Actively Recruiting
Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-11-17
280
Participants Needed
1
Research Sites
135 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the efficacy, and safety of SHR-1905 injection in subjects with chronic rhinosinusitis with nasal polyps (CRSwNP)
CONDITIONS
Official Title
Efficacy and Safety of SHR-1905 Injection in Subjects With Chronic Rhinosinusitis With Nasal Polyps
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Weight 40 kg or more
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP)
- Bilateral nasal polyps at screening and baseline, total nasal polyp score 5 or higher, with 2 or more points for each nostril
- Nasal congestion score 2 or higher at screening and baseline
- SNOT-22 score 30 or higher at screening and baseline
- Persistent nasal polyp symptoms for over 4 weeks before screening
- Received standard intranasal corticosteroid therapy before randomization
- History of nasal polyp surgery and/or systemic corticosteroid use within 1 year before screening, or has contraindications or intolerance to these treatments
You will not qualify if you...
- Any health conditions that may affect nasal polyp treatment evaluation
- Any health conditions except asthma that may affect blood eosinophil levels
- Immunodeficiency
- Contraindications or unsuitability for nasal endoscopy
- Uncontrolled high blood pressure or diabetes
- Infection within 4 weeks before randomization
- Uncontrolled nosebleeds within 4 weeks before randomization
- Major surgery within 3 months before randomization or planned surgery during the study
- Parasitic infection within 6 months before randomization
- Sinus or nasal surgery within 6 months before screening or nasal changes preventing nasal polyp evaluation
- Cancer diagnosed within 5 years before randomization, except low risk types
- Abnormal lab tests at screening or baseline
- Active hepatitis B, hepatitis C, HIV, or syphilis infections
- Prolonged QTc interval or significant abnormal ECG results at screening or baseline
- Lung function (FEV1) less than 50% before bronchodilator use at screening
- Blood transfusion or immunoglobulin use within 4 weeks before randomization
- Use of systemic corticosteroids or additional intranasal corticosteroids within 4 weeks before randomization or planned use during treatment
- Regular use of decongestants within 4 weeks before randomization, except during endoscopy
- Live or viral vector vaccine within 4 weeks before randomization
- Allergen immunotherapy within 8 weeks before randomization
- Current smoking or quit less than 6 months before screening
- Substance abuse or excessive alcohol use within 1 year before randomization
- Pregnancy, breastfeeding, or planning pregnancy during the study period
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Eye & Ent Hospital of Fudan University
Shanghai, Shanghai Municipality, China, 200031
Actively Recruiting
Research Team
H
HuanHuan Huang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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