A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With TezepelumabBIFANG
Study Details
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.
Protocol Summary
To describe changes from baseline in nasal polyp score (NPS)
Timeframe: baseline-week24
To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)
Timeframe: baseline-week24
To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Baseline, Weeks 0, 4, 12, and 24
To describe time to response in NPS following initiation of tezepelumab treatment
Timeframe: Baseline, Weeks 0, 4, 12, and 24
To describe changes in NPS following initiation of tezepelumab treatment
Timeframe: Baseline, Weeks 0, 4, 12, and 24
To describe numbers of CRSwNP exacerbation following initiation of tezepelumab treatment
Timeframe: 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
Timeframe: Baseline, 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
Timeframe: Baseline, 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
Timeframe: Baseline, Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Timeframe: Weeks 0, 4, 12, and 24
To describe responder proportion in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Timeframe: Weeks 0, 4, 12, and 24
To describe time to responder in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Timeframe: Weeks 0, 4, 12, and 24
To describe responder proportion in sense of smell as evaluated as part of the NPSD
Timeframe: Baseline-Week24
To describe time to responder in sense of smell as evaluated as part of the NPSD.
Timeframe: Baseline-Week24
To describe changes in sense of smell as evaluated as part of the NPSD
Timeframe: Baseline-Week24
To describe responder proportion in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: 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
Timeframe: Daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
To describe the change on sinus opacification following initiation of tezepelumab.
Timeframe: Baseline, Week 24
To describe the change in lung function with co-morbid asthma following initiation of tezepelumab.
Timeframe: Baseline, Week12, Week24
To describe the change in ACQ-5 in participants with co-morbid asthma following initiation of tezepelumab.
Timeframe: Baseline and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Timeframe: week0-24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Timeframe: week0-24