Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy

• Status: Completed
• Trial end date: 2006-11-01
• Target enrollment: 0
• Participant gender: All

Summary

A study to assess the safety and efficacy of 2 different doses of CDP870 versus placebo, administered during 12 weeks, to patients suffering from moderate to severe chronic plaque psoriasis, extended by a 12 to 24 week follow-up.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: UCB Pharma
• Treatments: Certolizumab Pegol

Criteria

Inclusion Criteria:

• Adult men and women > 18 years

• Subjects with chronic plaque psoriasis stable for at least 3 months and moderate to severe for at least 6 months

• Subjects with Psoriasis Area and Severity Index (PASI) ≥ 12 and Body Surface Area (BSA) ≥ 10 %

• Subjects were candidates for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

Exclusion Criteria:

• Subjects with an erythrodermic, guttate, palmar or plantar, generalized pustular form of psoriasis

• A history of chronic infection, recent serious or life-threatening infection (within six months, including herpes zoster), or any current sign or symptom that may indicate an infection (e.g. fever, cough);

• White blood cell counts less than 4000/mm^3 or more than 20000/mm^3

• Suspected or diagnosed demyelinating disease of the central nervous system (e.g. multiple sclerosis or optic neuritis)

• Systemic Lupus

• Non respect of adequate wash out periods for treatments that might have an impact on the disease

• Any associated disease that could be impacted by the study treatment intake

• Any other condition, which in the Investigator's judgment would make the subject unsuitable for inclusion in the study