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Active, not recruitingNCT06706817ESSENCEUpdated Oct 7, 2026

A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab

A Phase 3 interventional study of Tezepelumab in Chronic Rhinosinusitis With Nasal Polyps, sponsored by AstraZeneca. Active, not recruiting at 41 sites in 9 countries. Open to participants aged 18 Years to 130 Years. Per ClinicalTrials.gov, last updated 2026-10-07.

Sponsored by AstraZeneca · Phase 3, Interventional, and Treatment

Phase
Phase 3
Study type
Interventional
Enrollment
181
Allocation
Not applicable
Ages
18 Years to 130 Years
Sex
All
01

Study summary

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).
Read the detailed description

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)
02

Conditions studied

  • Chronic Rhinosinusitis With Nasal Polyps

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Keywords

  • Chronic rhinosinusitis
  • Rhinosinusitis
03

In context

Rhinosinusitis

330 studies on the registry are indexed under Rhinosinusitis; 55 are open to participants now.

This study's enrollment of 181 is above the median of 60 across 227 interventional studies indexed under Rhinosinusitis.

Browse Rhinosinusitis studies →

Lead sponsor

AstraZeneca is the lead sponsor of 3,429 studies on the registry; 270 are open to participants now.

Of its 358 completed or terminated interventional studies of FDA-regulated products, 173 (48%) have results posted.

Browse AstraZeneca studies →

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 130 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • Participants must be 18 years of age or older, at the time of signing the informed consent.
  • Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 who have all of the following:
  • 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
  • SNOT-22 total score ≥ 30 as assessed at screening. Note: approximately 50 participants with a NPS = 4 at screening will receive treatment with tezepelumab.
  • Any standard of care for treatment of CRSwNP, which must include treatment with intranasal corticosteroids, provided the participant is stable on that treatment for at least 30 days prior to Visit 1. Investigators should also assure that participants are compliant and on a stable dose of the background INCS during study period.
  • Either 1) documented treatment of NP exacerbation with SCS for at least 3 consecutive days or one IM depo-injectable dose (or contraindications/intolerance to) within the past 12 months prior to Visit 1 but not within the last 3 months prior to Visit 1 OR 2) any history of NP surgery (or contraindications/intolerance to)
  • Body weight of ≥ 40 kg at Visit 1
  • Female participants:
  • Contraceptive use by women should be consistent with local regulations regarding the methods of contraception for those participating in clinical studies. Women of non childbearing potential are defined as women who are either permanently sterilised (hysterectomy, bilateral oophorectomy, or bilateral salpingectomy), or who are postmenopausal.
  • Women will be considered postmenopausal if they have been amenorrhoeic for 12 months prior to the planned start date of the first IMP administration without an alternative medical cause.

The following age-specific requirements apply:

  • Women \< 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of exogenous hormonal treatment and FSH levels in the postmenopausal range.
  • Women ≥ 50 years old would be considered postmenopausal if they have been amenorrhoeic for 12 months or more following cessation of all exogenous hormonal treatment.
  • WOCBP must be willing to use one of the methods of contraception described hereafter, from the time of signing the ICF throughout the study and 16 weeks after last tezepelumab administration:
  • Combined (oestrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: oral, intravaginal, transdermal
  • Progestogen-only hormonal contraception associated with inhibition of ovulation: oral, injectable, implantable
  • Intrauterine device
  • Intrauterine hormone-releasing system
  • Bilateral tubal occlusion
  • Vasectomised partner (vasectomised partner is a highly effective birth control method provided that the partner is the sole sexual partner of the WOCBP participant and that the vasectomised partner has received medical assessment of the surgical success)
  • Sexual abstinence: it is considered a highly effective method only if defined as refraining from heterosexual intercourse during the entire period of risk associated with the study treatments. The reliability of sexual abstinence needs to be evaluated in relation to the duration of the study and the preferred and usual lifestyle of the participant.
  • Cessation of contraception after this point should be discussed with a responsible physician.
  • Provision of signed and dated written ICF as described in Appendix A 3 prior to any mandatory study-specific procedures, sampling, and analyses.
  • Participant who is capable of giving signed informed consent as described in Appendix A 3 which includes compliance with the requirements and restrictions listed in the ICF and in this protocol.

Exclusion criteria

Exclusion Criteria:

  • 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.

