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A Multicentre, Single-Arm, Phase 3b Study to Assess Changes in Symptoms in Adults With Chronic Rhinosinusitis With Nasal Polyposis Initiating Tezepelumab Treatment
Led by AstraZeneca · Updated on 2026-04-20
180
Participants Needed
45
Research Sites
N/A
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of tezepelumab treatment in adults with chronic rhinosinusitis with nasal polyps (CRSwNP) who have been determined by their physician to be eligible for surgery. This phase IIIb, multicenter, open-label, single-arm study aims to describe changes in nasal congestion and overall sino-nasal symptoms after starting tezepelumab. The study includes participants with or without asthma and focuses on symptom improvements using patient-reported measures. Participants will receive a single dose of tezepelumab via subcutaneous injection every four weeks for up to 24 weeks. The study is organized into three periods: a screening period lasting up to four weeks before treatment begins, a 24-week treatment phase, and a 12-week safety follow-up period after treatment ends. Approximately 60 sites across 10 countries will enroll adults with surgery-eligible CRSwNP. During the study, participants will attend visits every four weeks for assessments, including symptom scores like nasal congestion and sino-nasal outcome tests. Researchers will monitor changes from baseline in these symptoms at multiple time points, along with other measures such as loss of smell, sleep quality, and nasal obstruction. Safety follow-up will continue for 12 weeks after treatment, allowing researchers to evaluate treatment outcomes and participant well-being throughout the study period, which lasts up to 40 weeks in total.
CONDITIONS
Brief Title
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must be 18 years of age or older at the time of signing the informed consent.
- Physician-diagnosed chronic rhinosinusitis with nasal polyps (CRSwNP) for at least 12 months.
- Total nasal polyp score (NPS) of 4 or higher at screening, with at least 2 in each nostril.
- Mean nasal congestion score (NCS) of 2 or higher in the 2 weeks before treatment.
- Ongoing nasal polyp symptoms for more than 8 weeks before screening, such as nasal discharge, reduced or lost sense of smell, and poor sleep quality.
- SNOT-22 total score of 30 or higher at screening.
- Stable use of intranasal corticosteroids for at least 30 days before treatment.
- History of nasal polyp exacerbation treated with systemic corticosteroids or prior nasal polyp surgery, or documented contraindication or intolerance to these treatments.
- Body weight of 40 kg or more at treatment start.
- Women of childbearing potential must use effective contraception during and 16 weeks after treatment.
- Capability to provide signed informed consent and comply with study procedures.
You will not qualify if you...
- Documented allergic fungal rhinosinusitis or central compartment atopic disease.
- Clinically important lung diseases other than asthma that could affect study results.
- Unstable major health conditions that may affect safety or study participation.
- Sinus surgery within 6 months before screening or prior surgery altering nasal anatomy preventing polyp score evaluation.
- Conditions like antrochoanal polyps, nasal septal deviation blocking nostrils, acute infections, or specific syndromes affecting nasal health.
- History of cancer except certain skin or cervical cancers treated over 12 months ago, or other cancers treated over 5 years ago.
- Uncontrolled nosebleeds within 2 months before treatment.
- Recent helminth infection not resolved with treatment.
- Smoking history exceeding 10 pack-years or current smokers among those with asthma.
- History of alcohol or drug abuse within 12 months before treatment.
- Recent tuberculosis, major surgery, or planned surgeries during the study.
- Known immunodeficiency or positive HIV test.
- Recent infections requiring systemic antibiotics.
- Recent COVID-19 infection or significant post-COVID symptoms.
- Recent use of biologic or investigational drugs or systemic immunosuppressants.
- Recent blood product transfusions or immunoglobulin treatment.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - Up to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 24 weeks
Participants receive tezepelumab treatment via subcutaneous injection and are assessed for changes in nasal congestion and sino-nasal symptoms.
Visits at Weeks 0, 1, 2, 4, 8, 12, 16, 20, and 24 with additional daily assessments in the 2 weeks prior to Week 0 through Week 12, and assessments at Weeks 16, 20, and 24
Duration - 12 weeks
Participants are monitored for safety after completing treatment.
Visits from Week 24 to Week 36
Trial Site Locations
Total: 45 locations
1
Research Site
Newport Beach, California, United States, 92663
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2
Research Site
Chicago, Illinois, United States, 60611
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3
Research Site
Chestnut Hill, Massachusetts, United States, 02467
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4
Research Site
Columbia, Missouri, United States, 65201
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5
Research Site
Plovdiv, Bulgaria, 4003
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6
Research Site
Sofia, Bulgaria, 1431
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7
Research Site
Sofia, Bulgaria, 1606
Withdrawn
8
Research Site
Sofia, Bulgaria, 1606
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9
Research Site
Hamilton, Ontario, Canada, L8S 1G5
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10
Research Site
Québec, Quebec, Canada, G1L 3L5
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11
Research Site
Québec, Quebec, Canada, G1V 4W2
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12
Research Site
Le Kremlin-Bicêtre, France, 94270
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13
Research Site
Lille, France, 59000
Withdrawn
14
Research Site
Marseille, France, 13005
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15
Research Site
Nantes, France, 44093
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16
Research Site
Pierre-Bénite, France, 69495
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17
Research Site
Poitiers, France, 86000
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18
Research Site
Toulouse, France, 31400
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19
Research Site
Düsseldorf, Germany, 40225
Withdrawn
20
Research Site
Marburg, Germany, 35043
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21
Research Site
Tübingen, Germany, 72076
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22
Research Site
Villingen-Schwenningen, Germany, 78052
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23
Research Site
Wiesbaden, Germany, 65183
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24
Research Site
Budapest, Hungary, 1085
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25
Research Site
Budapest, Hungary, 1134
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26
Research Site
Nyíregyháza, Hungary, 4400
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27
Research Site
Pécs, Hungary, 7621
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28
Research Site
Bologna, Italy, 40139
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29
Research Site
Catania, Italy, 95123
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30
Research Site
Florence, Italy, 50139
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31
Research Site
Naples, Italy, 80131
Withdrawn
32
Research Site
Padua, Italy, 35128
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33
Research Site
Pisa, Italy, 56126
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34
Research Site
Roma, Italy, 00168
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35
Research Site
Rozzano, Italy, 20089
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36
Research Site
Bialystok, Poland, 15-879
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37
Research Site
Bydgoszcz, Poland, 85-231
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38
Research Site
Lodz, Poland, 90-302
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39
Research Site
Zawadzkie, Poland, 47-120
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40
Research Site
Barcelona, Spain, 08003
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41
Research Site
Barcelona, Spain, 08035
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42
Research Site
Cadiz, Spain, 11011
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43
Research Site
Madrid, Spain, 28041
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44
Research Site
Salamanca, Spain, 37007
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45
Research Site
Santiago de Compostela, Spain, 15706
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Research Team
A
AstraZeneca Clinical Study Information Center
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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