JPRN-jRCT2061220020进行中（未招募）3 期
A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) -ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)
Sugiyama Yutaro0 个研究点目标入组 250 人开始时间: 2022年5月28日最近更新:
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 250
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- >= 18age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1.18 years of age and older inclusive, at the time of signing the informed consent.
- •2.Endoscopic bilateral Nasal Polyps (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
- •3.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.
- •4.Participants (except for those in Japan) must be on daily treatment with INCS (including intranasal liquid steroid wash/douching) for at least 8 weeks prior to
- •5.Participants with severe NP symptoms defined as symptoms of nasal congestion/blockade/obstruction with moderate or severe severity (VRS (Verbal response scale) score of 2 or 3) and loss of smell or rhinorrhoea (runny nose)
- •6.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
- •- reduction or loss of smell
- •7.Male or eligible female participants.
排除标准
- •1.As a result of medical interview, physical examination, or screening investigation the physician responsible considers the participant unfit for the study
- •2.Cystic fibrosis
- •3.Antrochoanal polyps
- •4.Nasal cavity tumor (malignant or benign)
- •5.Fungal rhinosinusitis
- •6.Severe nasal septal deviation occluding one nostril preventing full assessment of nasal polyps in both nostrils
- •7.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
- •8.Acute sinusitis or upper respiratory tract infection (URTI) at screening or in 2 weeks prior to screening
- •9.Ongoing rhinitis medicamentosa (rebound or chemical induced rhinitis)
- •10.Participants who have had an asthma exacerbation requiring admission to hospital within 4 weeks of Screening
- •11.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.
- •12.Participants where NP surgery is contraindicated in the opinion of the Investigator
- •13.Eosinophilic Diseases: Participants with other conditions that could lead toelevated eosinophils such as hyper-eosinophilic syndromes including (but not limited to) EGPA (formerly known as Churg-Strauss Syndrome) or Eosinophilic Esophagitis
- •14.Parasitic infection: Participants with a known, pre-existing parasitic infestation within 6 months prior to Visit 1
- •15.Immunodeficiency: A known immunodeficiency (e.g. human immunodeficiency virus - HIV), other than that explained by the use of corticosteroids (CSs) taken as therapy for asthma
- •16.Malignancy: A current malignancy or previous history of cancer in remission for less than 12 months prior to screening.
- •17.Liver Disease:
- •- Alanine aminotransferase (ALT) >2x ULN
- •- Total bilirubin >1.5x ULN (isolated bilirubin >1.5xULN is acceptable if bilirubin is fractionated and direct bilirubin <35%)
- •- Cirrhosis or current unstable liver or biliary disease per investigator assessment defined by the presence of ascites, encephalopathy, coagulopathy, hypoalbuminaemia, oesophageal or gastric varices, persistent jaundice.
- •18.Other Concurrent Medical Conditions: Participants who have known, preexisting, clinically significant cardiac, endocrine, autoimmune, metabolic,neurological, renal, gastrointestinal, hepatic, haematological or any other system abnormalities that are uncontrolled with standard treatment.
- •19.Vasculitis: 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.
- •20.Hypersensitivity: Participants with allergy/intolerance to the excipients of depemokimab, a monoclonal antibody, or biologic.
- •21.COVID-19: Participants that, according to the investigator's medical judgment, are likely to have active 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.
- •22.Participants that have been exposed to ionising radiation in excess of 10mSv above background over the previous 3-year period as a result of occupational exposure or previous participation in research studies.
研究者
相似试验
进行中（未招募）
3 期
ANCHOR-2JPRN-jRCT2031220094Sugiyama Yutaro250
进行中（未招募）
1 期
Investigation of depemokimab (GSK3511294) in patients with chronic rhinosinusitus with nasal polyps (CRSwNP).EUCTR2021-005055-36-ESGlaxoSmithKline, S.A.250
进行中（未招募）
1 期
Investigation of depemokimab (GSK3511294) in patients with chronicrhinosinusitus with nasal polyps (CRSwNP)Chronic Rhinosinusitis with Nasal PolypsMedDRA version: 27.0Level: PTClassification code 10080060Term: Chronic rhinosinusitis with nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-005037-16-BEGlaxoSmithKline Research & Development Limited250
进行中（未招募）
1 期
Investigation of depemokimab (GSK3511294) in patients with chronic rhinosinusitus with nasal polyps (CRSwNP).Chronic Rhinosinusitis with Nasal PolypsMedDRA version: 27.0Level: PTClassification code 10080060Term: Chronic rhinosinusitis with nasal polypsSystem Organ Class: 10038738 - Respiratory, thoracic and mediastinal disordersEUCTR2021-005037-16-DEGlaxoSmithKline Research & Development Limited250
招募中
3 期
A randomised, double-blind, parallel group Phase III study to assess the efficacy and safety of 100 mg SC depemokimab in patients with chronic rhinosinusitis with nasal polyps (CRSwNP) - ANCHOR-1 (depemokimAb iN CHrOnic Rhinosinusitis)Soft growths inside the nosechronic inflammation of the mucous membranes in the nose or sinuses1002765610046304NL-OMON56281GlaxoSmithKline18