A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab (BIFANG)

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

This is a multicentre, open-label, 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.

Study Overview

• Status: Recruiting
• Conditions: Chronic Rhinosinusitis With Nasal Polyps
• Intervention / Treatment: Drug: Tezepelumab

Detailed Description

This is a multicentre, open-label, 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.

The study aims to enrol approximately 230 participants from approximately 30-50 sites in China. To ensure that participants' inflammatory endotypes of disease are represented appropriately in this study, restrictive inclusion criteria will be adopted to ensure that all participants have an eosinophilic endotype (defined by JESREC score of ≥ 11), with approximately 30% of participants having a JESREC score of ≥ 15. Eligible participants will receive tezepelumab at a fixed dose of 210 mg subcutaneously (SC) using an accessorised pre-filled syringe (APFS) every four weeks for up to 24 weeks.

• Study Type: Interventional
• Enrollment (Estimated): 230
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: AstraZeneca Clinical Study Information Center; Phone Number: 1-877-240-9479; Email: information.center@astrazeneca.com

Study Locations

• China
  • Beijing, China, 100730
    • Recruiting
    • Research Site

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Age

  1. Participant must be 18 years of age or older, at the time of signing the informed consent.

• Type of Participant and Disease Characteristics 2. Participants who are with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:
• Severity consistent with the need for surgery as defined by total NPS ≥ 4 (at least 2 for each nostril) at screening, as determined by the central reader
• Mean NCS ≥ 2 in the 2 weeks prior to Visit 2
• Ongoing documented NP symptoms for > 8 weeks prior to screening such as rhinorrhoea, reduction or loss of smell and/or poor quality/loss of sleep

• SNOT-22 total score ≥ 30 as assessed at screening. 3. Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also ensure that participants are compliant and on a stable dose of the background INCS during study period.

  4. Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance or intolerance to surgery) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance or intolerance to surgery).

  5. Participants with JESREC score of ≥ 11.

• Weight 6. Body weight of ≥ 40 kg at Visit 1.
• Sex and Contraceptive/Barrier Requirements 7. Male and/or female

Female participants:

• Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non-childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
• Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first tezepelumab administration without an alternative medical cause.

• The following age-specific requirements apply:

  • Women < 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels within the postmenopausal range.
  • Women > 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.

• WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:

  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)
  • Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  • Cessation of contraception after this point should be discussed with a responsible physician.
• Informed Consent 8. Provision of signed and dated written ICF prior to any mandatory study-specific procedures, sampling, and analyses.

Exclusion Criteria:

Participants are excluded from the study if any of the following criteria apply:

-Medical Conditions

1. Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
2. Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.

3. Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

   • Affect the safety of the participant throughout the study
   • Influence the findings of the study or the interpretation
   • Impede the participant's ability to complete the entire duration of study
4. Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.

5. Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:

   • Antrochoanal polyps
   • Nasal septal deviation that occludes at least one nostril
   • Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome

6. History of cancer:

   • Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1
   • Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1
7. Uncontrolled epistaxis within 2 months of Visit 1.
8. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
9. For participants with comorbid asthma: Current smokers or participants with a smoking history > 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of < 10 packs per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
10. History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
11. Tuberculosis requiring treatment within the 12 months prior to Visit 1. Particpiants who in the opinion of the investigator have evidence of active tuberculosis (TB), either treated or untreated, or latent TB without completion of an appropriate course of treatment or appropriate ongoing prophylactic treatment. Evaluation will be according to the local standard of care as determined by local guidelines and may consist of medical history and physical examinations, chest x-ray, sputum stain and/or culture, and/or TB test (eg, purified protein derivative or QuantiFeron test).
12. Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.
13. History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.

14. Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.

    -Prior/Concomitant Therapy

15. Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longer) prior to Visit 1.
16. Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
17. Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
18. Receipt of live attenuated vaccines 30 days prior to the date of Visit 1 and during the study including the follow-up period.
19. Known history of sensitivity to any component of the tezepelumab formulation or a history of drug or other allergy that, in the opinion of the investigator or medical monitor, contraindicates their participation.
20. History of anaphylaxis or documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy.
21. Regular use of decongestants (topical or systemic) from Visit 1 onward is not allowed unless used for endoscopic procedure.
22. Use of corticosteroid-eluting intranasal stents within 6 months prior to Visit 1 and during the study period.

