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Nasal PolypsPhase 4NCT07701967

Efficacy and Safety of Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)

A Phase 4 study testing Depemokimab in people with Nasal Polyps, run by GlaxoSmithKline at 10 sites in Japan.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) without concomitant use of Intranasal corticosteroids (INCS) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP). Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Nasal Polyps
What is being tested?
Depemokimab
Could I receive a placebo?
No, everyone receives an active treatment
How many people
28 participants
Where
10 sitesJapan
Study dates
15 Jul 2026to 13 Jun 2028
Phase
Phase 4
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 29Show fewer
  • 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

Trial locations and contacts

10 sites in 1 country. Contact the study team or a site near you to ask about taking part.

US GSK Clinical Trials Call Center contact

877-379-3718

GSKClinicalSupportHD@gsk.com

EU GSK Clinical Trials Call Center contact

+44 (0) 20 89904466

GSKClinicalSupportHD@gsk.com

10 sites in 1 country

Japan10 sites, 10 recruiting
  • GSK Investigational Site

    Ehime, 790-0024

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Ehime, 798-8510

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Fukui, 910-1193

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Fukuoka, 806-8501

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Gunma, 373-8585

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Nagano, 392-8510

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Osaka, 583-8588

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Saitama, 336-8522

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Shiga, 525-8585

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting
  • GSK Investigational Site

    Shizuoka, 420-0853

    US GSK Clinical Trials Call Center, 877-379-3718, GSKClinicalSupportHD@gsk.com

    EU GSK Clinical Trials Call Centre, +44 (0) 20 8990 4466, GSKClinicalSupportHD@gsk.com

    Recruiting

Other trials in Japan

About this study

Official title: A Phase IV, Single-arm, Open-label Study to Evaluate the Efficacy and Safety of 100 mg SC Depemokimab Monotherapy Without Concomitant Use of Intranasal Corticosteroids (INCS) in Japanese Participants With Chronic Rhinosinusitis With Nasal Polyps (CRSwNP) Who Are Inadequately Controlled With Standard Treatment

This study will evaluate the efficacy and safety of depemokimab (GSK3511294) without concomitant use of Intranasal corticosteroids (INCS) in participants with Chronic rhinosinusitis with nasal polyps (CRSwNP).

Conditions
Nasal Polyps
Being tested
Depemokimab
Keywords
Depemokimab, GSK3511294, Chronic rhinosinusitis with nasal polyps, CRSwNP, Phase IV clinical trial, Japanese participants, Efficacy, Safety, Monotherapy
Medical subject headings
Nasal Polyps

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DepemokimabBiological

    Also called GSK3511294

    Participants will receive depemokimab.

Study groups in NCT07701967
Study groupRoleWhat they receive
Depemokimab + SoCExperimentalParticipants will receive depemokimab along with their existing baseline maintenance CRSwNP standard of care (SOC) treatment (excluding INCS).
Receives: Biological: Depemokimab

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Percentage of Participants Achieving a One-point or Greater Decrease from Baseline in Total Endoscopic Nasal Polyp (NP) Score Without First Having Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP

    The total endoscopic NP score will evaluate the size and extent of nasal polyps via endoscopy. The assessments will be performed using centrally reviewed video recordings of nasal endoscopy. The right and left nostrils will be scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores will be graded based on NP size and will be recorded as the sum of the right and left nostril scores, ranging from 0 (no polyps) to 8 (large polyps), calculated by summing the scores [0 to 4] in each nostril, with higher scores indicating worse status.

    Measured: At Week 52

Secondary outcomes (6)
  1. Change from Baseline in Total Endoscopic NP Score

    The total endoscopic NP score will evaluate the size and extent of nasal polyps via endoscopy. The assessments will be performed using centrally reviewed video recordings of nasal endoscopy. The right and left nostrils will be scored from 0 to 4 (0 = No polyps; 1 = Small polyps in the middle meatus not reaching below the inferior border of the middle concha; 2 = Polyps reaching below the lower border of the middle turbinate; 3 = Large polyps reaching the lower border of the inferior turbinate or polyps medial to the middle concha; and 4 = Large polyps causing complete obstruction of the inferior meatus). The scores will be graded based on NP size and will be recorded as the sum of the right and left nostril scores, ranging from 0 (no polyps) to 8 (large polyps), calculated by summing the scores [0 to 4] in each nostril, with higher scores indicating worse status.

