Actively Recruiting
A Study to Investigate Changes in Symptoms in Adult Participants With Chronic Rhinosinusitis With Nasal Polyposis Initiating Treatment With Tezepelumab
Led by AstraZeneca · Updated on 2026-04-20
180
Participants Needed
45
Research Sites
110 weeks
Total Duration
On this page
Sponsors
A
AstraZeneca
Lead Sponsor
F
Fortrea
Collaborating Sponsor
AI-Summary
What this Trial Is About
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).
CONDITIONS
Official 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 CRSwNP for at least 12 months prior to Visit 1.
- Severity requiring surgery with total nasal polyp score (NPS) of 4 or more at screening.
- Mean nasal congestion score (NCS) of 2 or more in the 2 weeks before Visit 2.
- Ongoing nasal polyp symptoms for over 8 weeks before screening, such as runny nose, loss of smell, or poor sleep quality.
- Sino-nasal outcome test (SNOT-22) total score of 30 or higher at screening.
- Stable treatment with intranasal corticosteroids for at least 30 days before Visit 1.
- History of nasal polyp exacerbation treated with systemic corticosteroids or injectable dose within past 12 months but not within last 3 months, or history of nasal polyp surgery.
- Body weight of 40 kg or more at Visit 1.
- Female participants must follow contraceptive guidelines based on childbearing potential and menopausal status.
- Willingness to provide signed informed consent and comply with study requirements.
You will not qualify if you...
- Allergic fungal rhinosinusitis or central compartment atopic disease.
- Significant lung diseases other than asthma that could affect study results.
- Unstable disorders affecting safety or ability to complete study.
- Sinus surgery within 6 months before screening or past surgery altering nasal anatomy making evaluation impossible.
- Conditions affecting primary endpoints such as antrochoanal polyps, nasal septal deviation blocking nostrils, recent infections, or specific syndromes.
- History of cancer except certain skin or cervical cancers treated over 12 months ago, or other malignancies treated over 5 years ago.
- Uncontrolled nosebleeds within 2 months before Visit 1.
- Untreated or unresolved recent helminth infections.
- For those with asthma, current or significant past smokers or recent users of vaping products.
- History of alcohol or drug abuse within 12 months.
- Recent tuberculosis requiring treatment.
- Major surgery within 8 weeks before Visit 1 or planned surgeries during study.
- Known immunodeficiency or positive HIV test.
- Recent infections requiring systemic antibiotics.
- Recent or ongoing significant COVID-19 effects.
- Recent use of biologic or investigational drugs.
- Recent use of systemic immunosuppressive drugs except specific corticosteroids.
- Recent receipt of immunoglobulin or blood products before Visit 1.
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 45 locations
1
Research Site
Newport Beach, California, United States, 92663
Actively Recruiting
2
Research Site
Chicago, Illinois, United States, 60611
Actively Recruiting
3
Research Site
Chestnut Hill, Massachusetts, United States, 02467
Actively Recruiting
4
Research Site
Columbia, Missouri, United States, 65201
Actively Recruiting
5
Research Site
Plovdiv, Bulgaria, 4003
Actively Recruiting
6
Research Site
Sofia, Bulgaria, 1431
Actively Recruiting
7
Research Site
Sofia, Bulgaria, 1606
Withdrawn
8
Research Site
Sofia, Bulgaria, 1606
Actively Recruiting
9
Research Site
Hamilton, Ontario, Canada, L8S 1G5
Actively Recruiting
10
Research Site
Québec, Quebec, Canada, G1L 3L5
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11
Research Site
Québec, Quebec, Canada, G1V 4W2
Actively Recruiting
12
Research Site
Le Kremlin-Bicêtre, France, 94270
Actively Recruiting
13
Research Site
Lille, France, 59000
Withdrawn
14
Research Site
Marseille, France, 13005
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
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
Actively Recruiting
31
Research Site
Naples, Italy, 80131
Withdrawn
32
Research Site
Padua, Italy, 35128
Actively Recruiting
33
Research Site
Pisa, Italy, 56126
Actively Recruiting
34
Research Site
Roma, Italy, 00168
Actively Recruiting
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
Actively Recruiting
44
Research Site
Salamanca, Spain, 37007
Actively Recruiting
45
Research Site
Santiago de Compostela, Spain, 15706
Actively Recruiting
Research Team
A
AstraZeneca Clinical Study Information Center
CONTACT
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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