NCT07520162

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

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

• Status: Not Yet Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 230 (estimated)
• Sponsor: AstraZeneca · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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

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.

Conditions

• Chronic Rhinosinusitis With Nasal Polyps

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2026-05-06
• Primary completion: 2028-03-07
• Completion: 2028-08-15
• First posted: 2026-04-09
• Last updated: 2026-04-09

Locations

51 sites across 1 country: China