The main objective of this study is to evaluate treatment outcomes of tezepelumab among participants with physician-determined surgery-eligible CRSwNP, with or without asthma. Study details include: 1. The study duration will be up to 40 weeks. 2. The treatment duration will be up to 24 weeks. 3. The visit frequency will be once every 4 weeks (Q4W).
This is a multicentre, open-label, single-arm, phase IIIb study is to describe changes from baseline in (1) participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) and (2) participant-reported sino-nasal symptoms as evaluated by sino-nasal outcome test, 22 item (SNOT-22) following initiation of tezepelumab treatment. Approximately 60 sites in 10 countries will enrol adult patients with physician determined surgery eligible CRSwNP. The study is divided into 3 periods as described below: * Screening Period (from Week -4 until Week 0, up to 4 Weeks) * Treatment period (Week 0 to Week 24) * Safety Follow-up Period (Week 24 to Week 36)
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
180
IMP. Subcutaneous injection. Unit dose strengths 210 mg.
Change from baseline in nasal congestion
Changes from baseline in participant-reported nasal congestion as evaluated by the nasal congestion score (NCS) as part of the nasal polyposis symptom diary (NPSD) following initiation of tezepelumab treatment.
Time frame: Week 24
Change from baseline in sino-nasal symptoms
changes from baseline in participant reported sino nasal symptoms as evaluated by sino nasal outcome test, 22 item (SNOT 22) total score following initiation of tezepelumab treatment.
Time frame: Week 24
Proportion of NCS responders
Proportion of NCS responders (minimal clinically important difference \[MCID\] from baseline = 1.0) at each collected timepoint.
Time frame: End of treatment - Week 24
Time to first response for NCS
Description of time to first response for NCS by analysing data at all collected timepoints.
Time frame: End of Treatment-week 24
Change from baseline in NCS
Change from baseline in NCS at each collected timepoint.
Time frame: Daily for the 2 weeks prior to Week 0 through end of treatment visit (EOT; Week 24).
Proportion of SNOT-22 responders
Proportion of SNOT-22 responders (MCID from baseline = -8.9) at each collected timepoint.
Time frame: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Time to first response for SNOT-22
Description of time to first response for SNOT-22 by analysing data at all collected timepoints.
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Research Site
Newport Beach, California, United States
RECRUITINGResearch Site
Chicago, Illinois, United States
RECRUITINGResearch Site
Chestnut Hill, Massachusetts, United States
RECRUITINGResearch Site
Columbia, Missouri, United States
RECRUITINGResearch Site
Plovdiv, Bulgaria
RECRUITINGResearch Site
Sofia, Bulgaria
RECRUITINGResearch Site
Sofia, Bulgaria
WITHDRAWNResearch Site
Sofia, Bulgaria
RECRUITINGResearch Site
Hamilton, Ontario, Canada
RECRUITINGResearch Site
Québec, Quebec, Canada
RECRUITING...and 35 more locations
Time frame: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Change from baseline in SNOT-22
Change from baseline in SNOT-22 at each collected timepoint.
Time frame: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.
Change from baseline visit in nasal blockage (NB)
Change from baseline visit in NB measured by PNIF
Time frame: Weeks 0, 4, 12, and 24.
Change from baseline visit in NB
Change from baseline visit in NB measured by VAS-NB
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Proportion of PNIF responders
Proportion of PNIF responders (MCID from baseline =20 L/min).
Time frame: Weeks 0, 4, 12, and 24.
Proportion of VAS-NB responders
Proportion of VAS-NB responders (MCID from baseline = -3.0) (in participants with VAS-NB ≥ 7 at baseline).
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Time to first response for PNIF
Description of time to first response for PNIF by analysing data at all collected timepoints.
Time frame: Weeks 0, 4, 12, and 24
First response for VAS NB
Description of time to first response for VAS NB by analysing data at all collected timepoints (in participants with VAS-NB ≥ 7 at baseline).
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, 24.
Change from baseline in loss of smell score evaluated by UPSIT or Sniffin Sticks
Change from baseline in loss of smell score evaluated by UPSIT or Sniffin Sticks
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Change from baseline in loss of smell score evaluated by VAS-Taste
Change from baseline in loss of smell score evaluated by VAS-Taste
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Change from baseline in loss of smell score evaluated by VAS-Smell
Change from baseline in loss of smell score evaluated by VAS-Smell
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of UPSIT responders
Proportion of UPSIT responders (MCID from baseline = 4)
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24.