23. Recent aspirin desensitisation within 6 months of enrolment.

    -Prior/Concurrent Clinical Study Experience

24. Concurrent enrolment in another clinical study involving a study intervention.

    -Diagnostic Assessments

25. Any clinically meaningful abnormal finding in physical examination, haematology, or clinical chemistry at Visit 1 which, in the opinion of the investigator, may put the participant at risk because of his/her participation in the study, or may influence the results of the study, or the participant's ability to complete the entire duration of the study.
26. Evidence of active liver disease, including jaundice or AST, ALT, or ALP > 2 times ULN at Visit 1.

27. Positive hepatitis B surface antigen, or hepatitis C antibody serology at screening, or a positive medical history for hepatitis B or C. Participants with a history of hepatitis B vaccination without a history of hepatitis B are allowed to participate.

    -Other Exclusions

28. Participants with JESREC score of <11
29. Involvement in the planning and/or conduct of the study (applies to both AstraZeneca staff and/or staff at the study site), or participants employed by or relatives of the relatives of the employees of the site or sponsor.
30. Judgment by the investigator that the participant should not participate in the study if the participant is unlikely to comply with study procedures, restrictions, and requirements.
31. For women only: Pregnant, breastfeeding, or lactating women. A serum β-HCG pregnancy test must be drawn for WOCBP at the screening visit. If the results of the serum β-HCG cannot be obtained prior to dosing of the tezepelumab, a participant may be enrolled on the basis of a negative urine pregnancy test, though serum β-HCG must still be obtained. If either test is positive, the participant should be excluded. Since urine and serum tests may miss a pregnancy in the first days after conception, relevant menstrual history and sexual history, including methods of contraception, should be considered. Any participant whose menstrual and/or sexual history suggests the possibility of early pregnancy should be excluded.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Intervention Arm; This is a multicentre, open-label, single-arm, Phase 3b study, all participants will be grouped into the same group for the study intervention.

Drug: Tezepelumab; At Visit 2 (Week 0), participants who meet the inclusion and exclusion criteria will receive tezepelumab treatment. All participants will receive tezepelumab 210 mg SC every four weeks (Q4W) from Week 0 (Visit 2), with the last dose administered at Week 20 (Visit 7). All tezepelumab administration will occur at the study site. Each participant who completes the study without discontinuing study intervention will receive a total of 6 doses of tezepelumab.; Other Names: TEZSPIRE®

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe changes from baseline in nasal polyp score (NPS)	Change from baseline in total NPS evaluated by nasal endoscopy at Week 24 NPS: score 0-4 for each item, 4 indicates worse outcome	baseline-week24
To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)	Change from baseline in bi-weekly mean nasal congestion score (NCS) evaluated as part of the Nasal Polyposis Symptom Diary (NPSD) at Week 24. NCS: score 0-3, 3 indicates worse outcome	baseline-week24

