A Study to Investigate NPS and Symptoms in Chinese Adult Participants With CRSwNP Initiating Treatment With Tezepelumab
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18+
SponsorAstraZeneca
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
Age
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
Disqualifiers
Participants with documented allergic fungal rhinosinusitis and/or central compartment atopic disease.
Any clinically important pulmonary disease other than asthma (eg, active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc) that could confound interpretation of clinical CRSwNP endpoints results.
Affect the safety of the participant throughout the study
Influence the findings of the study or the interpretation
Trial design
Design model
Single group
Treatments tested in this trial
Tezepelumab
DrugAt 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.
Treatment groups
230 Participants
are divided into 1 treatment groupGroup A: Intervention ArmExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
To 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-week242
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-week24Secondary outcomes
1
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)2
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)3
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)4
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 24Other outcomes
1
To evaluate the safety and tolerability of tezepelumab
Adverse events (AEs), Serious adverse events(SAEs), Discontinuations of study intervention due to an AE(DAEs), AE of special interest(AESIs)
Time frame
week0-242
To evaluate the need for nasal polyp surgery up to Week 24
Time to NP surgery decision up to Week 24
Time frame
Baseline-Week243
To evaluate the need for SCS use up to Week 24
Description of SCS use up to Week 24
Time frame
Baseline-Week244
To evaluate the changes in key type 2 inflammatory mediators in the serum following initiation of tezepelumab
Changes in concentration levels of inflammatory cytokines \[TT22.1\]\[AX22.2\]in serum from baseline to Week 24: IL-5, IL-13, EDN by ELISA, summarized by mean change
Time frame
Baseline and the Week 24Sponsors and contacts
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Source ClinicalTrials.gov