JPRN-jRCT2041210031进行中（未招募）3 期
A randomized double-blind placebo-controlled parallel group study assessing the efficacy and safety of dupilumab in patients with Allergic Fungal Rhinosinusitis (AFRS)
Tanaka Tomoyuki0 个研究点目标入组 62 人开始时间: 2021年6月14日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 62
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
- >= 6age old 至 ot applicable（—）
- 性别
- All
入选标准
- •1) Participant must be at least 6 years of age (or the minimum legal age for adolescents in the country of the investigational site) at the time of signing the informed consent.
- •2) Participants with the diagnosis of AFRS adapted from criteria by Bent and Kuhn (meeting all):
- •- IgE mediated inflammatory response to fungal hyphae (specific IgE serology or skin test)
- •Evidence of sensitization to fungus by skin testing (at screening or documented historical positive skin test in the previous 12 months), or positive fungal-specific IgE in serum at screening.
- •- Nasal polyposis confirmed by nasal endoscopy at screening.
- •- Characteristic CT signs to be performed during screening period and can include any of the below signs as assessed by central reader:
- •* hyperdensities
- •* bony demineralization
- •* bone erosion of sinus
- •- Eosinophilic mucin/mucus identified within 5 years prior to screening or at screening with or without positive fungal stain.
- •3) AFRS patients with the following:
- •- An endoscopic Nasal Polyp Score (NPS) of at least 2 out of 4 for unilateral polyps or 3 out of 8 for bilateral polyps at Visit 1 (central reading) and Visit 2 (local reading) and,
- •- Sinus opacification in CT scan with an Lund Mackay (LMK) score of 9 for patients with unilateral polyps or 12 for patients with bilateral polyps during screening period and,
- •4) Body weight >=15 kg
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •- Patients with nasal conditions/concomitant nasal diseases making them non-evaluable at Visit 1 or for the primary efficacy.
- •- Nasal cavity malignant tumor and benign tumors.
- •- Known of fungal invasion into sinus tissue.
- •- 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
- •- 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.
- •- Treatment with commercially available dupilumab within 12 months, participation in prior dupilumab clinical trial, or 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.
- •- Patients who are on intranasal corticosteroids (INCS) spray unless they have received stable dose for at least 4 weeks prior to Visit 1.
- •- Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit 1.
- •- Patients who have taken:
- •* Biologic therapy/systemic immunosuppressant to treat inflammatory disease or autoimmune disease within 5 half-lives prior to Visit 1
- •* Any investigational mAb within 5 half-lives prior to Visit 1
- •* Anti-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.
- •- Either intravenous immunoglobulin therapy and/or plasmapheresis within 30 days prior to Screening Visit (Visit 1).
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