EUCTR2009-009498-87-DE进行中（未招募）不适用
A Phase II, Multicenter, Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Study Of Xolair (Omaluzimab) In Patients With Chronic Idiopathic Urticaria (CIU) Who Remain Symptomatic With Anithistamine Treatment (H1)
适应症
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 76
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
- •1) Signed Informed Consent Form
- •2) Aged 12-75 years (in Germany, 18-75 years)
- •3) Diagnosis of moderate to severe CIU at the time of screening, as defined by pruritus and hives for > 3 days in a 7-day period for > 6 consecutive weeks despite treatment with H1 antihistamine
- •4) CIU diagnosis > 3 months (by history)
- •5) The non-diary based UAS score >= 4 established in the clinic at the time of screening visit (Week -2) and at run-in visit (Week -1)
- •6) A diary-based UAS7 score = 12 (equivalent of moderate to severe CIU) at the time of randomization (Week 0) despite stable doses of H1 antihistamine
- •7) No underlying etiology clearly defined for urticaria (main manifestation cannot be physical urticaria)
- •8) Compliance with study procedures during run-in period (e.g., completion of the study diary)
- •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
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range
排除标准
- •1) Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive Human Chorionic Gonadotropin test. Women of childbearing potential and not practicing a medically approved method of contraception during and up to at least 4 weeks after the end of treatment. Medically approved” contraception may include implants, injectables, combined oral contraceptives, intrauterine devices, and also abstinence, at the discretion of the investigator.
- •2) Patients < 40kg
- •3) Treatment with any investigational agent within 30 days of screening
- •4) Recent history of drug or alcohol abuse (within 3 years prior to Visit 1)
- •5) Atopic dermatitis or other skin disease associated with pruritus
- •6) Clinically relevant major systemic disease (making interpretation of the study results difficult)
- •7) Inability to comply with study and follow-up procedures
- •8) Previously treated with omalizumab (< 12 months since last injection)
- •9) Patients may not take during treatment period or have been taking within the past 3 months any of the following medications/treatments: regular (daily/every other day) hydroxychloroquine, sulfasalazine, dapsone, methotrexate, cyclosporine, cyclophosphamide, IVIG, plasmapheresis, or other monoclonal antibody therapies
- •10)Patients may not have been taking cyclosporine within the past month prior to screening
- •11) Patients may not take doxepin during screening, run-in or treatment period or have been taking doxepin within the past 6 weeks regular (daily/every other day) prior to screening
- •12) Patients may not take systemic corticosteroids or cutaneous corticosteroid (intranasal, inhaled, and ophtahalmic steroids are permitted) during the screening, run-in, or treatment periods
- •13) Patients may not take H2 antihistamines and leukotriene receptor antagonists within 7 days before screening, during the screening, run in, or treatment phases
- •14) Contraindications to diphenhydramine: Overreactivity against the agent dyphenhydramine, other antihistaminic agents, or other components of this agent; acute bronchial asthma; acute angle-closure glaucoma; pheochromocytoma; hyperplasia of the prostate gland with formation of residual urine; epilepsy; hypokalemia; hypomagnesemia; bradycardia; a congenital long QT syndrome or other clinically significant cardial disorders (especially coronary heart disease, disturbances in conduction, arrhythmias); the simultaneous application of drugs which prolong the QT interval (e.g., antiarrhythmic drugs class IA or III, antibiotics, cisapride, malaria drugs, antihistaminic drugs, neuroleptic drugs) or lead to hypokalemia (e.g., certain diuretic drugs); the simultaneous application of MAO inhibitors; the simultaneous uptake of alcohol.
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