EUCTR2015-001314-10-BE进行中（未招募）1 期
A Randomized, Double-blind, 52-week, Placebo Controlled Efficacy and Safety Study of Dupilumab, in Patients with Bilateral Nasal Polyposis on a Background Therapy with Intranasal Corticosteroids - SINUS-52
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 448
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
- •-Patients with bilateral sinonasal polyposis that despite prior treatment with systemic corticosteroids (SCS) anytime within the past 2 years; and/or have a medical contraindication/intolerance to SCS, and/or had prior surgery for NP at the screening visit, have:
- •-An endoscopic bilateral NPS of at least 5 out of a maximum score of 8 (with a minimum score of 2 in each nasal cavity).
- •-Ongoing symptoms (for at least 8 weeks before V1) of nasal congestion/ blockage/obstruction with moderate or severe symptom severity (score 2 or 3) at V1 and a weekly average severity of greater than 1 at time of randomization (V2), and another symptom such as loss of smell, rhinorrhea (anterior/posterior).
- •-Signed written informed consent.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 655
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 65
排除标准
- •- Patients <18 years of age.
- •- Patient who has been previously treated in dupilumab studies.
- •- Patient who has taken:
- •-Biologic therapy/ systemic immunosuppressant to treat inflammatory disease or autoimmune disease (eg, rheumatoid arthritis, inflammatory bowel disease, primary biliary cirrhosis, systemic lupus erythematosus, multiple sclerosis, etc.) within 2 months before V1 or 5 half-lives, whichever is longer.
- •-Any experimental monoclonal antibody (mAB) within 5 half-lives or within 6 months before V1 if the half-life is unknown.
- •-Anti-immunoglobulin E therapy (omalizumab) within 130 days prior to V1.
- •-Patients who are receiving leukotriene antagonists/modifiers at V1 unless they are on a
- •continuous treatment for at least 30 days prior to V1.
- •- Initiation of allergen immunotherapy within 3 months prior to V1 or a plan to begin therapy or change its dose during the run-in period or the randomized treatment period.
- •- Patients who have undergone any intranasal and/or sinus surgery (including polypectomy) within 6 months before V1.
- •- Patients who have had a sinonasal or sinus surgery changing the lateral wall structure of the nose making impossible the evaluation of NPS.
- •- Patients with conditions/concomitant diseases making them non evaluable at V1 or for the primary
- •efficacy endpoint such as:
- •-Antrochoanal polyps,
- •-Nasal septal deviation that would occlude at least one nostril,
- •-Acute sinusitis, nasal infection or upper respiratory infection,
- •-Ongoing rhinitis medicamentosa,
- •-Allergic granulomatous angiitis (Churg-Strauss syndrome), granulomatosis with polyangiitis (Wegener’s granulomatosis),Young’s syndrome, Kartagener’s syndrome or other dyskinetic ciliary
- •syndromes, concomitant cystic fibrosis,
- •-Radiologic suspicion, or confirmed invasive or expansive fungal rhinosinusitis.
- •- Patients with nasal cavity malignant tumor and benign tumors (eg, papilloma, blood boil etc.).
- •- Patients with forced expiratory volume (FEV1) 50% or less (of predicted normal).
- •- Patients receiving concomitant treatment prohibited in the study.
- •- Treatment with a live (attenuated) vaccine within 12 weeks before the baseline visit.
- •- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •- Positive with hepatitis B surface antigen (HBsAg) or hepatitis C antibody at the screening visit.
- •- Active chronic or acute infection requiring systemic treatment within 2 weeks before the Baseline visit.
- •- Known or suspected history of immunosuppression.
- •- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •- Women unwilling to use adequate birth control, if of reproductive potential and sexually active.
- •Note: The information listed above is not intended to contain all considerations relevant to a patient's potential participation in this clinical trial therefore not all inclusion/ exclusion criteria are listed.
研究者
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