Actively Recruiting
BIFANG: A Multicentre, Single-Arm, Phase 3b Study to Assess Nasal Polyps Score and Symptoms in Chinese Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Led by AstraZeneca · Updated on 2026-05-26
230
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the nasal polyps score and symptoms in Chinese adults with chronic rhinosinusitis with nasal polyposis (CRSwNP) who begin treatment with tezepelumab. This Phase 3b, multicentre, open-label, single-arm study includes about 230 adults who have an eosinophilic type of this disease, defined by a JESREC score of 11 or higher, with about 30% having an even higher score of 15 or more. The study is sponsored by AstraZeneca and is designed to better understand how tezepelumab affects nasal polyps and related symptoms over time. Eligible participants will receive a fixed dose of 210 mg tezepelumab given as a subcutaneous injection every four weeks for 24 weeks, totaling six doses. All doses will be administered at the study sites. Since this is a single-arm study, all participants receive the same treatment without comparison to a placebo or other drug. The study specifically includes participants who have severe nasal polyps requiring surgery and ongoing symptoms despite standard treatments like intranasal corticosteroids. Participants will be closely monitored throughout the study from baseline to week 24. Researchers will assess changes in nasal polyp scores, nasal congestion, sino-nasal symptoms, sleep quality, sense of smell, and lung function for those with asthma. These assessments include patient questionnaires, nasal polyp scoring by central readers, peak nasal inspiratory flow measurements, and monitoring of exacerbations. The study also involves safety monitoring and will document participant responses over the treatment period to better understand tezepelumab's effects on CRSwNP symptoms and disease control.
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 before screening.
- Total nasal polyp score (NPS) of 4 or higher, 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 before screening, such as rhinorrhoea, loss of smell, or poor sleep.
- 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 within the past 12 months, or contraindications/intolerance to surgery.
- JESREC score of 11 or higher.
- Body weight of at least 40 kg at screening.
- Male or female; women of childbearing potential must use effective contraception during the study and for 16 weeks after last dose.
- Signed and dated informed consent form prior to any study procedures.
You will not qualify if you...
- Allergic fungal rhinosinusitis or central compartment atopic disease.
- Significant lung diseases other than asthma that could affect study results.
- Unstable major health conditions affecting safety or ability to complete the study.
- Sinus surgery within 6 months before screening or past surgery that affects nasal polyp scoring.
- Conditions such as antrochoanal polyps, severe nasal septal deviation, acute sinus or respiratory infections at screening.
- History of cancer within certain timeframes, except certain skin or cervical cancers treated over a year ago.
- Uncontrolled nosebleeds within 2 months before screening.
- Untreated or recent helminth parasitic infection.
- Current smokers with asthma or heavy smoking history.
- Recent alcohol or drug abuse.
- Tuberculosis requiring treatment within 12 months before screening or active TB.
- Major surgery within 8 weeks before screening or planned surgery during the study.
- Known immunodeficiency including positive HIV.
- Recent infection requiring systemic antibiotics.
- Recent use of biologic or immunosuppressive drugs.
- Receipt of immunoglobulin or blood products recently.
- Recent live vaccines.
- Known allergies to tezepelumab or related drugs.
- History of severe allergic reactions to biologics.
- Regular use of decongestants during the study.
- Use of corticosteroid-eluting nasal stents recently or during study.
- Recent aspirin desensitisation.
- Participation in another clinical trial involving treatment.
- Abnormal physical or lab findings that risk safety or affect results.
- Active liver disease or positive hepatitis B or C tests.
- JESREC score below 11.
- Involvement with study planning or staff, or close relation to staff or sponsor.
- Unlikely to comply with study requirements.
- Pregnant, breastfeeding, or lactating women; positive pregnancy tests at screening.
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.
Participants complete screening procedures to confirm eligibility based on nasal polyp severity and other health criteria.
Duration - Up to 24 weeks
Participants receive tezepelumab 210 mg subcutaneously every four weeks for up to 24 weeks to assess changes in nasal polyps and symptoms.
6 visits for tezepelumab administration at the study site, occurring every four weeks from Week 0 to Week 20
Trial Site Locations
Total: 1 location
1
Research Site
Beijing, China, 100730
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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