DRKS00004643已完成2 期
rticaria facticia Treatment with Omalizumab - UFO
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 61
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 study
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 75 Years（—）
- 性别
- All
入选标准
- •Adults (18-75 years)
- •Informed consent signed and dated
- •Able to read, understand and willing to sign the informed consent form and abide with study procedures
- •Diagnosis of UF lasting for at least 6 months
- •Willing, committed and able to return for all clinic visits and complete all study-related procedures, including willingness to have SC injections administered by a qualified person
- •In females of childbearing potential: Negative pregnancy test; females willing to use highly effective contraception (Pearl-Index < 1). A woman will be considered not of childbearing potential if she is post-menopausal for greater than two years or surgically sterile (bilateral tubal ligation, bilateral oophorectomy or hysterectomy)
- •No participation in other clinical trials 4 weeks before and after participation in this study
排除标准
- •Patients with acute urticaria
- •Concurrent/ongoing treatment with immunosuppressives (e.g. systemic steroids, cyclosporine, methotrexate, dapsone or others) within 4 weeks or 5 half lives prior to day 0, whichever is longer
- •Significant medical condition rendering the patient immunocompromised or not suitable for a clinical trial
- •Significant concomitant illness that would adversely affect the subject’s participation or evaluation in this study
- •History of malignancies within five years prior to screening other than a successfully treated non-metastatic cutaneous, basal, or squamous cell carcinoma and/or in situ cancer
- •Presence of clinically significant laboratory abnormalities
- •Lactating females or pregnant females
- •Subjects for whom there is concern about compliance with the protocol procedures
- •Any medical condition which, in the opinion of the Investigator, would interfere with participation in the study or place the subject at risk
- •History of substance abuse (drug or alcohol) or any other factor (e.g., serious psychiatric condition) within the last 5 years that could limit the subject’s ability to comply with study procedures
- •Subjects who are detained officially or legally to an official institute
- •Previous use of omalizumab within the last 6 months
- •Intake of antihistamines or leukotriene antagonists within 7 days prior to visit 1
- •Intake of oral corticosteroids within 14 days prior to visit 1
- •Use of depot corticosteroids or chronic systemic corticosteroids within 21 days before beginning of the study
- •Known hypersensitivity to any ingredients, including excipients (sucrose, histidine, polysorbate 20) of the study medication or drugs related to omalizumab (e.g.: monoclonal antibodies, polyclonal gammaglobulin)
研究者
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