Clinical Trials in China / NCT06639295
Active, not recruiting
Phase 3
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
NCT06639295 · tracked via the Priya Life Science China tracker
Condition(s) studied
SinusitisNasal Polyps
Investigational drug(s) / intervention(s)
611Placebo
611: 611 subcutaneous (SC) injection.
Placebo: Placebo subcutaneous (SC) injection.
Study summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Eligibility
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
Other trials for the same condition
Official registry record
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.
View NCT06639295 on ClinicalTrials.gov ↗ ← All trials in China