A Study to Evaluate 611 in Patients with Chronic Rhinosinusitis with Nasal Polyps

Launched by SUNSHINE GUOJIAN PHARMACEUTICAL (SHANGHAI) CO., LTD. · Oct 10, 2024

Keywords

ClinConnect Summary

This clinical trial is studying a new treatment, called 611, for patients suffering from chronic rhinosinusitis with nasal polyps (CRSwNP). This condition causes inflammation in the sinuses and the growth of polyps (small, noncancerous growths) in the nose, leading to symptoms like congestion and difficulty breathing. The goal of the study is to evaluate how effective and safe this treatment is for people who have not found relief from their symptoms despite previous treatments.

To participate in the trial, you must be between 18 and 75 years old and have been diagnosed with CRSwNP. You should have moderate to severe nasal congestion and polyps that have not improved with other medications or treatments in the past two years. The study is not yet recruiting, but once it starts, participants will be monitored closely to see how well the treatment works and if there are any side effects. If you meet the eligibility criteria and are interested in helping advance treatment options for this condition, this trial could be an opportunity to consider.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Female and male patients aged ≥18 and ≤ 75 years at the time of screening.
• • Bilateral CRSwNP.
• • Bilateral NPS of ≥5 with a minimum score of 2 in each nasal cavity
• • Nasal Congestion Score of 2 at screening and a weekly average severity of 2 at time of randomization.
• • Patients whose bilateral sino-nasal polyposis remains inadequately controlled despite prior treatment with SCS anytime within the past 2 years; and/or had a medical contraindication/intolerance to SCS; and/or received nasal polyp surgery 6 months before signing the ICF.
• Exclusion Criteria:
• • Patients with other nasal diseases or symptoms.
• • Patients who are taking or have taken the following prohibited therapies as specified, e.g., systemic steroids within 4 weeks prior to screening, less than 3 months or 5 half-lives for biologic therapy prior to screening.
• • Patients who have active Hepatitis B, Hepatitis C or HIV infections as determined by positive results at Screening.
• • History of cancer.
• • Known or suspected history of immunosuppression.
• • Known with allergic or intolerant to mometasone furoate spray or 611/ placebo