EUCTR2020-003117-35-HU进行中（未招募）1 期
A randomized, double-blind, placebo-controlled, 2-part study to evaluate the efficacy and safety of dupilumab in patients with uncontrolled, chronic rhinosinusitis without nasal polyposis (CRSsNP) - Liberty CRSsNP ORIO
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 437
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Part A only: Participant must be at least 18 years of age at the time of signing the informed consent form (ICF).
- •- Part B only: Participant must be at least 12 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the ICF.
- •- Participants must have bilateral inflammation of paranasal sinuses in CT scan with LMK =8 and bilateral ethmoid opacification before randomization.
- •- Participants must have ongoing symptoms of loss of smell and rhinorrhea (anterior/posterior) of any severity, with or without facial pain/pressure for at least 12 consecutive weeks by Visit 1.
- •- Participants must have ongoing symptoms of nasal congestion (NC)/obstruction at least 12 consecutive weeks before Visit 1 and a NC score of = 2 at Visit 1 (day score) and Visit 2 (weekly average score).
- •- Participants must have sTSS (NC, rhinorrhea, facial pain/pressure) =5 at Visit 1 (day score) and Visit 2 (weekly average score).
- •- Participants must have one of the 2 following features:
- •oPrior sinonasal surgery (see note at end of section 5.2 for definitions of sinonasal surgery) for CRS,
- •oComorbid asthma,
- •oTreatment with SCS therapy for CRS as defined by any dose and duration within the prior 2 years before screening (Visit 1) or intolerance/contraindication to SCS.
- •- For Part B only: participants who have a blood eosinophil count =300 cells/mm3 at Screening
- •- Body weight =30 kg.
- •Are the trial subjects under 18? yes
- •Number of subjects for this age range: 9
- •F.1.2 Adults (18-64 years) no
- •F.1.2.1 Number of subjects for this age range 371
- •F.1.3 Elderly (>=65 years) no
- •F.1.3.1 Number of subjects for this age range 44
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Patients with nasal conditions/concomitant nasal diseases such as nasal polyposis in endoscopy at Visit 1 or with history of nasal polyposis etc., making them non-evaluable at Visit 1 or for the primary efficacy
- •- Nasal cavity malignant tumor and benign tumors.
- •- Forced expiratory volume (FEV1) =50% of predicted normal at Visit 1.
- •- Radiologic suspicion or confirmed invasive or expansive fungal rhinosinusitis.
- •- Severe concomitant illness(es) that, in the investigator’s judgment, would adversely affect the patient’s participation in the study
- •- Active tuberculosis or non-tuberculous mycobacterial infection, or a history of incompletely treated tuberculosis unless documented adequately treated.
- •- Diagnosed active endoparasitic infections; suspected or high risk of endoparasitic infection
- •- Known or suspected immunodeficiency
- •- History of malignancy within 5 years before Visit 1, except completely treated in situ carcinoma of the cervix, and completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin.
- •- Active chronic or acute infection requiring treatment with systemic antibiotics, antivirals, or antifungals within 2 weeks before the Screening Visit 1 or during the screening period.
- •- History of systemic hypersensitivity or anaphylaxis to dupilumab or any of its excipients.
- •- Patients in prior dupilumab clinical trial or have been treated with commercially available dupilumab within 12 months or who discontinued dupilumab use due to adverse event.
- •- Patients who are treated with intranasal corticosteroid drops; intranasal steroid emitting devices/stents; nasal spray using exhalation delivery system, such as Xhance™, during screening period.
- •- Participants on unstable dose of INCS spray 4 weeks prior to Screening Visit (Visit1) and during screening period.
- •- Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
- •- Patients who have taken:
- •oBiologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1
- •oAny investigational mAb within 5 half-lives prior to Visit 1
- •oAnti-IgE therapy (omalizumab) within 4 months prior to Visit 1.
- •-Treatment with a live (attenuated) vaccine within 4 weeks prior to Visit 1
- •- Leukotriene antagonists/modifiers unless patient is on a continuous treatment for at least 30 days prior to Visit 1.
- •- Initiation of allergen immunotherapy within 3 months prior to Visit 1 or a plan to begin therapy or change its dose during the screening or treatment period.
- •- Patients received SCS during screening period(between Visit 1 and Visit 2).
- •- Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1).
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