Recruiting
Sponsor ID
D5242L00001

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

Sponsor ID
D5242L00001
Clinicaltrials.gov ID
NCT07520162
EUCTIS ID
N/A
EudraCT ID
N/A

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.

Additional Study Details

Phase
Phase 3
Product
N/A
Type
Interventional
Masking
N/A
Enrollment
230
Additional Study Details

Protocol Summary

Primary Outcome Measures

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

Secondary Outcome Measures

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

Locations

Location
Status
Contact Us
Location
Research Site
Beijing, China, 100034
Status
Recruiting
Location
Research Site
Beijing, China, 100191
Status
Not yet recruiting
Location
Research Site
Beijing, China, 100730
Status
Recruiting
Location
Research Site
Bengbu, China
Status
Not yet recruiting
Location
Research Site
Cangzhou, China, 061000
Status
Recruiting
Location
Research Site
Changchun, China
Status
Not yet recruiting
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