, Texas, 75231
United States
Berkson Medical - McKinney- Site Number : 8400014
McKinney, Texas, 75070
United States
Alamo ENT Associates Site Number : 8400001
San Antonio, Texas, 78258
United States
Advanced Research Institute - Odgen- Site Number : 8400022
Ogden, Utah, 84405
United States
Eastern Virginia Medical School (EVMS) Medical Group- Site Number : 8400008
Norfolk, Virginia, 23510
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 Date2024-07-17
Study Completion Date2027-04-09

Study Record Updates

Study Start Date2024-07-17
Study Completion Date2027-04-09

Terms related to this study

Additional Relevant MeSH Terms

  • Chronic Rhinosinusitis With Nasal Polyps