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Efficacy and Safety of Tezepe...

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

NCT ID: NCT04851964

Last Updated: 2025-07-20

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

416 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-22

Study Completion Date

2024-12-11

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Chronic Rhinosinusitis With Nasal Polyps

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Subjects will be randomized in a 1:1 ratio to either tezepelumab or matching placebo both administered subcutaneously.

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Double-Blind

Study Groups

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Tezepelumab

Tezepelumab subcutaneous injection, in an accessorized pre-filled syringe.

Group Type EXPERIMENTAL

Experimental: Tezepelumab

Intervention Type BIOLOGICAL

Tezepelumab subcutaneous injection

Placebo

Placebo subcutaneous injection, in an accessorized pre-filled syringe.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Placebo subcutaneous injection

Interventions

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Experimental: Tezepelumab

Tezepelumab subcutaneous injection

Intervention Type BIOLOGICAL

Placebo

Placebo subcutaneous injection

Intervention Type OTHER

Other Intervention Names

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Tezepelumab

Eligibility Criteria

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Inclusion Criteria

1. Participants with physician-diagnosed CRSwNP for at least 12 months prior to Visit 1 that have:

1. Severity consistent with need for surgery as defined by total NPS ≥ 5 (≥ 2 for each nostril) at screening, as determined by the central reader
2. Nasal Congestion Score (NCS) ≥ 2 at Visit 1
3. Ongoing documented NP symptoms over \> 8 weeks prior to screening such as rhinorrhea and/or reduction/loss of smell
2. SNOT-22 total score ≥ 30 at screening (Visit 1)
3. Any standard of care for treatment of CRSwNP provided the participant is stable on that treatment for 30 days prior to Visit 1
4. 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

1. 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.
2. 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.
3. Positive COVID-19 PCR test (or COVID-19 rapid test) or COVID-19 entry screening questionnaire during the screening visit. Evaluation will be based on on local standard of care as determined by current local guidelines.
4. Regular use of decongestants (topical or systematic) at enrolment is not allowed unless used for endoscopic procedure
5. 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).
6. Receipt of COVID-19 vaccine (regardless of vaccine delivery platform) 28 days prior to date of IP administration at Visit 3 (randomisation visit).

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers