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.
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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
230
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.
Research Site
Beijing, China
RECRUITINGTo describe changes from baseline in nasal polyp score (NPS)
Change from baseline in total NPS evaluated by nasal endoscopy at Week 24 NPS: score 0-4 for each item, 4 indicates worse outcome
Time frame: baseline-week24
To describe changes from baseline in participant-reported nasal congestion as evaluated by nasal congestion score (NCS)
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
Time frame: baseline-week24
To describe responder proportion in participant-reported nasal congestion as evaluated by the NCS following initiation of tezepelumab treatment
Proportion of NCS responders (minimal clinically important difference \[MCID\] from baseline = -1.0) at each collected timepoint. NCS: score 0-3, 3indicates worse outcome
Time frame: 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
Description of time to first response for NCS. NCS: score 0-3, 3indicates worse outcome
Time frame: 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
Change from baseline in NCS at each collected timepoint in daily score. NCS: score 0-3, 3indicates worse outcome
Time frame: Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24)
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To describe responder proportion in NPS following initiation of tezepelumab treatment
Proportion of participants with (i) ≥ 1 point reduction and (ii) ≥ 2 points reduction in NPS at Week 24. NPS: score 0-4 for each item, 4 indicates worse outcome
Time frame: Baseline, Weeks 0, 4, 12, and 24
To describe time to response in NPS following initiation of tezepelumab treatment
Description of time to first response for NPS (≥ 1 point reduction) NPS: score 0-4, 4 indicates worse outcome
Time frame: Baseline, Weeks 0, 4, 12, and 24
To describe changes in NPS following initiation of tezepelumab treatment
Change from baseline over time in NPS evaluated by nasal endoscopy through Week 24. NPS: score 0-4, 4 indicates worse outcome
Time frame: Baseline, Weeks 0, 4, 12, and 24
To describe numbers of CRSwNP exacerbation following initiation of tezepelumab treatment
* Description of numbers of CRSwNP exacerbation during treatment period (Week 0 to 24) at Week 24 * Description of annualized CRSwNP exacerbation rate
Time frame: 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
Proportion of SNOT-22 responder (MCID from baseline=-8.9) at each collected timepoint. SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: 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
Description of time to first response for SNOT-22. SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: 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
Change from baseline in SNOT-22 at each collected timepoint. SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
To describe changes in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Change from baseline visit in NB measured by PNIF. Higher PNIF values indicate improved nasal airflow.
Time frame: Weeks 0, 4, 12, and 24
To describe responder proportion in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Proportion of PNIF responder (MCID from baseline = 20 L/min)
Time frame: Weeks 0, 4, 12, and 24
To describe time to responder in nasal blockage (NB) as evaluated by peak nasal inspiratory flow (PNIF)
Description of time to first response for PNIF
Time frame: Weeks 0, 4, 12, and 24
To describe responder proportion in sense of smell as evaluated as part of the NPSD
* Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24 * Changes from baseline in loss of smell at all collected time points (daily)
Time frame: Baseline-Week24
To describe time to responder in sense of smell as evaluated as part of the NPSD.
* Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24 * Changes from baseline in loss of smell at all collected time points (daily)
Time frame: Baseline-Week24
To describe changes in sense of smell as evaluated as part of the NPSD
* Change from baseline in bi-weekly mean loss of smell evaluated as part of the NPSD at Week 24 * Changes from baseline in loss of smell at all collected time points (daily)
Time frame: Baseline-Week24
To describe responder proportion in sleep as evaluated by SNOT-22 sleep domain following initiation of tezepelumab treatment
Proportion of SNOT-22 sleep domain responders (MCID from baseline = -2.9). SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: 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
Description of time to first response for SNOT-22 sleep domain . SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: 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
Changes from baseline in SNOT-22 sleep domain score。 SNOT-22: score 0-5 for each item, 5 means worse outcome
Time frame: 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
Proportion of TSS responder (MCID from baseline = -4.0)
Time frame: 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
Description of time to first response for TSS
Time frame: 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
Changes from baseline in TSS in daily score
Time frame: 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
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
To describe the change on sinus opacification following initiation of tezepelumab.
Change from baseline in Lund-Mackay score (LMK) evaluated by CT at Week 24 as determined by the central reader. Lund-Mackay score: 0-12 each item, 12 means worse outcome
Time frame: Baseline, Week 24
To describe the change in lung function with co-morbid asthma following initiation of tezepelumab.
Change from baseline in pre-BD FEV1 at Week 24
Time frame: Baseline, Week12, Week24
To describe the change in ACQ-5 in participants with co-morbid asthma following initiation of tezepelumab.
* Change from baseline in ACQ-5 at Week 24. * The ACQ-5 total score is the mean of the 5 responses. Mean scores of ≤ 0.75 indicate well-controlled asthma, scores between 0.75 and \< 1.5 indicate partly controlled asthma, and a score ≥ 1.5 indicates not well-controlled asthma. Individual changes of at least 0.5 are considered to be clinically meaningful.
Time frame: Week0 and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Description of numbers of asthma exacerbation in participants with comorbid asthma during treatment period (Week 0-24) at Week 24
Time frame: week0-24
To describe responder proportion for NP control following initiation of tezepelumab
Description of time to first response for NP control
Time frame: Weeks 0, 4, 8, 12, 16, 20, and 24
To describe the change in asthma exacerbation in participants with co-morbid asthma following initiation of tezepelumab.
Description of AAER in participants with comorbid asthma
Time frame: week0-24