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment	Proportion of NCS responders (minimal clinically important difference [MCID] from baseline = -1.0) at each collected timepoint. NCS: score 0-3, 3indicates worse outcome	Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)
To describe time to response and changes in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment	Description of time to first response for NCS. NCS: score 0-3, 3indicates worse outcome	Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)
To describe changes in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment	Change from baseline in NCS at each collected timepoint in daily score. NCS: score 0-3, 3indicates worse outcome	Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)
To describe responder proportion in NPS following initiation of tezepelumab treatment	Proportion of participants with (i) ≥ 1 point reduction and (ii) ≥ 2 points reduction in NPS at Week 24. NPS: score 0-4 for each item, 4 indicates worse outcome	Baseline, Weeks 0, 4, 12, and 24
To describe time to response in NPS following initiation of tezepelumab treatment	Description of time to first response for NPS (≥ 1 point reduction) NPS: score 0-4, 4 indicates worse outcome	Baseline, Weeks 0, 4, 12, and 24
To describe changes in NPS following initiation of tezepelumab treatment	Change from baseline over time in NPS evaluated by nasal endoscopy through Week 24. NPS: score 0-4, 4 indicates worse outcome	Baseline, Weeks 0, 4, 12, and 24
To describe numbers of CRSwNP exacerbation following initiation of tezepelumab treatment	Description of numbers of CRSwNP exacerbation during treatment period (Week 0 to 24) at Week 24; Description of annualized CRSwNP exacerbation rate	Baseline, Weeks 0, 4, 12, and 24
To describe responder proportion in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment	Proportion of SNOT-22 responder (MCID from baseline=-8.9) at each collected timepoint. SNOT-22: score 0-5 for each item, 5 means worse outcome	Weeks 0, 4, 8, 12, 16, 20, and 24
To describe time to first response in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment	Description of time to first response for SNOT-22. SNOT-22: score 0-5 for each item, 5 means worse outcome	Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) total score following initiation of tezepelumab treatment	Change from baseline in SNOT-22 at each collected timepoint. SNOT-22: score 0-5 for each item, 5 means worse outcome	Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)	Change from baseline visit in NB measured by PNIF. Higher PNIF values indicate improved nasal airflow.	Weeks 0, 4, 12, and 24
To describe responder proportion in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)	Proportion of PNIF responder (MCID from baseline = 20 L/min)	Weeks 0, 4, 12, and 24
To describe time to responder in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)	Description of time to first response for PNIF	Weeks 0, 4, 12, and 24
To describe responder proportion in sense of smell as evaluated as part of the NPSD	Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24; Changes from baseline in loss of smell at all collected time points (daily)	Baseline-Week24
To describe time to responder in sense of smell as evaluated as part of the NPSD.	Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24; Changes from baseline in loss of smell at all collected time points (daily)	Baseline-Week24
To describe changes in sense of smell as evaluated as part of the NPSD	Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24; Changes from baseline in loss of smell at all collected time points (daily)	Baseline-Week24
To describe responder proportion in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment	Proportion of SNOT-22 sleep domain responders (MCID from baseline = -2.9). SNOT-22: score 0-5 for each item, 5 means worse outcome	Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe time to responder in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment	Description of time to first response for SNOT-22 sleep domain . SNOT-22: score 0-5 for each item, 5 means worse outcome	Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment	Changes from baseline in SNOT-22 sleep domain score。 SNOT-22: score 0-5 for each item, 5 means worse outcome	Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe responder proportion in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab	Proportion of TSS responder (MCID from baseline = -4.0)	Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe time to responder in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab	Description of time to first response for TSS	Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe changes in overall symptoms as evaluated by NPSD total nasal symptom score (TSS) following initiation of tezepelumab	Changes from baseline in TSS in daily score	Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe responder proportion for NP control following initiation of tezepelumab	Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question	Weeks 0, 4, 8, 12, 16, 20, and 24
To describe the change on sinus opacification following initiation of tezepelumab.	Change from baseline in Lund-Mackay score (LMK) evaluated by CT at Week 24 as determined by the central reader. Lund-Mackay score: 0-12 each item, 12 means worse outcome	Baseline, Week 24
To describe the change in lung function with co-morbid asthma following initiation of tezepelumab.	Change from baseline in pre-BD FEV1 at Week 24	Baseline, Week12, Week24
To describe the change in ACQ-5 in participants with co-morbid asthma following initiation of tezepelumab.	Change from baseline in ACQ-5 at Week 24.; The ACQ-5 total score is the mean of the 5 responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and < 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.	Week0 and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.	Description of numbers of asthma exacerbation in participants with comorbid asthma during treatment period (Week 0-24) at Week 24	week0-24
To describe responder proportion for NP control following initiation of tezepelumab	Description of time to first response for NP control	Weeks 0, 4, 8, 12, 16, 20, and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.	Description of AAER in participants with comorbid asthma	week0-24

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
To evaluate the safety and tolerability of tezepelumab	Adverse events (AEs), Serious adverse events(SAEs), Discontinuations of study intervention due to an AE(DAEs), AE of special interest(AESIs)	week0-24
To evaluate the need for nasal polyp surgery up to Week 24	Time to NP surgery decision up to Week 24	Baseline-Week24
To evaluate the need for SCS use up to Week 24	Description of SCS use up to Week 24	Baseline-Week24

Collaborators and Investigators

• Sponsor: AstraZeneca
• Investigators: Principal Investigator: Luo Zhang, Professor, Beijing Tongren Hospital, CMU

Study record dates

Study Major Dates

• Study Start (Actual): April 24, 2026
• Primary Completion (Estimated): March 1, 2028
• Study Completion (Estimated): March 7, 2028

Study Registration Dates

• First Submitted: March 24, 2026
• First Submitted That Met QC Criteria: April 2, 2026
• First Posted (Actual): April 9, 2026

Study Record Updates

• Last Update Posted (Actual): May 26, 2026
• Last Update Submitted That Met QC Criteria: May 22, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: CRSwNP(Chronic Rhinosinusitis with Nasal Polyps)
• Additional Relevant MeSH Terms: tezepelumab
• Other Study ID Numbers: D5242L00001

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment:https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.
• IPD Sharing Time Frame: AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
• IPD Sharing Access Criteria: When a request has been approved, AstraZeneca will provide access to the anonymized individual patient-level data via secure research environment Vivli.org. Signed Data Usage Agreement (non-negotiable contract for data accessors) must be in place before accessing requested information
• IPD Sharing Supporting Information Type: STUDY_PROTOCOL

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No