This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Eligibility
Sex
ALL
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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
Primary outcome measure(s)
Change From Baseline at Week 24 in Bilateral Nasal Polyp Score (NPS) — 24 weeks NPS is evaluated by nasal endoscopy. For each nostril, NPS is graded based on polyp size from 0 = no polyps to 4 = large polyps causing complete obstruction of inferior nasal cavity; lower score = smaller sized polyps. Bilateral NPS is the sum of right and left nostril scores, ranges from 0 (no polyps) to 8 (large polyps), higher score = more severe disease
Change From Baseline at Week 24 in Nasal Congestion Symptom Severity Score (NCS) — 24 weeks NCS is assessed by the participants daily from visit 1 and throughout the study on a scale of 0 to 3, where 0 = no symptoms, 1 = mild symptoms, 2 = moderate symptoms and 3 = severe symptoms, with higher scores indicates more severity.
Trial sites (1)
Facility
City
Region
Status
Site 01
Beijing
Beijing Municipality
More Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. trials in China
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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