NCT00822783已完成4 期
An Exploratory 16 Week, Double Blind, Placebo-Controlled Single Center Mechanistic Study to Determine the Effect of Rhumab-E25 on Phenotype and Function of IgE Mediated Antigen Presentation by Dendritic Cells in Subjects With Atopic Dermatitis.
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 试验地点
- 1
研究概览
简要总结
Elevated levels of immunoglobuline E in blood are said to promote the occurence of atopic dermatitis; in fact, many patients with atopic dermatitis have high IgE levels. This study tried to explore whether the depletion of IgE from blood and skin might result in a change of immunological parameters and might alter the clinical course of the disease.
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 12 Years 至 60 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •aged between 12 and 60 years
- •clinical diagnosis of AD (criteria of Hanifin and Rajka, 1980)
- •serum IgE between 30 and 1,300 IU/ml
- •at least one significantly positive RAST
- •a positive skin prick test of the same specificity as the RAST
- •an Investigator's Global Assessment Score of 2 or more at randomization
- •stable AD, as defined as active AD (IGA 2 or more) for > 9 months per year
- •signed informed consent.
排除标准
- •pregnant or nursing females or women of childbearing potential who did not use a reliable contraceptive method
- •treatment with omalizumab within the last 12 months before study treatment
- •known hypersensitivity to any ingredients of omalizumab or omalizumab- related drugs
- •elevated serum IgE levels for reasons other than atopy
- •ongoing immunotherapy
- •use of long-acting antihistamine astemizol within 3 months prior to visit1
- •use of medium-acting antihistamines (e.g. loratadine, cetirizine) within 5 days prior to visit 1
- •use of short-acting antihistamines (e.g. diphenhydramin, terfenadine) within 3 days prior to visit 1
- •use of zafirlukast or other leukotriene receptor inhibitors and zileuton or other 5-lipoxygenase enzyme inhibitors within 3 days prior to visit 1
- •use of phototherapy or systemic therapy that is known or suspected to have had an effect on AD within 1 month prior to first application of study medication
- •treatment with topical therapy (other than hydrocortisone 1%) that is known or suspected to have had an effect on AD within 14 days prior to first application of study medication
- •use of systemic steroids (oral, intravenous, including intraarticular and rectal) within one month prior to first application of study medication. (Patients on a stable maintenance dose of inhaled steroids were allowed to participate)
- •use of systemic antibiotics within 2 weeks prior to first application of study medication
- •use of tranquilizers, hypnotic agents or tricyclic antidepressants within 2 weeks prior to the start of the study
- •immunocompromised patients or patients having a history of malignant disease
- •concurrent skin diseases
- •active bacterial, viral or fungal infections that required treatment with a prohibited medication
- •a history of recurrent herpes simplex infection having active lesions at baseline
- •tinea corporis / tinea cruris
- •clinically significant laboratory abnormalities
- •a history of noncompliance to medical regimens and patients who were considered potentially unreliable
- •evidence of drug or alcohol abuse or other factors limiting ability to fully cooperate
- •any condition or prior/continuing treatment which, in the opinion of the investigator, should have rendered the patient ineligible for the study.
研究组 & 干预措施
Omalizumab
Active Comparator
干预措施: Omalizumab (Drug)
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
研究者
研究点 (1)
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