Multicenter, dose response, randomized, double blin, parallel, 3 arms, placebo controlled clinical trial to evaluate the efficacy and the safety of subcutaneous CDP870 (certolizumab pegol) at 2 different 12 weeks dose regimens followed by a minimum of 12 wks of follow-up without treatment (or until relapse) in subjects suffering from moderate- to-severe chronic plaque psoriasis who are candidates for systemic therapy and/or phototherapy and/or photochemotherapy. - CDP870-040

Conditions: Psoriasis
MedDRA version: 8.1Level: LLTClassification code 10037153

Registration Number: EUCTR2005-002141-39-DE

Lead Sponsor: CB Pharma S.A.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 150

Inclusion Criteria

1. Adult men and women > 18 years
2. Chronic plaque psoriasis that have been stable for at least 3 months and that
have been moderate to severe for at least 6 months
3. PASI =12 and BSA =10%
4. Candidates for systemic psoriasis therapy and/or phototherapy and/or chemophototherapy
5. Subject able to understand the information provided to them and to give written informed consent for CDP870-040
6. Female subject either postmenopausal for at least one year, surgically incapable
of childbearing, or effectively practising an acceptable method of contraception (oral or parenteral hormonal contraceptives; intrauterine device; barrier and spermicide. Abstinence is not an acceptable method). Subjects must agree to continue to use adequate contraception during the study and for 12 weeks after the last dose of CDP870.

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
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Erythrodermic, guttate, palmar or plantar, generalised pustular form of psoriasis
2. Infections
3. Positive hepatitis B surface antigen test and/or hepatitis C antibody test results
4. Positive human immunodeficiency virus (HIV) test result
5. Severe, progressive, and/or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurological or cerebral disease
6. Hepatic or renal dysfunction measured by hepatic enzymes (AST and ALT) greater than three times the upper limit of normal or seric creatinine higher than 2mg/100ml
7. Pregnancy and lactating female
8. White blood cell counts less than 4000/mm³ or more than 20000/mm³
9. New York Heart Association (NYHA) class III-IV congestive heart failure
10. Systemic Lupus
11. History of significant adverse reaction to biological products or polyethylene glycol
12. History of tuberculosis