  • Any disorder, including, but not limited to, cardiovascular, gastrointestinal, hepatic, renal, neurological, musculoskeletal, infectious, endocrine, metabolic, haematological, psychiatric, or major physical impairment that is not stable in the opinion of the investigator and could:

    • Affect the safety of the participant throughout the study
    • Influence the findings of the study or the interpretation
    • Impede the participant's ability to complete the entire duration of study.
  • Sinus surgery within 6 months of screening visit OR any sinus surgery in the past which changed the lateral wall of the nose making NPS evaluation impossible.
  • Participants with conditions or concomitant disease that makes them non-evaluable for the primary CRSwNP endpoints such as:
  • Antrochoanal polyps
  • Nasal septal deviation that occludes at least one nostril
  • Acute sinusitis, nasal infection, asthma exacerbation or upper respiratory infection at screening or in the two weeks before screening, or Churg-Strauss syndrome (also known as eosinophilic granulomatosis with polyangiitis), Young's syndrome or Kartagener's syndrome

  • History of cancer:

    1. Participants who have had basal cell carcinoma, localised squamous cell carcinoma of the skin or in situ carcinoma of the cervix are eligible to participate in the study provided that curative therapy was completed at least 12 months prior to Visit 1.
    2. Participants who have had other malignancies are eligible provided that curative therapy was completed at least 5 years prior to Visit 1.
  • Uncontrolled epistaxis within 2 months of Visit 1
  • A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy.
  • For participants with comorbid asthma: Current smokers or participants with a smoking history ≥ 10 packs per year and participants using vaping products, including electronic cigarettes. Former smokers with a smoking history of \< 10 pack per year and users of vaping or e-cigarette products must have stopped for at least 6 months prior to Visit 1 to be eligible.
  • History of chronic alcohol or drug abuse within 12 months prior to Visit 1.
  • Tuberculosis requiring treatment within the 12 months prior to Visit 1.
  • Major surgery within 8 weeks prior to Visit 1 or planned NP surgery or planned surgical procedures requiring general anaesthesia or inpatient status for more than 1 day during the conduct of the study.
  • History of known immunodeficiency disorder including a positive HIV test at Visit 1, or the participant taking antiretroviral medications as determined by medical history and/or participant's verbal report.
  • Infection requiring systemic antibiotics within 14 days prior to Visit 1. Note: Participants with respiratory infections requiring antibiotics within 14 days prior to Visit 1 may extend their screening period to allow recovery and return no sooner than 14 days after completion of therapy.
  • Evidence of COVID-19 within 4 weeks prior to screening or ongoing clinically significant COVID-19 sequelae (eg, participants who have long-term post-COVID-19 anosmia).
  • Receipt of any marketed or investigational biologic agent within 4 months or 5 half-lives (whichever is longer) prior to Visit 1 or receipt of any investigational non-biologic agent within 30 days or 5 half-lives (whichever is longest) prior to Visit 1.
  • Treatment with systemic immunosuppressive/immunomodulating drugs (eg, methotrexate, cyclosporine, etc.), except for SCS used in the treatment of asthma/asthma exacerbations, within the last 12 weeks or 5 half-lives (whichever is longer) prior to Visit 1.
  • Receipt of immunoglobulin or blood products within 30 days prior to Visit 1.
05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
181 participants (actual)

Study arms

  • Experimental
    Tezepelumab

    Tezepelumab: Tezepelumab single dose subcutaneously injection.

    Combination Product: Tezepelumab

Interventions

  • Combination productTezepelumab

    IMP. Subcutaneous injection. Unit dose strengths 210 mg.

    Also known as: TEZSPIRE®

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

Secondary outcomes

  1. 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

  2. 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

  3. 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).

  4. 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.

  5. Time to first response for SNOT-22

    Description of time to first response for SNOT-22 by analysing data at all collected timepoints.

    Time frame: Screening, Weeks 0, 2, 4, 8, 12, 16, 20, and 24.

  6. 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.

  7. 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.

  8. 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.

  9. Proportion of PNIF responders

    Proportion of PNIF responders (MCID from baseline =20 L/min).

    Time frame: Weeks 0, 4, 12, and 24.

  10. 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.

  11. 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

  12. 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.

  13. 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

  14. 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

  15. 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.

  16. 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.

  17. 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

  18. 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

  19. 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.

  20. 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

  21. 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

  22. 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.

  23. 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.

  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

  25. 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

  26. Proportion of PSQI responders

    Proportion of PSQI responders (MCID from baseline = - 4.4)

    Time frame: Weeks 0, 12, and 24

  27. 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

  28. 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

  29. 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.

  30. 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.

  31. 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

  32. Change from baseline in total NPS

    Change from baseline in total NPS evaluated by nasal endoscopy.

    Time frame: Screening, Weeks 2 and 24

  33. 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

  34. Change from baseline in NPQ score

    Change from baseline in NPQ score

    Time frame: Weeks 0, 8, 12, and 24.

