A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants with Severe Chronic Rhinosinusitis with Nasal Polyposis

  • STATUS
    Recruiting
  • sponsor
    Astra Zeneca
Updated on 12 August 2021

Summary

A Multicentre, Randomised, Double-Blind, Parallel-Group, Placebo-Controlled Phase 3 Efficacy and Safety Study of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis (WAYPOINT)

Description

This is a multicentre, randomised, double-blind, placebo controlled, parallel group study designed to evaluate the efficacy and safety of tezepelumab in adults with severe, chronic rhinosinusitis with nasal polyposis.

Approximately 400 subjects will be randomized globally. Subjects will receive tezepelumab, or placebo, administered via subcutaneous injection using the accessorized pre-filled syringe (APFS), over a 52-week treatment period. The study also includes a post-treatment follow-up period of 12-24 weeks for participants who complete the 52-week treatment period.

Details
Condition Sinus Infections, WAYPOINT, Polyps
Clinical Study IdentifierTX277195
SponsorAstra Zeneca
Last Modified on12 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have
a.) Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader
b.) Nasal Congestion Score (NCS) ≥ 2 at Visit 1
c.) Ongoing documented NP symptoms over > 8 weeks prior to screening such as rhinorrhea and/or reduction/loss of smell
d.) SNOT-22 total score ≥ 30 at screening (Visit 1)
e.) Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to screening visit
f.) Documented treatment with SCS (or contraindications/intolerance to) within the past 12 months and/or any history of NP surgery (or contraindications/intolerance to)

Exclusion Criteria

Any clinically important comorbidities other than asthma (e.g. active lung infection, bronchiectasis, pulmonary fibrosis, cystic fibrosis, primary ciliary dyskinesia, allergic bronchopulmonary mycosis, hypereosinophilic syndromes, etc.) that could confound interpretation of clinical efficacy results
Pre-existing condition which precludes NPS evaluation (nasal septal deviation, antrochoanal polyps, rhinitis medicamentosa, etc)
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
Positive COVID-19 PCR test or COVID-19 entry screening questionnaire during the screening visit
Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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