Actively Recruiting
Phase 3b Study Evaluating Tezepelumab Treatment for Nasal Polyps and Symptoms in Chinese Adults with Chronic Rhinosinusitis with Nasal Polyps
Led by AstraZeneca · Updated on 2026-08-12
230
Participants Needed
21
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying chronic rhinosinusitis with nasal polyps CRSwNP in Chinese adults to assess nasal polyps score and symptom changes after starting treatment with tezepelumab. This Phase 3b, open-label, single-arm study focuses on participants with an eosinophilic type of CRSwNP, as defined by a specific JESREC score. About 230 participants will be enrolled from multiple sites across China to evaluate this treatments impact on their condition. Eligible participants will receive a fixed dose of tezepelumab 210 mg administered subcutaneously every four weeks for up to 24 weeks, totaling six doses. All doses will be given at the study sites. This study uses a single group design where all participants receive the same treatment, aiming to observe changes over time without a comparison group. Participants will be involved for about 24 weeks during which researchers will assess nasal polyp scores and nasal congestion changes from baseline to the end of treatment. They will also monitor symptom improvements using various patient-reported measures and clinical tests at multiple time points throughout the study. Safety and response to treatment will be carefully tracked to understand tezepelumabs effects on nasal polyps and related symptoms.
CONDITIONS
Brief Title
A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participant must be 18 years of age or older at the time of signing the informed consent.
- Physician-diagnosed chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 12 months prior to screening.
- Total nasal polyp score (NPS) of 4 or higher at screening, with at least 2 in each nostril.
- Mean nasal congestion score (NCS) of 2 or higher in the 2 weeks before treatment start.
- Ongoing nasal polyp symptoms for more than 8 weeks prior to screening, such as runny nose, reduced or lost sense of smell, or poor sleep quality.
- SNOT-22 total score of 30 or higher at screening.
- Stable treatment with intranasal corticosteroids for at least 30 days before screening.
- History of nasal polyp exacerbation treated with systemic corticosteroids or surgery, or intolerance/contraindication to surgery.
- JESREC score of 11 or higher.
- Body weight of 40 kg or more at screening.
- Male or female participants; women of childbearing potential must use effective contraception during the study and for 16 weeks after last dose.
- Provision of signed informed consent before any study procedures.
You will not qualify if you...
- Allergic fungal rhinosinusitis or central compartment atopic disease.
- Significant lung disease other than asthma that may affect study results.
- Unstable major disorders that could affect safety or study participation.
- Sinus surgery within 6 months before screening or previous surgery altering nasal anatomy preventing polyp scoring.
- Conditions like antrochoanal polyps, nasal septal deviation blocking a nostril, recent infections, or specific syndromes.
- History of cancer unless treated with curative therapy completed at least 12 months (skin or cervix cancers) or 5 years (other cancers) prior to screening.
- Uncontrolled nosebleeds within 2 months before screening.
- Untreated or recent helminth infections.
- Smoking history over 10 pack-years or recent vaping use in participants with asthma.
- History of alcohol or drug abuse within 12 months.
- Untreated or active tuberculosis.
- Major surgery within 8 weeks before screening or planned surgery during study.
- Known immunodeficiency or positive HIV test.
- Recent infection requiring antibiotics within 14 days before screening.
- Recent use of biologic or immunosuppressive drugs within specified time frames.
- Allergy or hypersensitivity to tezepelumab or study components.
- Regular use of decongestants or corticosteroid-eluting nasal stents near study start.
- Recent aspirin desensitization.
- Concurrent participation in another clinical study involving interventions.
- Abnormal lab or physical exam findings posing risk or affecting study.
- Positive hepatitis B or C infection.
- JESREC score below 11.
- Involvement in study planning or conduct or related employment.
- Likely non-compliance with study procedures.
- Pregnant, breastfeeding, or lactating women; positive pregnancy tests at screening.
Research Team
A
AstraZeneca Clinical Study Information Center
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