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Asthma drug tested for stubborn nasal polyps – trial cut short

NCT ID NCT04157335

Disease control Sponsor: AstraZeneca Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This phase 3 study tested the drug benralizumab in 295 adults with severe nasal polyps and eosinophilic chronic sinusitis. Participants received injections of benralizumab or a placebo every 4 to 8 weeks for about a year. The goal was to see if the drug could shrink polyps and improve nasal blockage and sense of smell. The trial was terminated early, so the full results are not available.

What this could mean

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

Active substance
Benralizumab (a biologic drug given as an injection)
What this could lead to
If successful, this could point toward a new treatment option for people with severe nasal polyps and chronic sinusitis.
What could go wrong
The trial was terminated early, so results are limited. Benralizumab is already approved for asthma, but its effect on nasal polyps is still uncertain.

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

295 people

The number who actually took part.

Started

Nov 2019

Finished

Apr 2025

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 to 75 years

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. Female or male patients aged 18 to 75 years inclusive 2. Stable Intranasal corticosteroids (INCS) use for at least 4 weeks prior to enrolment and throughout screening and DB period 3. History of treatment with systemic corticosteroids (SCS) or prior surgery for CRSwNP 4. Bilateral sinonasal polyposis with a nasal polyp score (NPS) of 5 at enrolment and randomization (unilateral score of at least 2 for each nostril) 5. Ongoing symptoms for at least 12 weeks prior to enrolment 6. Patient-reported moderate to severe nasal blockage score (NBS) ≥2 at enrolment 7. Bi-weekly mean NBS ≥ 1.5 at randomization 8. SNOT-22 total score ≥ 20 at enrolment and randomization 9. Documented physician-diagnosed asthma 10. Blood eosinophil count of \>2% or ≥150/μL at enrolment 11. LMS E≥M for Asian Exclusion criteria: 1. Any nasal and/or sinus surgery within 3 months prior to enrolment 2. Patients with conditions that makes them non evaluable for the co-primary efficacy endpoint including but not limited to: * Unilateral antrochoanal polyps * Nasal septal deviation that occludes at least one nostril * Current rhinitis medicamentosa * Allergic fungal rhinosinusitis or allergic fungal sinusitis; 3. Clinically important comorbidities (other eosinophil-driven diseases but CRSwNP) that may put the patient at risk, or may confound interpretation of clinical efficacy and/or safety results 4. Receipt of SCS for within 4 weeks prior to screening, or a scheduled SCS treatment during the study period. 5. Receipt of any marketed or investigational biologic product within 6 months of enrolment 6. Currently pregnant or breastfeeding

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Conditions

The condition(s) this trial relates to.

