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New injection could shrink nasal polyps without surgery

NCT ID NCT05274750

Disease control Sponsor: GlaxoSmithKline 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 This study
The trial has finished. Results may not be published yet.
Stopped early
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This status has not been confirmed recently, so it may be out of date.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 trial tested a biologic drug called depemokimab in 276 adults with chronic sinusitis and nasal polyps. Participants received either the drug or a placebo as an injection under the skin. The study measured changes in polyp size and nasal blockage over 52 weeks to see if the drug can improve symptoms and reduce the need for surgery or steroids.

What this could mean

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

Active substance
Depemokimab (a biologic drug given as an injection under the skin)
What this could lead to
If it works, this could offer a new treatment option to reduce nasal polyps and improve breathing without needing surgery or steroids.
What could go wrong
This is a single phase 3 trial with 276 participants, so results may not apply to everyone. The drug may cause side effects like injection reactions or infections.

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

276 people

The number who actually took part.

Started

Apr 2022

Finished

Aug 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: * Participants with 18 years of age and older inclusive, at the time of signing the informed consent. * Endoscopic bilateral NP score of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity) assessed by the investigator. * Participants who have had at least one of the following at Visit 1: Previous nasal surgery for the removal of NP; have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of NP; medically unsuitable or intolerant to systemic corticosteroid. * Participants (except for those in Japan) must be on daily treatment with intranasal corticosteroids (INCS) (including intranasal liquid steroid wash/douching) for at least the 8 weeks immediately prior to screening. * Participants presenting with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhea (runny nose) based on clinical assessment by the investigator. * Presence of symptoms of chronic rhinosinusitis as described by at least 2 different symptoms for at least 12 weeks prior to Visit 1, one of which should be either nasal blockage/obstruction/congestion or nasal discharge (anterior/posterior nasal drip), plus facial pain/pressure and/or reduction or loss of smell. * Male or eligible female participants. Exclusion criteria: Exclusion criteria: * As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study. * Cystic fibrosis. * Antrochoanal polyps. * Nasal cavity tumor (malignant or benign). * Fungal rhinosinusitis. * Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils * Participants who had a sino-nasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of nasal polyp score. * Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening. * Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis). * Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of screening. * Participants who have undergone any intranasal and/or sinus surgery (for example \[e.g.\], polypectomy, balloon dilatation or nasal stent insertion) within 6 months prior to Visit 1; nasal biopsy prior to Visit 1 for diagnostic purposes only is excepted. * Participants where NP surgery is contraindicated in the opinion of the Investigator. * Participants with other conditions that could lead to elevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) Eosinophilic granulomatosis with polyangiitis (EGPA) (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis. * Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1. * A known immunodeficiency (e.g. human immunodeficiency virus \[HIV\]), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma. * A current malignancy or previous history of cancer in remission for less than 12 months prior to screening. * Liver Disease: Alanine aminotransferase (ALT) \>2 times Upper limit of normal (ULN); Total bilirubin \>1.5 times ULN (isolated bilirubin \>1.5 times ULN is acceptable if bilirubin is fractionated and direct bilirubin less than \[\<\]35 percent \[%\]); Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminemia, esophageal or gastric varices, persistent jaundice. * Participants who have known, pre-existing, clinically significant cardiac, endocrine, autoimmune, metabolic, neurological, renal, gastrointestinal, hepatic, hematological or any other system abnormalities that are uncontrolled with standard treatment. * Participants with current diagnosis of vasculitis. Participants with high clinical suspicion of vasculitis at screening will be evaluated and current vasculitis must be excluded prior to enrollment. * Hypersensitivity: Participants with allergy/intolerance to the excipients of depemokimab (GSK3511294) in a monoclonal antibody, or biologic. * Participants that, according to the investigator's medical judgment, are likely to have active Coronavirus Disease-2019 (COVID-19) infection must be excluded. Participants with known COVID-19 positive contacts within the past 14 days must be excluded for at least 14 days following the exposure during which the participant should remain symptom-free. Reported smell/ taste complications from COVID-19 must be used as exclusion. * Participants that have been exposed to ionizing radiation in excess of 10 millisievert (mSv) above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies. * Previously participated in any study with mepolizumab, reslizumab, or benralizumab and received study intervention (including placebo) within 12 months prior to Visit 1. * Women who are pregnant or lactating or are planning on becoming pregnant during the study.

