Safety and Therapeutic Effect Study of itolizumab mAb in patients with severe psoriasis.

Center of Molecular Immunology (CIM)0 个研究点开始时间: 2012年7月20日最近更新: 2024年8月19日

适应症

试验速览

暂无简介。

研究类型: Interventional
分配方式: N/a: Single Arm Study. Masking: Open. Control Group: Uncontrolled. Assignment: Single Group. Purpose: Treatment

•1. Age 18-75 years (Both inclusive), of any gender or skin color 2. Patients with clinical and histopatological diagnozed of active severe psoriasis 3. Patients must have been treated unsuccessfully with, or who are intolerant to or have a contraindication to receiving anti-psoriatic treatments currently available in the country. 4. Baseline PASI =10 5. Patients receiving immunosupressive therapy (including retinoids) for Psoriasis can be included after a washout period of 4 weeks. Oral Glucocorticoids =10 mg/day permitted if stable prior to baseline for Psoriatic arthritis patients. 6. Patients comply with the requirements of the clinical laboratory: •Hemoglobin, men =12.0 g/dL, women =11.0 g/dL, WBC> 3x109 cells / mL, ALC >1.3x109 cel/ml, platelet count > 150x109/mL, ANC= 1,5x109 /L •Creatinine within the normal reference values (UI). •Transaminase (TGP), bilirrubin and alcaline fosfatase (AF) within the normal reference values (UI). 7. Able and willing to give written informed consent.

•1. Uncompensated suffering from chronic diseases (heart diseases, diabetes mellitus, hypertension, chronic renal failure, bronchial asthma) 2. History of or Suffering from any malignancy (including solid tumours, hematologic malignancies and carcinoma in situ) 3. History of Chronic or current infectious disease (at screening patients with chest radiograph and laboratory test) 4. Pregnancy, childbirth and / or breastfeeding. 5. Patients who refuse to use contraception during the study. 6. Patients with intellectual or psychological dysfunction that not allow to understand and compliance with study requirements, according to the Principal Investigator.

发起方

Center of Molecular Immunology (CIM)