Could a single biologic replace steroid sprays for nasal polyps?
NCT ID NCT07701967
First seen Jul 14, 2026 · Last updated Sep 09, 2026 · Updated 3 times
Summary
This study tests whether the biologic drug depemokimab, given as a shot, can shrink nasal polyps in Japanese adults with chronic sinusitis and nasal polyps who have not been helped by standard treatments. Participants receive depemokimab without using steroid nasal sprays. The main goal is to see if the drug reduces polyp size by at least one point on an 8-point scale without needing surgery or other medications.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- an experimental biologic drug called depemokimab
- What this could lead to
- If successful, this could offer a steroid-free treatment option for nasal polyps, reducing the need for surgery or oral steroids.
- What could go wrong
- This is a small, early-phase study in Japanese patients only, so results may not apply broadly. The drug may not shrink polyps enough or could cause side effects.
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
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 28 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2026
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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: * 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 previous nasal surgery for the removal of nasal polyps, have used at least three consecutive days of systemic corticosteroids in the previous 2 years for the treatment of nasal polyps, or are medically unsuitable or intolerant to systemic corticosteroid * Participants presenting with severe nasal polyp symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity and loss of smell or rhinorrhoea (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), or facial pain/pressure and/or reduction or loss of smell * Male or eligible female participants 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 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.NOTE: Participants that had localised carcinoma of the skin which was resected for cure will not be excluded * 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 enrolment * Participants with allergy/intolerance to the excipients of depemokimab, a monoclonal antibody, or biologic * 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 * Participants using INCS (including intranasal liquid steroid wash/douching) for at least 8 weeks immediately prior to screening * Participants on inhaled corticosteroids exhalation through nose (Inhaled corticosteroids exhalation through nose \[ICS/ETN\]) method of administration for their asthma and NP for at least the 8 weeks immediately prior to screening * Participants who have received depemokimab (Exdensur), mepolizumab (Nucala), reslizumab (Cinqair/Cinqaero), or benralizumab (Fasenra) within 12 months prior to Visit 1 or experienced treatment failure with monoclonal antibodies targeting IL-5/5R * Participants who have received omalizumab (Xolair), dupilumab (Dupixent) or Tezpelumab (Tezpire) within 130 days prior to Visit 1 * Previously participated in any study with depemokimab, 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 * ALT \>2\* ULN * Total bilirubin \>1.5\* ULN; For participants with Gilbert's syndrome can be included with total bilirubin \>1.5\* ULN if direct bilirubin is \<=1.5\* ULN * 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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
10 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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GSK Investigational Site
RECRUITINGEhime, 790-0024, Japan
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GSK Investigational Site
RECRUITINGEhime, 798-8510, Japan
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GSK Investigational Site
RECRUITINGFukui, 910-1193, Japan
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GSK Investigational Site
RECRUITINGFukuoka, 806-8501, Japan
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GSK Investigational Site
RECRUITINGGunma, 373-8585, Japan
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GSK Investigational Site
RECRUITINGNagano, 392-8510, Japan
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GSK Investigational Site
RECRUITINGOsaka, 583-8588, Japan
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GSK Investigational Site
RECRUITINGSaitama, 336-8522, Japan
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GSK Investigational Site
RECRUITINGShiga, 525-8585, Japan
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GSK Investigational Site
RECRUITINGShizuoka, 420-0853, Japan
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Other studies related to the condition(s) this trial covers.
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