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

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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

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

Trial contacts and locations

15

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Data sourced from clinicaltrials.gov

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