Clinical Trials/NCT07520162

NCT07520162

Not yet recruiting

Phase 3

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

AstraZeneca51 sites in 1 country230 target enrollmentStarted: May 6, 2026Last updated: April 9, 2026

ConditionsChronic Rhinosinusitis With Nasal Polyps

InterventionsTezepelumab

DrugsTezepelumab

Overview

Phase: Phase 3
Status: Not yet recruiting
Sponsor: AstraZeneca
Enrollment: 230
Locations: 51
Primary Endpoint: To describe changes from baseline in nasal polyp score (NPS)

Overview Study Design Eligibility Criteria Arms & Interventions Outcomes Investigators Sites Records & Identifiers Similar Trials

Overview

Brief Summary

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.

Detailed Description

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 Design

Study Type: Interventional
Allocation: Na
Intervention Model: Single Group
Primary Purpose: Treatment
Masking: None

Masking Description

None (Open Label)

Eligibility Criteria

Ages: 18 Years to — (Adult, Older Adult)
Sex: All
Accepts Healthy Volunteers: No

Inclusion Criteria

•1\. Participant must be 18 years of age or older, at the time of signing the informed consent.
•Type of Participant and Disease Characteristics
•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.
•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
•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).

Exclusion Criteria

•Participants are excluded from the study if any of the following criteria apply:
•Medical Conditions
•Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
•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.
•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
•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.
•Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:

Arms & Interventions

Intervention Arm

Experimental

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

Intervention: Tezepelumab (Drug)

Outcomes

Primary Outcomes

To describe changes from baseline in nasal polyp score (NPS)

Time Frame: baseline-week24

Change from baseline in total NPS evaluated by nasal endoscopy at Week 24 NPS: score 0-4 for each item, 4 indicates worse outcome

To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)

Time Frame: baseline-week24

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

Secondary Outcomes

To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment(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(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(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(Baseline, Weeks 0, 4, 12, and 24)
To describe time to response in NPS following initiation of tezepelumab treatment(Baseline, Weeks 0, 4, 12, and 24)
To describe changes in NPS following initiation of tezepelumab treatment(Baseline, Weeks 0, 4, 12, and 24)
To describe numbers of CRSwNP exacerbation following initiation of tezepelumab treatment(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(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(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(Weeks 0, 4, 8, 12, 16, 20, and 24)
To describe changes in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)(Weeks 0, 4, 12, and 24)
To describe responder proportion in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)(Weeks 0, 4, 12, and 24)
To describe time to responder in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)(Weeks 0, 4, 12, and 24)
To describe responder proportion in sense of smell as evaluated as part of the NPSD(Baseline-Week24)
To describe time to responder in sense of smell as evaluated as part of the NPSD.(Baseline-Week24)
To describe changes in sense of smell as evaluated as part of the NPSD(Baseline-Week24)
To describe responder proportion in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment(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(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(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(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(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(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(Weeks 0, 4, 8, 12, 16, 20, and 24)
To describe the change on sinus opacification following initiation of tezepelumab.(Baseline, Week 24)
To describe the change in lung function with co-morbid asthma following initiation of tezepelumab.(Baseline, Week12, Week24)
To describe the change in ACQ-5 in participants with co-morbid asthma following initiation of tezepelumab.(Week0 and 24)
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.(week0-24)

Investigators

Sponsor

AstraZeneca

Sponsor Class

Industry

Responsible Party

Sponsor

Study Sites (51)

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