    Measured: Baseline (Day 1) and Week 52

  2. Change from Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale (VRS)

    Participants will use a VRS to rate nasal obstruction severity, with scores to be averaged over the specified period to assess treatment impact on nasal obstruction symptoms. Participants will be asked to indicate the severity of nasal obstruction at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.

    Measured: Baseline (Day 1) and from Week 49 through to Week 52

  3. Change from Baseline in Mean Symptom Score for Rhinorrhoea (Runny Nose) Using VRS

    Participants will be asked to indicate the severity of rhinorrhoea (runny nose) at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.

    Measured: Baseline (Day 1) and from Week 49 through to Week 52

  4. Change from Baseline in Mean Symptom Score for Loss of Smell Using VRS

    Participants will be asked to indicate the severity of loss of smell at its worst over the last 24 hours using a 4-point VRS, with options of no symptoms, mild symptoms, moderate symptoms, and severe symptoms. This will be scored on a scale ranging from 0 (no symptoms) to 3 (severe symptoms), with higher scores indicating worse status. The average of daily scores in 4-weekly intervals will be calculated, and data will be presented for Weeks 49-52.

    Measured: Baseline (Day 1) and from Week 49 through to Week 52

  5. Change from baseline in Lund Mackay Computerised Tomography (CT) score

    The LMK CT scoring system is based on CT imaging of the sinuses, with points to be given for the degree of opacification: 0 = normal, 1 = partial opacification, and 2 = total opacification. These points will be applied to the maxillary, anterior ethmoid, posterior ethmoid, sphenoid, and frontal sinuses on each side (right and left). The osteomeatal complex (OC) will be graded as 0 = not occluded or 2 = occluded. The range for the total LMK CT score will therefore be 0 (normal) to 24 (total opacification) when summed across both sides, with higher scores indicating more severe disease.

    Measured: Baseline (Day 1) and Week 52

  6. Change from Baseline in Sino-nasal Outcome Test (SNOT)-22 Score

    The SNOT-22 is a 22-item measure of disease-specific health-related quality of life (HRQoL). Participants will be asked to rate the severity of their condition on each of the 22 items over the previous 2 weeks using a 6-point rating scale of 0-5, including: 0 = Not present/no problem; 1 = Very mild problem; 2 = Mild or slight problem; 3 = Moderate problem; 4 = Severe problem; and 5 = Problem "as bad as it can be." The scores for each question will be summed to derive the total score, with the SNOT-22 total score ranging from 0 (high quality of life) to 110 (worst quality of life), where higher scores will indicate worse quality of life.

    Measured: Baseline (Day 1) and Week 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Jul 2026
  2. Study start15 Jul 2026
  3. Primary completion28 Jun 2027 (estimated)
  4. Study completion13 Jun 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
28 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07701967
Sponsor's protocol ID
307355
Status last verified
Sep 2026
First submitted
9 Jul 2026
Last updated
8 Sep 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Yes: Study Sponsor will assess requests from qualified researchers for anonymized individual patient-level data and related study documents. Data sharing is subject to certain criteria, conditions, and exceptions. For further information, refer to https://www.gsk-studyregister.com/gsk-patient-level-data-sharing-july2025.pdf

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Depemokimab in people with Nasal Polyps, run by GlaxoSmithKline at 10 sites in Japan.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 29 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 8 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 10 sites in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact US GSK Clinical Trials Call Center (877-379-3718, GSKClinicalSupportHD@gsk.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Percentage of Participants Achieving a One-point or Greater Decrease from Baseline in Total Endoscopic Nasal Polyp (NP) Score Without First Having Nasal Surgery (Actual) or Disease-Modulating Medication for CRSwNP (time frame: At Week 52). It is what the study was designed to measure, not a finding.

Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.

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