Proportion of Sniffin sticks responders
Proportion of Sniffin sticks responders (MCID from baseline = 6)
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Proportion of VAS-Smell responders
Proportion of VAS-Smell responders (MCID from baseline = -3.0) (in participants with VAS-Smell ≥ 7 at baseline)
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Proportion of participants with a reduction in VAS-Taste score from baseline
Proportion of participants with a reduction in VAS-Taste score from baseline (in participants with VAS-Taste ≥ 7 at baseline)
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Time to first response for UPSIT/Sniffin sticks
Time to first response for UPSIT/Sniffin sticks by analysing data at all collected timepoints.
Time frame: Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24
Time to first response for VAS Smell
Time to first response for VAS Smell by analysing data at all collected timepoints (in participants with VAS-Smell ≥ 7 at baseline).
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Time to first improvement in VAS-Taste
Time to first improvement in VAS-Taste by analysing data at all collected timepoints (in participants with VAS-Taste ≥ 7 at baseline).
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Change from baseline in sleep as evaluated by PSQI total score
Change from baseline in sleep as evaluated by PSQI total score
Time frame: Weeks 0, 12, and 24.
Change from baseline in sleep as evaluated by SNOT-22 Sleep domain score
Change from baseline in sleep as evaluated by SNOT-22 Sleep domain score
Time frame: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
Change from baseline in sleep as evaluated by VAS-Sleep
Change from baseline in sleep as evaluated by VAS-Sleep
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Proportion of PSQI responders
Proportion of PSQI responders (MCID from baseline = - 4.4)
Time frame: Weeks 0, 12, and 24
Proportion of SNOT-22 Sleep domain responders
Proportion of SNOT-22 Sleep domain responders (MCID from baseline = -2.9)
Time frame: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24
Proportion of participants with any improvement in VAS Sleep from baseline
Proportion of participants with any improvement in VAS Sleep from baseline (in participants with VAS-Sleep ≥ 7 at baseline)
Time frame: Daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Time to first response for PSQI
Time to first response for PSQI by analysing data at all collected timepoints.
Time frame: Weeks 0, 12, and 24.
Time to first response for SNOT-22 Sleep domain
Time to first response for SNOT-22 Sleep domain by analysing data at all collected timepoints.
Time frame: Screening, Week 0, Weeks 2, 4, 8, 12, 16, 20, and 24.
Time to first improvement for VAS-Sleep
Time to first improvement for VAS-Sleep by analysing data at all collected timepoints (in participants with VAS-Sleep ≥ 7 at baseline).
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24
Change from baseline in total NPS
Change from baseline in total NPS evaluated by nasal endoscopy.
Time frame: Screening, Weeks 2 and 24
Proportion of NPS responders
Proportion of NPS responders (MCID from baseline = 1.0) at Weeks 2 and 24.
Time frame: Screening, Weeks 2 and 24
Change from baseline in NPQ score
Change from baseline in NPQ score
Time frame: Weeks 0, 8, 12, and 24.
Proportion of NPQ responders
Proportion of NPQ responders (MCID from baseline = 7.0)
Time frame: Weeks 0, 8, 12, and 24
Time to first response for NPQ
Time to first response for NPQ by analysing data collected at each specified timepoint.
Time frame: Weeks 0, 8, 12, and 24.
Change from baseline in TSS
Change from baseline in TSS
Time frame: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Proportion of TSS responders
Proportion of TSS responders (MCID from baseline = 4.0)
Time frame: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Time to first response for TSS
Time to first response for TSS by analysing data at all collected timepoints.
Time frame: daily for the 2 weeks prior to Week 0 and through EOT (Week 24)
Change from baseline in NP severity
Change from baseline in NP severity as measured by VAS Overall symptoms
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of VAS Overall symptom responders
Proportion of VAS Overall symptom responders (MCID from baseline = 2.5)
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Time to first response for VAS-Overall symptom
Time to first response for VAS-Overall symptom by analysing data at all collected timepoints
Time frame: daily for the 2 weeks prior to Week 0 through the first 12 weeks of Treatment Period, and at Weeks 16, 20, and 24.
Proportion of participants who respond as 'well controlled' or 'completely controlled' NP symptoms to the NP control question
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, 20, and 24.
Time to first response for NP control
Time to first response for NP control by analysing data at all collected timepoints.
Time frame: Weeks 0, 4, 8, 12, 20, and 24.