Trials / Active Not Recruiting
Active Not RecruitingNCT06639295
A Study to Evaluate 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps
A Multicenter, Randomized, Double-blind, Placebo-controlled, Phase III Clinical Study to Evaluate the Efficacy and Safety of 611 in Patients With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)
- Status
- Active Not Recruiting
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 243 (actual)
- Sponsor
- Sunshine Guojian Pharmaceutical (Shanghai) Co., Ltd. · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
This study will evaluate the effect and safety of 611 in patients with Chronic Rhinosinusitis with Nasal Polyps (CRSwNP)
Detailed description
The main purpose is to evaluate the effect of 611 on a background of mometasone furoate nasal spray (MFNS) in reducing endoscopic nasal polyp score (NPS) and nasal congestion/obstruction score (NCS) severity in eligible patients with CRSwNP whose disease remains inadequately controlled despite daily treatment with intranasal corticosteroid (INCS) therapy in comparison to placebo
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | 611 | 611 subcutaneous (SC) injection. |
| DRUG | Placebo | Placebo subcutaneous (SC) injection. |
Timeline
- Start date
- 2024-11-22
- Primary completion
- 2025-12-01
- Completion
- 2026-08-01
- First posted
- 2024-10-15
- Last updated
- 2025-12-03
Locations
1 site across 1 country: China
Source: ClinicalTrials.gov record NCT06639295. Inclusion in this directory is not an endorsement.