EUCTR2015-002321-20-GR进行中（未招募）1 期
A DOUBLE-BLIND, RANDOMISED, PLACEBO-CONTROLLED CLINICAL TRIAL OF THE SAFETY AND EFFICACY OF MABp1, A HUMAN ANTIBODY TARGETING INTERLEUKIN-1ALPHA, IN PATIENTS WITH HIDRADENITIS SUPPURATIVA - MABp1 FOR THE MANAGEMENT OF HIDRADENITIS SUPPURATIVA
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
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
- •Written informed consent provided by the patient
- •Age above or equal to 18 years
- •Diagnosis of hidradenitis suppurativa (HS)
- •Presence of at least three inflamed nodules
- •HS of Hurley II or III stage disease or rapidly progressive HS of stage I
- •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 40
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 40
排除标准
- •History of systemic lupus erythematosus, of rheumatoid arthritis or of seronegative inflammatory arthritis
- •Treatment with any biologicals or investigational agents within the last 4 weeks (or 5 half-lives, whichever is longer)
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies
- •Administration of any live (attenuated) vaccine over the last 4 weeks
- •History of recurrent vein thrombosis or embolism compatible with anti-cardiolipin syndrome
- •Any present serious bacterial infection namely pneumonia, endocarditis, acute pyelonephritis and intrabdominal infection. These patients can be enrolled once the attending physicians confirm cure by the infection
- •Hepatic dysfunction defined as any value of transaminases, of ?-glutamyl transpeptidase or of bilirubin greater than twofold the upper normal limit
- •History of haematological or solid tumor malignancy, arterial hypertension, liver cirrhosis, HIV infection, and hepatitis virus B or C infection
- •History of episodes mimicking demyelinating disorders or a definite diagnosis of multiple sclerosis
- •Any creatinine value above 1.5 mg/dl
- •Intake of corticosteroids defined as daily intake of prednisone or equivalent more than 1mg/kg for the last three weeks;
- •Neutropenia defined as lower than 1000 neutrophils/mm3; and
- •Pregnancy or lactation
- •History of tuberculosis (latent or active). This will be excluded according to the procedure defined in the screening of patients (see below)
- •Major surgery within 28 days prior to Day 0
研究者
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