Itolizumab for Moderate-to-Severe Psoriasis-phase 3
- Conditions
- Moderate-to-Severe PsoriasisPsoriasisSkin Diseases, PapulosquamousSkin Diseases
- Registration Number
- RPCEC00000201
- Lead Sponsor
- Center of Molecular Immunology (CIM)
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Pending
- Sex
- All
- Target Recruitment
- 144
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Proportion of subjects achieving PASI75 (patients with improvement in PASI score = 75% from baseline, Day 0). Measuring time: at Week 12
- Secondary Outcome Measures
Name Time Method