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New shot could shrink nasal polyps without surgery

NCT ID NCT05281523

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 26, 2026 · Last updated Jun 26, 2026

Summary

This Phase 3 trial tested a biologic drug called depemokimab in 264 adults with chronic sinusitis and nasal polyps. Participants received either the drug or a placebo as a shot under the skin. The study measured changes in polyp size and nasal blockage over 52 weeks. The goal is to see if depemokimab can reduce symptoms and 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 a shot under the skin)
What this could lead to
If it works, this could offer a new treatment option to shrink nasal polyps and ease breathing without needing surgery or steroids.
What could go wrong
This is a completed Phase 3 trial, but results are not yet published. The drug may not work better than placebo, and side effects like allergic reactions or infections are possible.

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

264 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: 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 8 weeks 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 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 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 ionising 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, 85724, United States

  • GSK Investigational Site

    Roseville, California, 95661, United States

  • GSK Investigational Site

    New Haven, Connecticut, 06520, United States

  • GSK Investigational Site

    Hialeah, Florida, 33012, United States

  • GSK Investigational Site

    Baltimore, Maryland, 21287, United States

  • GSK Investigational Site

    Grand Rapids, Michigan, 55446, United States

  • GSK Investigational Site

    Columbia, Missouri, 65212, United States

  • GSK Investigational Site

    Oklahoma City, Oklahoma, 73120, United States

  • GSK Investigational Site

    Fort Worth, Texas, 76109, United States

  • GSK Investigational Site

    McAllen, Texas, 78503, United States

  • GSK Investigational Site

    McKinney, Texas, 75070, United States

  • GSK Investigational Site

    San Antonio, Texas, 78258, United States

  • GSK Investigational Site

    Norfolk, Virginia, 23507, United States

  • GSK Investigational Site

    Morgantown, West Virginia, 26506-9200, United States

  • GSK Investigational Site

    Changsha, 410013, China

  • GSK Investigational Site

    Chengdu, 610041, China

  • GSK Investigational Site

    Guangzhou, 510000, China

  • GSK Investigational Site

    Hangzhou, 310000, China

  • GSK Investigational Site

    Nanjing, 210009, China

  • GSK Investigational Site

    Shanghai, 200003, China

  • GSK Investigational Site

    Shanghai, 200031, China

  • GSK Investigational Site

    Suzhou, China

  • GSK Investigational Site

    Wuhan, 430060, China

  • GSK Investigational Site

    Xiamen, 361004, China

  • GSK Investigational Site

    Zhongshan, 528400, China

  • GSK Investigational Site

    Zibo Shandong Province, 255036, China

  • GSK Investigational Site

    Bologna, 40139, Italy

  • GSK Investigational Site

    Catania, 95123, Italy

  • GSK Investigational Site

    Milan, 20132, Italy

  • GSK Investigational Site

    Naples, 80131, Italy

  • GSK Investigational Site

    Padova, 35100, Italy

  • GSK Investigational Site

    Pisa, Italy

  • GSK Investigational Site

    Roma, 00128, Italy

  • GSK Investigational Site

    Roma, 00168, Italy

  • GSK Investigational Site

    Rozzano MI, 20089, Italy

  • GSK Investigational Site

    Varese, 21100, Italy

  • GSK Investigational Site

    Aichi, 471-8513, Japan

  • GSK Investigational Site

    Chiba, 262-0015, Japan

  • GSK Investigational Site

    Chiba, 272-0143, Japan

  • GSK Investigational Site

    Gunma, 373-8585, Japan

  • GSK Investigational Site

    Hyōgo, 650-0047, Japan

  • GSK Investigational Site

    Hyōgo, 665-0827, Japan

  • GSK Investigational Site

    Ibaraki, 309-1793, Japan

  • GSK Investigational Site

    Kanagawa, 211-8533, Japan

  • GSK Investigational Site

    Nagano, 395-8505, Japan

  • GSK Investigational Site

    Shiga, 525-8585, Japan

  • GSK Investigational Site

    Shizuoka, 420-0853, Japan

  • GSK Investigational Site

    Tokyo, 142-8666, Japan

  • GSK Investigational Site

    ?Od?, 90-153, Poland

  • GSK Investigational Site

    Gdansk, 80-214, Poland

  • GSK Investigational Site

    Katowice, 40-611, Poland

  • GSK Investigational Site

    Krakow, 30-033, Poland

  • GSK Investigational Site

    Krakow, 31-513, Poland

  • GSK Investigational Site

    Lubin, 59-300, Poland

  • GSK Investigational Site

    Nadarzyn, 05-830, Poland

  • GSK Investigational Site

    Poznan, 60-355, Poland

  • GSK Investigational Site

    Strzelce Opolskie, 47-100, Poland

  • GSK Investigational Site

    Brasov, 500091, Romania

  • GSK Investigational Site

    Brasov, 500283, Romania

  • GSK Investigational Site

    Bucharest, 014146, Romania

  • GSK Investigational Site

    Bucharest, 014452, Romania

  • GSK Investigational Site

    Cluj-Napoca, 400349, Romania

  • GSK Investigational Site

    Timișoara, 300643, Romania

  • GSK Investigational Site

    Barcelona, 08022, Spain

  • GSK Investigational Site

    Barcelona, 08036, Spain

  • GSK Investigational Site

    Barcelona, 08041, Spain

  • GSK Investigational Site

    Barcelona, 08907, 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

    Madrid, 28041, Spain

  • GSK Investigational Site

    Pamplona, 31008, Spain

  • GSK Investigational Site

    Santander, 39008, Spain

  • GSK Investigational Site

    Seville, 41009, Spain

  • GSK Investigational Site

    Valladolid, 47005, Spain

  • GSK Investigational Site

    Zaragoza, 50009, Spain

  • GSK Investigational Site

    Gothenburg, SE-413 45, Sweden

  • GSK Investigational Site

    Lund, SE-221 85, Sweden

  • GSK Investigational Site

    Stockholm, SE-114 86, Sweden

  • GSK Investigational Site

    Stockholm, SE-171 76, Sweden

  • GSK Investigational Site

    Ankara, 06230, Turkey (Türkiye)

  • GSK Investigational Site

    CapaIstanbul, 34093, Turkey (Türkiye)

  • GSK Investigational Site

    Izmir, 35330, Turkey (Türkiye)

  • GSK Investigational Site

    Tekirdağ, 59100, Turkey (Türkiye)

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