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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.

Nasal polyps

Contacts and locations

Locations

  • GSK Investigational Site

    Tucson, Arizona, 85704, United States

  • GSK Investigational Site

    Buena Park, California, 90621, United States

  • GSK Investigational Site

    Los Angeles, California, 90006, United States

  • GSK Investigational Site

    San Diego, California, 91942, United States

  • GSK Investigational Site

    Stanford, California, 94304, United States

  • GSK Investigational Site

    Temecula, California, 92592, United States

  • GSK Investigational Site

    Aurora, Colorado, 80045, United States

  • GSK Investigational Site

    Gainesville, Florida, 32605, United States

  • GSK Investigational Site

    Tamarac, Florida, 33321, United States

  • GSK Investigational Site

    Tampa, Florida, 33613, United States

  • GSK Investigational Site

    Meridian, Idaho, 83642, United States

  • GSK Investigational Site

    Meridian, Idaho, 83706, United States

  • GSK Investigational Site

    Chicago, Illinois, 60612, United States

  • GSK Investigational Site

    Lexington, Kentucky, 40509, United States

  • GSK Investigational Site

    Louisville, Kentucky, 40205, United States

  • GSK Investigational Site

    Boston, Massachusetts, 02135, United States

  • GSK Investigational Site

    New Brunswick, New Jersey, 08901, United States

  • GSK Investigational Site

    Great Neck, New York, 11021, United States

  • GSK Investigational Site

    Rochester, New York, 14642, United States

  • GSK Investigational Site

    Chapel Hill, North Carolina, 27599, United States

  • GSK Investigational Site

    Cincinnati, Ohio, 45267, United States

  • GSK Investigational Site

    Tulsa, Oklahoma, 74137, United States

  • GSK Investigational Site

    Bethlehem, Pennsylvania, 18017, United States

  • GSK Investigational Site

    Providence, Rhode Island, 02914, United States

  • GSK Investigational Site

    Dallas, Texas, 75390-9035, United States

  • GSK Investigational Site

    Richmond, Virginia, 23235, United States

  • GSK Investigational Site

    Buenos Aires, 1023, Argentina

  • GSK Investigational Site

    Buenos Aires, C1425BEN, Argentina

  • GSK Investigational Site

    Buenos Aires, C1426ABP, Argentina

  • GSK Investigational Site

    Ciudad Autonoma de Bueno, C1121ABE, Argentina

  • GSK Investigational Site

    Florida, B1602DOH, Argentina

  • GSK Investigational Site

    La Plata, 1900, Argentina

  • GSK Investigational Site

    Mar del Plata, 7600, Argentina

  • GSK Investigational Site

    Mendoza, 5500, Argentina

  • GSK Investigational Site

    Mendoza, M5500CCG, Argentina

  • GSK Investigational Site

    Rosario, S2000DBS, Argentina

  • GSK Investigational Site

    Ghent, 9000, Belgium

  • GSK Investigational Site

    Hamilton, Ontario, L8L 2X2, Canada

  • GSK Investigational Site

    London, Ontario, N6A 4V2, Canada

  • GSK Investigational Site

    Ottawa, Ontario, K1H 1E4, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2V 2K1, Canada

