Randomized controlled double blind trial to study Safety and Efficaccy of itolizumab (antiCD6) in Moderate-to-Severe Psoriasis.

Center of Molecular Immunology (CIM)0 个研究点目标入组 144 人开始时间: 2015年10月8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: Randomized controlled trial. Masking: Double Blind. Control group: Placebo. Assignment: Crossover. Purpose: Treatment

•1. Able and willing to give written informed consent.
•2. Diagnosis of plaque psoriasis or vulgar.
•3. Time course of the disease in at least 1 year.
•4. Be tributary of systemic therapy.
•5. Willingness to complete a washout period prior to receiving the first dose of treatment (for patients in treatment only): Interrupting or systemic therapy at least four weeks; Interrupting or topical steroid treatment at least 2 weeks
•6. moderate to severe psoriasis activity, defined by: Area and Severity Index (PASI) = 10; affected body surface area (BSA) = 10%
•7. Normal laboratory values, considering laboratory range of each institution: CBC: Hemoglobin-man = 12.0 g / dl, -women = 11.0 g / dl, leukocytes = 5x109 L, platelets = 150x109 / L, neutrophils = 1.8x109 / L, lymphocytes> 1.2x109 cells / mL; Renal function: Creatinine normal value; Liver function: ALT, AST, GGT, up to 2.5 times the ULN.
•8. Age between 18 and 70 years (both included).

•1. Diagnosis of other types of psoriasis, psoriatic arthritis except.
•2. Critical State of psoriasis (erythroderma).
•3. Suffering from decompensated chronic diseases (heart disease, diabetes mellitus, hypertension, chronic kidney disease, bronchial asthma, etc) to the doctor involves an unreasonable risk to the patient's life.
•4. Malignancy.
•5. immunocompromised patient.
•6. Have received systemic retinoids or immunosuppressive therapy including steroids, within less than 30 days prior to enrollment, except patients with psoriatic arthritis who are receiving stable treatment for at least 30 days prior to inclusion of oral steroids =10 mg /day.
•7. significant acute or chronic systemic infection that to the doctor involves an unreasonable risk to the patient.
•8. Being treated with a monoclonal antibody, including itolizumab.
•9. allergy to any component of the formulation.
•10. Pregnancy, postpartum and / or breastfeeding.
•11. Be reproductive age and refuse to use contraception (pills, IUDs, barrier methods, etc) during treatment and at least 8 weeks after the last dose of itolizumab.
•12. Suffering intellectual or sensory psychological dysfunction that may impede understanding and compliance with the requirements of the study at the discretion of the clinical investigator.

发起方

Center of Molecular Immunology (CIM)