NCT07701967招募中4 期
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
适应症
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 28
- 试验地点
- 10
- 主要终点
- 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
研究概览
简要总结
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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Depemokimab + SoC
Experimental
Participants will receive depemokimab along with their existing baseline maintenance CRSwNP standard of care (SOC) treatment (excluding INCS).
干预措施: Depemokimab (Biological)
结局指标
主要结局
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
时间窗: At Week 52
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.
次要结局
- Change from Baseline in Mean Nasal Obstruction Score Using Verbal Response Scale (VRS)(Baseline (Day 1) and from Week 49 through to Week 52)
- Change from Baseline in Mean Symptom Score for Rhinorrhoea (Runny Nose) Using VRS(Baseline (Day 1) and from Week 49 through to Week 52)
- Change from Baseline in Mean Symptom Score for Loss of Smell Using VRS(Baseline (Day 1) and from Week 49 through to Week 52)
- Change from baseline in Lund Mackay Computerised Tomography (CT) score(Baseline (Day 1) and Week 52)
- Change from Baseline in Sino-nasal Outcome Test (SNOT)-22 Score(Baseline (Day 1) and Week 52)
- Change from Baseline in Total Endoscopic NP Score(Baseline (Day 1) and Week 52)
研究者
研究点 (10)
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