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

UCB

Status and phase: Completed; Phase 2

Conditions: Chronic Plaque Psoriasis

Treatments: Other: Placebo; Drug: Certolizumab Pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT00245765

C87040

2005-002141-39 (EudraCT Number)

Details and patient eligibility

About

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.

Enrollment: 176 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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176 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Subcutaneous injections of Placebo every 2 weeks

Treatment:

Other: Placebo

Certolizumab Pegol 200 mg

Experimental group

Description:

Subcutaneous injections of 400 mg initial dose at week 0 with 200 mg every 2 weeks thereafter

Treatment:

Drug: Certolizumab Pegol

Certolizumab Pegol 400 mg

Experimental group

Description:

Subcutaneous injections of 400 mg every 2 weeks

Treatment:

Drug: Certolizumab Pegol