RPCEC00000201

Trial name or title	Randomized controlled double blind trial to study safety and efficaccy of itolizumab (antiCD6) in moderate‐to‐severe psoriasis
Methods	RCT, placebo‐controlled, double‐blind trial Date of study: February 2016 ‐ Location: worldwide Phase 3
Participants	Randomised: 144 participants Inclusion criteria Able and willing to give written informed consent Diagnosis of plaque psoriasis or vulgar Time course of the disease in ≥ 1 year Be tributary of systemic therapy Willingness to complete a washout period prior to receiving the first dose of treatment (for participants in treatment only): interrupting or systemic therapy ≥ 4 weeks; interrupting or topical steroid treatment ≥ 2 weeks Moderate‐severe psoriasis activity, defined by: PASI ≥ 10; BSA ≥ 10% Normal laboratory values, considering laboratory range of each institution: CBC: haemoglobin men ≥ 12.0 g/dL, women ≥ 11.0 g/dL, leukocytes ≥ 5 x109 L, platelets ≥ 150 x 109/L, neutrophils ≥ 1.8 x 109/L, lymphocytes > 1.2 x 109 cells/mL; renal function: creatinine normal value; liver function: ALT, AST, GGT, up to 2.5 times the upper limit of normal Aged 18‐70 years (both included) Exclusion criteria Diagnosis of other types of psoriasis, psoriatic arthritis Critical State of psoriasis (erythroderma) 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 participant's life Malignancy Immunocompromised patient Received systemic retinoids or immunosuppressive therapy including steroids, within < 30 days prior to enrolment, except participants with psoriatic arthritis who are receiving stable treatment for ≥ 30 days prior to inclusion of oral steroids ≤ 10 mg/day Significant acute or chronic systemic infection that to the doctor involves an unreasonable risk to the participant Being treated with a monoclonal antibody, including itolizumab Allergy to any component of the formulation Pregnancy, postpartum and/or breastfeeding Be reproductive age and refuse to use contraception (pills, IUDs, barrier methods, etc) during treatment and ≥ 8 weeks after the last dose of itolizumab 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
Interventions	Intervention Itolizumab: itolizumab 1.6 mg/kg body weight bi‐weekly administered IV by 12 weeks (weeks 0‐8), and every 4 weeks by 24 weeks (Week 12‐36). Control intervention Placebo 1.6 mg/kg body weight bi‐weekly administered intravenously by 12 weeks (weeks 0‐8), then 1.6 mg/kg body weight biweekly administered intravenously by 12 weeks (weeks 12‐20), and every 4 weeks by 12 weeks (weeks 24‐36)
Outcomes	At week 12 Primary outcome PASI 75 Secondary outcomes PASI 50, 75, 90, 100 at weeks 12, 24, 36, 48 and 60 IGA 0/1 at weeks 12, 24, 36, 48 and 60 DLQI at weeks 12, 24, 36, 48 and 60 AEs
Starting date	Start study date: 15/10/2015 Study completion date: not specified
Contact information	Dr Gray Lovio, ogray@infomed.sld.cu
Notes	Ongoing study