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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2005-002141-39-DE

Enrollment

150

Registered

2005-09-01

Start date

2005-10-25

Completion date

Unknown

Last updated

2012-03-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis MedDRA version: 8.1 Level: LLT Classification code 10037153

Interventions

Product Code: CDP870 Pharmaceutical Form: Solution for injection INN or Proposed INN: Certolizumab pegol (rINN) Current Sponsor code: CDP870 Concentration unit: mg milligram(s) Concentration type: equ

Eligibility

Sex/Gender

All

Inclusion criteria

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

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

Design outcomes

Primary

Measure	Time frame
Main Objective: To assess the efficacy, versus placebo, of fortnightly doses of CDP870 (200mg and 400mg) administered subcutaneously in subjects with moderate to severe psoriasis as measured by the proportion of subjects achieving =75% decrease from baseline in the Psoriasis Area and Severity Index score (PASI75) and the proportion of subjects with a Psoriasis Global Assessment (PGA) rating ‘Clear’ or ‘Almost Clear’ at the end of the 12 week treatment period.;Secondary Objective: 1. To assess the safety and tolerability of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo. 2. To assess the efficacy of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo as measured by: • the time to onset of action, defined as the time to first =50% decrease and the time to first =75% decrease from baseline in PASI during the treatment period • the time to relapse after the 12 week treatment period • the proportion of subjects experiencing rebound during the 2 first months of follow-up • the change from baseline in the body surface area (BSA) affected by psoriasis at the end of the 12 week treatment period • the proportion of subjects achieving =90% decrease from baseline in PASI (PASI90) at the end of the 12 week treatment period • the proportion of subjects achieving =50% decrease from baseline in PASI (PASI50) at the end of the 12 week treatment period ;Primary end point(s): The co-primary efficacy variables are the proportion of subjects achieving =75% decrease from baseline in the Psoriasis Area and Severity Index score (PASI75) and the proportion of subjects with a Psoriasis Global Assessment (PGA) rating ‘Clear’ or ‘Almost Clear’ at the end of the 12 week treatment period. The study will be declared successful if at least one of the two dose comparisons to placebo is statistically significant for both the PASI and the PGA endpoints.	—

Measure

Time frame

Main Objective: To assess the efficacy, versus placebo, of fortnightly doses of CDP870 (200mg and 400mg) administered subcutaneously in subjects with moderate to severe psoriasis as measured by the proportion of subjects achieving =75% decrease from baseline in the Psoriasis Area and Severity Index score (PASI75) and the proportion of subjects with a Psoriasis Global Assessment (PGA) rating ‘Clear’ or ‘Almost Clear’ at the end of the 12 week treatment period.;Secondary Objective: 1. To assess the safety and tolerability of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo. 2. To assess the efficacy of the different dose regimens of CDP870 administered subcutaneously for 12 weeks versus placebo as measured by: • the time to onset of action, defined as the time to first =50% decrease and the time to first =75% decrease from baseline in PASI during the treatment period • the time to relapse after the 12 week treatment period • the proportion of subjects experiencing rebound during the 2 first months of follow-up • the change from baseline in the body surface area (BSA) affected by psoriasis at the end of the 12 week treatment period • the proportion of subjects achieving =90% decrease from baseline in PASI (PASI90) at the end of the 12 week treatment period • the proportion of subjects achieving =50% decrease from baseline in PASI (PASI50) at the end of the 12 week treatment period ;Primary end point(s): The co-primary efficacy variables are the proportion of subjects achieving =75% decrease from baseline in the Psoriasis Area and Severity Index score (PASI75) and the proportion of subjects with a Psoriasis Global Assessment (PGA) rating ‘Clear’ or ‘Almost Clear’ at the end of the 12 week treatment period. The study will be declared successful if at least one of the two dose comparisons to placebo is statistically significant for both the PASI and the PGA endpoints.

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Countries

Germany

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026