New biologic shot could ease severe nasal polyps

NCT ID NCT04851964

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 3 trial tested tezepelumab, a biologic drug given as a shot, in 416 adults with severe chronic sinusitis and nasal polyps. Participants received either tezepelumab or a placebo, plus a standard nasal steroid spray. The study measured changes in polyp size and nasal congestion over 52 weeks. The goal is to see if tezepelumab can improve symptoms and reduce the need for surgery.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: tezepelumab (a biologic drug given as a shot under the skin)
What this could lead to: If it works, this could offer a new treatment option for people with severe nasal polyps who have not responded well to standard therapies, potentially reducing the need for surgery.
What could go wrong: This is a phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects are possible. It is not a cure—ongoing treatment would likely be needed.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

416 people

The number who actually took part.

Started

Apr 2021

Finished

Dec 2024

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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).

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Conditions

The condition(s) this trial relates to.

nasal cavity polyp

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Chronic rhinosinusitis with nasal polyps

Contacts and locations

Locations

Research Site

Birmingham, Alabama, 35209, United States
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Bakersfield, California, 93301, United States
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Newport Beach, California, 92663, United States
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Roseville, California, 95661, United States
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Walnut Creek, California, 94598, United States
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Colorado Springs, Colorado, 80923, United States
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Denver, Colorado, 80230, United States
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Boca Raton, Florida, 33487, United States
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Chicago, Illinois, 60657, United States
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Baltimore, Maryland, 21224, United States
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White Marsh, Maryland, 21162, United States
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Boston, Massachusetts, 02115, United States
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Columbia, Missouri, 65212, United States
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New York, New York, 10003, United States
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Winston-Salem, North Carolina, 27103, United States
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Oklahoma City, Oklahoma, 73120, United States
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North Charleston, South Carolina, 29406, United States
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Dallas, Texas, 75231, United States
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Norfolk, Virginia, 23507, United States
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Spokane, Washington, 99201, United States
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Milwaukee, Wisconsin, 53228, United States
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Vancouver, British Columbia, V6Z 1Y6, Canada
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Hamilton, Ontario, L8S 1G5, Canada
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London, Ontario, N6A 4V2, Canada
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Montreal, Quebec, H2V 2K1, Canada
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Montreal, Quebec, H2X 0A9, Canada
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Montreal, Quebec, H4A 3J1, Canada
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Québec, Quebec, G1S 4L8, Canada
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Québec, Quebec, G1V 4G5, Canada
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Québec, Quebec, G1V 4W2, Canada
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Trois-Rivières, Quebec, G8T 7A1, Canada
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Bengbu, 233004, China
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Chengdu, 610072, China
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Guangzhou, 510120, China
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Hangzhou, 310003, China
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Hangzhou, 310014, China
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Hengyang, 421001, China
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Lanzhou, 730030, China
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Nanchang, 330006, China
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Nanjing, 210009, China
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Qingdao, 266011, China
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Shanghai, 200031, China
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Shanghai, 200433, China
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Suzhou, 215006, China
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Taizhou, 225300, China
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Tianjin, 300121, China
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Tianjin, 300211, China
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Wenzhou, 325027, China
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Wuhan, 430060, China
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Xi'an, 710068, China
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Yinchuan, 750001, China
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Zunyi, 563100, China
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Aalborg, 9000, Denmark
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Aarhus N, 8200, Denmark
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Hillerød, 3400, Denmark
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Hvidovre, 2650, Denmark
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København NV, 2400, Denmark
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Køge, 4600, Denmark
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Odense, 5000, Denmark
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Vejle, 7100, Denmark
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Berlin, 10629, Germany
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Berlin, 13353, Germany
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Dresden, 01307, Germany
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Heidelberg, 69120, Germany
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Lübeck, 23538, Germany
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Marburg, 35043, Germany
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Tübingen, 72076, Germany
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Wiesbaden, 65183, Germany
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Budapest, 1046, Hungary
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Budapest, 1083, Hungary
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Budapest, 1134, Hungary
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Nyíregyháza, 4400, Hungary
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Pécs, 7621, Hungary
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Siófok, 8600, Hungary
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Székesfehérvár, 8000, Hungary
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Bunkyō City, 113-8431, Japan
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Chuo-shi, 409-3898, Japan
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Habikino-shi, 583-0886, Japan
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Ichikawa-shi, 272-0111, Japan
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Itabashi-ku, 173-8610, Japan
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Kashiwa-shi, 277-0882, Japan
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Kisarazu-shi, 292-8535, Japan
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Miyazaki, 880-8510, Japan
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Nagaoka-shi, 940-8621, Japan
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Nerima-ku, 177-0035, Japan
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Niigata, 951-8520, Japan
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Osaka, 553-0003, Japan
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Saitama-shi, 336-8522, Japan
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Sapporo, 003-0022, Japan
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Sendai, 983-8512, Japan
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Suwa-shi, 392-8510, Japan
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Toyonaka Shi, 560-0082, Japan
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Yokohama, 227-8501, Japan
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Yokohama, 236-0037, Japan
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Bialystok, 15-879, Poland
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Bydgoszcz, 85-231, Poland
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Krakow, 31-513, Poland
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Nadarzyn, 05-830, Poland
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Wroclaw, 50-556, Poland
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Wroclaw, 53-301, Poland
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Zawadzkie, 47-120, Poland
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Łodź, 90-153, Poland
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Barakaldo, 48903, Spain
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Barcelona, 08036, Spain
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Jerez de la Frontera, 11407, Spain
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Madrid, 28040, Spain
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Santiago de Compostela, 15706, Spain
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Seville, 41009, Spain
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Dundee, DD1 9SY, United Kingdom
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London, SE1 9RT, United Kingdom
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Manchester, M13 9WL, United Kingdom
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Stockport, SK2 7JE, United Kingdom

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