Actively Recruiting
A Multicentre, Randomised, Double-Blind, Placebo-Controlled, Parallel-Group Phase 3 Efficacy and Safety Study of SHR-1905 in Patients With Chronic Rhinosinusitis With Nasal Polyps
Led by Guangdong Hengrui Pharmaceutical Co., Ltd · Updated on 2025-11-17
280
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of SHR-1905 injection in adults with chronic rhinosinusitis with nasal polyps (CRSwNP), a condition where nasal polyps cause persistent symptoms. This Phase 3, randomized, double-blind, placebo-controlled study aims to assess how well SHR-1905 works and its safety profile compared to placebo in this patient group. Participants are randomly assigned to receive either SHR-1905 injection or a placebo injection. The treatment period lasts 24 weeks, during which nasal polyp scores and nasal congestion scores are closely monitored. The study also measures other outcomes like sinus CT scan scores, sense of smell, symptom questionnaires, and overall symptom scores to comprehensively evaluate the treatment effects. Throughout the 24-week study, participants undergo regular assessments including nasal polyp scoring, nasal congestion evaluation, sinus imaging, and symptom questionnaires such as the Sino-nasal Outcome Test-22. Researchers carefully monitor safety and collect data to understand how SHR-1905 impacts symptoms and quality of life. The total duration of participation aligns with the 24-week treatment and evaluation period.
CONDITIONS
Brief 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 at least 40 kg
- Diagnosed with chronic rhinosinusitis with nasal polyps (CRSwNP)
- Bilateral nasal polyps with total nasal polyp score of 5 or more, and at least 2 points for each nostril
- Nasal congestion score of 2 or higher at screening and baseline
- Sino-nasal outcome test-22 (SNOT-22) score of 30 or more 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 with contraindications or intolerances to these treatments
You will not qualify if you...
- Any other health conditions that may affect nasal polyp evaluation
- Any other health conditions except asthma that may affect blood eosinophil levels
- Immunodeficiency
- Contraindications or unsuitability for nasal endoscopy
- Uncontrolled high blood pressure or uncontrolled 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 polyp scoring
- Cancer diagnosed within 5 years before randomization except low-risk types
- Abnormal laboratory test results at screening or baseline
- Active hepatitis B, positive hepatitis C, HIV, or syphilis infection
- Prolonged QTc interval or other significant ECG abnormalities at screening or baseline
- Lung function (FEV1) less than 50% before bronchodilator use at screening
- Blood transfusion or immunoglobulin 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
- Smoking at screening or quit smoking less than 6 months before screening
- Substance abuse, drug 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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 24 weeks
Participants receive SHR-1905 or placebo injections to treat chronic rhinosinusitis with nasal polyps.
Multiple visits during the 24 weeks of treatment
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
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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