jRCT2041210031进行中（未招募）不适用
A randomized double-blind placebo-controlled parallel group study assessing the efficacy and safety of dupilumab in patients with Allergic Fungal Rhinosinusitis (AFRS)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- Sanofi K.K.
- 入组人数
- 62
- 主要终点
- Change from baseline in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at Week 52
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Treatment Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 6age old over 至 No limit（—）
- 性别
- All
入选标准
- •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.
- •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.
- •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,
- •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
- •Patients who have undergone sinus intranasal surgery (including polypectomy) within 6 months prior to Visit
- •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
- •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
- •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).
结局指标
主要结局
Change from baseline in sinus opacifications assessed by computerized tomography (CT) scans using the Lund Mackay (LMK) score at Week 52
时间窗: Baseline to Week 52
LMK total score is based on assessment of the CT scan findings for each sinus area. The extent of opacification is rated between 0 (normal) to 24 (total opacification).
次要结局
- Change from baseline in sinus opacifications assessed by CT scans using the LMK score at Week 24(Baseline to Week 24)
- Change from baseline in monthly average nasal congestion/obstruction score from the Nasal symptom Diary at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from Baseline in the monthly average anterior/posterior rhinorrhea score from the Nasal Symptom Diary at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in endoscopic NPS compared to placebo at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in 22-item sino-nasal outcome test (SNOT-22) total score at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in monthly average total symptom score (TSS) derived from the Nasal Symptom Diary at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in visual analog scale (VAS) rhinosinusitis at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in University of Pennsylvania smell identification test (UPSIT) at Week 24 and Week 52(Baseline to Week 24 and Week 52)
- Change from baseline in the score of decreased/loss of smell using the Nasal Symptom Diary at Week 24 and Week 52(Baseline to Week 24 and Week 52)
研究者
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