Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:42 PM
Ignite Modification Date:
2025-12-24 @ 1:42 PM
NCT ID:
NCT06639295
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
75 Years
Study:
NCT06639295
Study Brief:
Protocol Section:
NCT06639295