  35. Proportion of NPQ responders

    Proportion of NPQ responders (MCID from baseline = 7.0)

    Time frame: Weeks 0, 8, 12, and 24

  36. 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.

  37. 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)

  38. 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)

  39. 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)

  40. 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.

  41. 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.

  42. 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.

  43. 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.

  44. 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.

Other outcomes

  1. Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization

    Endoscopy findings will be used to describe histological changes and describe CRSwNP visualization from baseline to Week 24.

    Time frame: Screening, Weeks 2 and 24

  2. Change from baseline in blood eosinophil count (BEC), total serum IgE, specific IgE (including fungi/moulds [eg, Alternaria]), S. aureus enterotoxin IgE, and Fractional exhaled nitric oxide (FeNO; for asthma participants only)

    Change from baseline in blood eosinophil count (BEC), total serum IgE, specific IgE (including fungi/moulds \[eg, Alternaria\]), S. aureus enterotoxin IgE, and Fractional exhaled nitric oxide (FeNO; for asthma participants only)

    Time frame: Screening (for BEC and FeNO), Week 0 (for IgE and S. aureus enterotoxin IgE), Weeks 12 and 24

  3. Change from baseline in WPAI-CRSwNP

    Change from baseline in WPAI-CRSwNP

    Time frame: Week 0 and Week 24

  4. Proportion and annualised rate of primary care visits (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of primary care visits (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre-and post index (index = 1st tezepelumab dosing).

  5. Change in incident rate of nasal infection comparing the post-index period versus the pre-index period

    Change in incident rate of nasal infection comparing the post-index period versus the pre-index period (index = 1st tezepelumab dosing).

    Time frame: 24 weeks pre- and post-index. (index = 1st tezepelumab dosing)

  6. Change in proportion of participants with CRSwNP-related SCS use during the post-index period (24 weeks following tezepelumab first dose) versus the pre-treatment period (24 weeks prior to tezepelumab first dose)

    Change in proportion of participants with CRSwNP-related SCS use during the post-index period (24 weeks following tezepelumab first dose) versus the pre-treatment period (24 weeks prior to tezepelumab first dose)

    Time frame: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

  7. Change in average SCS daily dose during the post-index period versus dose at/closest to the index

    Change in average SCS daily dose during the post-index period (24 weeks following tezepelumab first dose) versus dose at/closest to the index

    Time frame: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

  8. Proportion of participants with the decision for CRSwNP surgery during the 24 weeks pre- and post-index and change in NP surgery proportion following tezepelumab initiation.

    Proportion of participants with the decision for CRSwNP surgery during the 24 weeks pre- and post-index and change in NP surgery proportion following tezepelumab initiation.

    Time frame: 24-weeks pre- and post- index. (index = 1st tezepelumab dosing).

  9. Proportion of patients with CRSwNP exacerbation

    Proportion of patients with CRSwNP exacerbation

    Time frame: 24-weeks pre- and post-index (index = 1st tezepelumab dosing).

  10. Change since baseline in Asthma Control Questionnaire 6 (ACQ-6) score

    Change since baseline in Asthma Control Questionnaire 6 (ACQ-6) score

    Time frame: Weeks 0 and 24.

  11. ACQ-6 responder: proportion of participants with change since baseline in ACQ-6 of 0.5 or above

    ACQ-6 responder: proportion of participants with change since baseline in ACQ-6 of 0.5 or above

    Time frame: Weeks 0 and 24

  12. Annualised asthma exacerbation rate

    Annualised asthma exacerbation rate

    Time frame: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

  13. Change from baseline in Annualised asthma exacerbation rate

    Change from baseline in Annualised asthma exacerbation rate

    Time frame: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

  14. Lung function (Forced expiratory volume in 1 second [FEV1]) (if available at site)

    Lung function (Forced expiratory volume in 1 second \[FEV1\]) (if available at site)

    Time frame: Weeks 0, 12 (lung function only) and 24.

  15. Asthma-related SCS use (yes/no)

    Asthma-related SCS use (yes/no)

    Time frame: 24 weeks pre-and post-index (index = 1st tezepelumab dosing).

  16. Proportion and annualised rate of urgent care (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of urgent care (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre-and post index (index=1st tezepelumab dosing)

  17. Proportion and annualised rate of unplanned surgery (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of unplanned surgery (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre and post index (index=ist tezepelumab dosing)

  18. Proportion and annualised rate of unplanned out participant visits (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of unplanned out participant visits (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre- and post index (index=1st tezepelumab dosing)

  19. Proportion and annualised rate of emergency room visits (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of emergency room visits (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre-and post index (index=1st tezepelumab dosing)

  20. Proportion and annualised rate of hospitalisations (all rates for CRSwNP-related and asthma-related).

    Proportion and annualised rate of hospitalisations (all rates for CRSwNP-related and asthma-related).

