Phase 3: testing Tezepelumab for Chronic Rhinosinusitis With Nasal Polyps

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Tezepelumab. The registry lists allocation as na. 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.

They plan to enroll about 230 people at 28 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Tezepelumab

Primary outcome (registry wording): To describe changes from baseline in nasal polyp score (NPS)

Who it is for (from inclusion criteria)

• Ages 18 Years to any
• 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
• 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