Efficacy and Safety of Tezepelumab in Participants With Severe Chronic Rhinosinusitis With Nasal Polyposis

  • STATUS
    Recruiting
  • End date
    Jan 9, 2024
  • participants needed
    400
  • sponsor
    AstraZeneca
Updated on 24 July 2021
Investigator
AstraZeneca Clinical Study Information Center
Primary Contact
Research Site (3.5 mi away) Contact
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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

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 Chronic Rhinosinusitis With Nasal Polyps
Treatment Placebo, Experimental: Tezepelumab
Clinical Study IdentifierNCT04851964
SponsorAstraZeneca
Last Modified on24 July 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have
Severity consistent with need for surgery as defined by total NPS 5 ( 2 for each nostril) at screening, as determined by the central reader
Nasal Congestion Score (NCS) 2 at Visit 1
Ongoing documented NP symptoms over > 8 weeks prior to screening such as rhinorrhea and/or reduction/loss of smell
SNOT-22 total score 30 at screening (Visit 1)
Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to Visit 1
Documented treatment of nasal polyposis 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 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
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 rapid test) or COVID-19 entry screening questionnaire during the screening visit. In case of long turnaround time of the nasopharyngeal swab test results from central lab, the site has the following alternatives: Perform COVID-19 nasopharyngeal or oropharyngeal swab test through local lab, Perform a COVID-19 rapid antigen test at the site, provided it is approved by the local health authorities
Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure
Use of immunosuppressive medication (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, mycophenolate, tacrolimus, gold, penicillamine, sulfasalazine, hydroxychloroquine, systemic corticosteroids or any experimental anti-inflammatory therapy) within 3 months prior to Visit 1 and during the study period. Systemic corticosteroid use is defined as treatment with a burst of systemic corticosteroids for at least 3 consecutive days or a single IM depo-injectable dose of corticosteroids (considered equivalent to a 3-day burst of systemic corticosteroids)
Receipt of COVID-19 vaccine (regardless of vaccine delivery platform) 28 days prior to date of IP administration at Visit 3 (randomisation visit)
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