  • GSK Investigational Site

    Montreal, Quebec, H2X 3E4, Canada

  • GSK Investigational Site

    Québec, Quebec, G1S 4L8, Canada

  • GSK Investigational Site

    Québec, Quebec, G1V 4W2, Canada

  • GSK Investigational Site

    Beijing, 100191, China

  • GSK Investigational Site

    Beijing, 100730, China

  • GSK Investigational Site

    Dongguan, 523326, China

  • GSK Investigational Site

    Jingzhou, 434020, China

  • GSK Investigational Site

    Nanchang, 330006, China

  • GSK Investigational Site

    Qingdao, 266061, China

  • GSK Investigational Site

    Shanghai, 200065, China

  • GSK Investigational Site

    Taiyuan, 300201, China

  • GSK Investigational Site

    Wenzhou, 325000, China

  • GSK Investigational Site

    Wuhan, 430022, China

  • GSK Investigational Site

    Yantai, 264000, China

  • GSK Investigational Site

    Clermont-Ferrand, 63003, France

  • GSK Investigational Site

    Créteil, 94010, France

  • GSK Investigational Site

    Grenoble, 38043, France

  • GSK Investigational Site

    La Roche-sur-Yon, 85925, France

  • GSK Investigational Site

    La Rochelle, 17019, France

  • GSK Investigational Site

    Marseille, 13005, France

  • GSK Investigational Site

    Montpellier, 34295, France

  • GSK Investigational Site

    Nantes, 44093, France

  • GSK Investigational Site

    Pontoise, 95300, France

  • GSK Investigational Site

    Toulouse, 31059, France

  • GSK Investigational Site

    Valenciennes, 59322, France

  • GSK Investigational Site

    Bonn, 53127, Germany

  • GSK Investigational Site

    Dortmund, 44137, Germany

  • GSK Investigational Site

    Dresden, 01139, Germany

  • GSK Investigational Site

    Dresden, 01307, Germany

  • GSK Investigational Site

    Düsseldorf, 40225, Germany

  • GSK Investigational Site

    Düsseldorf, 40549, Germany

  • GSK Investigational Site

    Marburg, 35043, Germany

  • GSK Investigational Site

    München, 81377, Germany

  • GSK Investigational Site

    Münster, 48149, Germany

  • GSK Investigational Site

    Wiesbaden, 65183, Germany

  • GSK Investigational Site

    Ehime, 790-0024, Japan

  • GSK Investigational Site

    Ehime, 798-8510, Japan

  • GSK Investigational Site

    Fukui, 910-1193, Japan

  • GSK Investigational Site

    Fukuoka, 806-8501, Japan

  • GSK Investigational Site

    Ishikawa, 920-0293, Japan

  • GSK Investigational Site

    Kanagawa, 231-8682, Japan

  • GSK Investigational Site

    Kanagawa, 250-8558, Japan

  • GSK Investigational Site

    Kumamoto, 860-0814, Japan

  • GSK Investigational Site

    Kyoto, 600-8216, Japan

  • GSK Investigational Site

    Mie, 514-8507, Japan

  • GSK Investigational Site

    Nagano, 392-8510, Japan

  • GSK Investigational Site

    Osaka, 560-0082, Japan

  • GSK Investigational Site

    Osaka, 570-8507, Japan

  • GSK Investigational Site

    Tokyo, 160-0023, Japan

  • GSK Investigational Site

    Tokyo, 173-0026, Japan

  • GSK Investigational Site

    Amsterdam, 1105 AZ, Netherlands

  • GSK Investigational Site

    Leiden, 2353 GA, Netherlands

  • GSK Investigational Site

    Barcelona, 08022, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Jerez de la Frontera, 11407, Spain

  • GSK Investigational Site

    Madrid, 28034, Spain

  • GSK Investigational Site

    Madrid, 28040, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Seville, 41009, Spain

  • GSK Investigational Site

    Valladolid, 47005, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Great Yarmouth, NR31 6LA, United Kingdom

  • GSK Investigational Site

    Stevenage, SG1 4AB, United Kingdom

  • GSK Investigational Site

    Wigan, WN1 2NN, United Kingdom

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