    Time frame: 24 weeks pre-and post index(index=1st tezepelumab dosing)

  21. Asthma related SCS use as part of an exacerbation

    Asthma related SCS use as part of an exacerbation

    Time frame: 24 weeks pre-and post index(index=1st tezepelumab dosing)

  22. Asthma related SCS duration of use

    Asthma related SCS duration of use

    Time frame: 24 weeks pre-and post index(index=1st tezepelumab dosing)

  23. Asthma related SCS daily dose

    Asthma related SCS daily dose

    Time frame: 24 weeks pre-and post index(index=1st tezepelumab dosing)

07

Study locations

41 sites
  • Research Site
    Newport Beach, California 92663, United States
  • Research Site
    Chicago, Illinois 60611, United States
  • Research Site
    Chestnut Hill, Massachusetts 02467, United States
  • Research Site
    Columbia, Missouri 65201, United States
  • Research Site
    Plovdiv, 4003, Bulgaria
  • Research Site
    Sofia, 1431, Bulgaria
  • Research Site
    Sofia, 1606, Bulgaria
  • Research Site
    Hamilton, Ontario L8S 1G5, Canada
  • Research Site
    Québec, Quebec G1L 3L5, Canada
  • Research Site
    Québec, Quebec G1V 4W2, Canada
  • Research Site
    Le Kremlin-Bicêtre, 94270, France
  • Research Site
    Marseille, 13005, France
  • Research Site
    Nantes, 44093, France
  • Research Site
    Pierre-Bénite, 69495, France
  • Research Site
    Poitiers, 86000, France
  • Research Site
    Toulouse, 31400, France
  • Research Site
    Marburg, 35043, Germany
  • Research Site
    Tübingen, 72076, Germany
  • Research Site
    Villingen-Schwenningen, 78052, Germany
  • Research Site
    Wiesbaden, 65183, Germany
  • Research Site
    Budapest, 1085, Hungary
  • Research Site
    Budapest, 1134, Hungary
  • Research Site
    Nyíregyháza, 4400, Hungary
  • Research Site
    Pécs, 7621, Hungary
  • Research Site
    Bologna, 40139, Italy
  • Research Site
    Catania, 95123, Italy
  • Research Site
    Florence, 50139, Italy
  • Research Site
    Padua, 35128, Italy
  • Research Site
    Pisa, 56126, Italy
  • Research Site
    Roma, 00168, Italy
  • Research Site
    Rozzano, 20089, Italy
  • Research Site
    Bialystok, 15-879, Poland
  • Research Site
    Bydgoszcz, 85-231, Poland
  • Research Site
    Lodz, 90-302, Poland
  • Research Site
    Zawadzkie, 47-120, Poland
  • Research Site
    Barcelona, 08003, Spain
  • Research Site
    Barcelona, 08035, Spain
  • Research Site
    Cadiz, 11011, Spain
  • Research Site
    Madrid, 28041, Spain
  • Research Site
    Salamanca, 37007, Spain
  • Research Site
    Santiago de Compostela, 15706, Spain
08

References and documents

Individual participant data

Plan to share: Yes — Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal Vivli.org. All requests will be evaluated as per the AZ disclosure commitment: https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure. "Yes", indicates that AZ are accepting requests for IPD, but this does not mean all requests will be approved.

Supporting information: Study protocol, Sap

No publications or documents are linked to this record.

09

Updates

1 registry update since Sep 25, 2026
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 7, 2026
Show all 1 update
  1. Oct 7, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT06706817
Lead sponsor
AstraZeneca
Collaborators
Fortrea
Responsible party
Sponsor
First posted
Nov 27, 2024
Start date
Dec 3, 2024
Primary completion
Jan 13, 2027 (estimated)
Completion
Jan 13, 2027 (estimated)
Last update
Oct 7, 2026

Study contacts

Tanya M Laidlaw, MD
principal investigator · Director of Translational Research in Allergy and Director of the Aspirin-Exacerbated Respiratory Disease (AERD) Centre at the Brigham and Women's Hospital.
Enrico Heffler, MD, PhD
principal investigator · Associate Professor of Internal Medicine and Consultant at the Personalized Medicine, Asthma and Allergy Unit at IRCCS Humanitas Research Hospital

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is active, not recruiting, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.

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