asthma nasal cavity polyp

As listed by the trial registrant

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

Eosinophilic chronic rhinosinusitis Nasal polyposis

Contacts and locations

Locations

  • Research Site

    Huntington Beach, California, 92647, United States

  • Research Site

    Grand Junction, Colorado, 81501, United States

  • Research Site

    Gainesville, Florida, 32605, United States

  • Research Site

    Louisville, Kentucky, 40220, United States

  • Research Site

    White Marsh, Maryland, 21162, United States

  • Research Site

    The Bronx, New York, 10461, United States

  • Research Site

    White Plains, New York, 10605, United States

  • Research Site

    Tulsa, Oklahoma, 74136, United States

  • Research Site

    Bethlehem, Pennsylvania, 18017, United States

  • Research Site

    Fort Worth, Texas, 76109, United States

  • Research Site

    McKinney, Texas, 75070, United States

  • Research Site

    St. George, Utah, 84790, United States

  • Research Site

    Richmond, Virginia, 23235, United States

  • Research Site

    Bellingham, Washington, 98225, United States

  • Research Site

    Milwaukee, Wisconsin, 53228, United States

  • Research Site

    Buenos Aires, C1121 ABE, Argentina

  • Research Site

    Buenos Aires, C1414AIF, Argentina

  • Research Site

    Ciudad de Buenos Aire, C1425BEN, Argentina

  • Research Site

    San Fernando, B1646EBJ, Argentina

  • Research Site

    Herston, 4029, Australia

  • Research Site

    Melbourne, 3004, Australia

  • Research Site

    Spearwood, 6163, Australia

  • Research Site

    Brussels, 1200, Belgium

  • Research Site

    Ghent, 9000, Belgium

  • Research Site

    Leuven, 3000, Belgium

  • Research Site

    Plovdiv, 4001, Bulgaria

  • Research Site

    Sofia, 1303, Bulgaria

  • Research Site

    Sofia, 1606, Bulgaria

  • Research Site

    Quillota, 2260000, Chile

  • Research Site

    Santiago, 7500588, Chile

  • Research Site

    Santiago, 8150000, Chile

  • Research Site

    Talca, 3481349, Chile

  • Research Site

    Beijing, 100044, China

  • Research Site

    Beijing, 100191, China

  • Research Site

    Beijing, 100730, China

  • Research Site

    Changchun, 130061, China

  • Research Site

    Changsha, 410008, China

  • Research Site

    Changsha, 410013, China

  • Research Site

    Changsha, China

  • Research Site

    Chengdu, 610041, China

  • Research Site

    Chengdu, 610072, China

  • Research Site

    Chongqing, 400042, China

  • Research Site

    Foshan, 528000, China

  • Research Site

    Guangzhou, 510000, China

  • Research Site

    Guangzhou, 510180, China

  • Research Site

    Hangzhou, 310003, China

  • Research Site

    Jinan, 250014, China

  • Research Site

    Nanchang, 330006, China

  • Research Site

    Nanjing, 210029, China

  • Research Site

    Nanning, 530021, China

  • Research Site

    Qingdao, 266071, China

  • Research Site

    Shanghai, 200065, China

  • Research Site

    Shanghai, 200092, China

  • Research Site

    Tianjin, 300050, China

  • Research Site

    Ürümqi, 830054, China

  • Research Site

    Wuhan, 430022, China

  • Research Site

    Xi'an, 710004, China

  • Research Site

    Xi'an, 710061, China

  • Research Site

    Yantai, 264000, China

  • Research Site

    Marseille, 13005, France

  • Research Site

    Toulouse, 31059, France

  • Research Site

    Budapest, 1033, Hungary

  • Research Site

    Budapest, 1046, Hungary

  • Research Site

    Győr, 9024, Hungary

  • Research Site

    Kaposvár, 7400, Hungary

  • Research Site

    Siófok, 8600, Hungary

  • Research Site

    Székesfehérvár, 8000, Hungary

  • Research Site

    Tatabánya, 2800, Hungary

  • Research Site

    Catanzaro, 88100, Italy

  • Research Site

    Pisa, 56124, Italy

  • Research Site

    Roma, 00161, Italy

  • Research Site

    Roma, 00168, Italy

  • Research Site

    Chiba, 262-0015, Japan

  • Research Site

    Fujisawa-shi, 251-0052, Japan

  • Research Site

    Hiroshima, 734-8551, Japan

  • Research Site

    Ichikawa-shi, 272-0143, Japan

  • Research Site

    Iida-shi, 395-8505, Japan

  • Research Site

    Kawasaki-shi, 211-0063, Japan

  • Research Site

    Kumamoto, 860-0814, Japan

  • Research Site

    Meguro-ku, 153-0061, Japan

  • Research Site

    Meguro-ku, 153-8515, Japan

  • Research Site

    Minatoku, 105-8471, Japan

  • Research Site

    Moriguchi-shi, 570-0074, Japan

  • Research Site

    Nagaoka-shi, 940-2085, Japan

  • Research Site

    Osaka, 540-0008, Japan

  • Research Site

    Shinjuku-ku, 160-0017, Japan

  • Research Site

    Yoshida-gun, 910-1193, Japan

  • Research Site

    Bydgoszcz, 85-231, Poland

  • Research Site

    Elblag, 82-300, Poland

  • Research Site

    Krakow, 31-513, Poland

  • Research Site

    Lublin, 20-552, Poland

  • Research Site

    Nadarzyn, 05-830, Poland

  • Research Site

    Poznan, 60-805, Poland

  • Research Site

    Wroclaw, 53-301, Poland

  • Research Site

    Łodź, 90-153, Poland

  • Research Site

    Izhevsk, 426061, Russia

  • Research Site

    Penza, 440067, Russia

  • Research Site

    Saint Petersburg, 196158, Russia

  • Research Site

    Taipei, 10002, Taiwan

  • Research Site

    Taipei, 110, Taiwan

  • Research Site

    Taipei, 11217, Taiwan

  • Research Site

    Taipei, 114, Taiwan

  • Research Site

    Taipei, 235, Taiwan

  • Research Site

    Taoyuan, 333, Taiwan

  • Research Site

    Bangkok, 10330, Thailand

  • Research Site

    Bangkok, 10400, Thailand

  • Research Site

    Bangkok, 10700, Thailand

  • Research Site

    Chiang Mai, 50200, Thailand

  • Research Site

    Khon Kaen, 40002, Thailand

  • Research Site

    Phitsanulok, 65000, Thailand

  • Research Site

    Aydin, 09100, Turkey (Türkiye)

  • Research Site

    Bakırköy, 34147, Turkey (Türkiye)

  • Research Site

    Izmir, 35340, Turkey (Türkiye)

  • Research Site

    Malatya, 44280, Turkey (Türkiye)

  • Research Site

    Hanoi, 100000, Vietnam

  • Research Site

    Ho Chi Minh City, 700000, Vietnam

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