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

• Register: ClinicalTrials.gov
• Last refreshed on: 12 December 2020
• Main ID: NCT00245765
• Date of registration: 26/10/2005
• Prospective Registration: No
• Primary sponsor: UCB Pharma
• Public title: Efficacy Study of CDP870 in Subjects With Chronic Plaque Psoriasis Who Are Candidate for Systemic Therapy and/or Phototherapy/Photochemotherapy
• Scientific title: Multicenter, Dose Response, Randomized, Double Blind, Parallel, Placebo Controlled Clinical Trial to Evaluate the Efficacy and the Safety of Subcutaneous CDP870 in Subjects Suffering From Moderate-to-severe Chronic Plaque Psoriasis Who Are Candidates for Systemic Therapy and/or Phototherapy and/or Photochemotherapy
• Date of first enrolment: October 2005
• Target sample size: 176
• Recruitment status: Completed
• URL: https://clinicaltrials.gov/show/NCT00245765
• Study type: Interventional
• Study design: Allocation: Randomized. Intervention model: Parallel Assignment. Primary purpose: Treatment. Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor).
• Phase: Phase 2

Countries of recruitment

France, Germany

Contacts

• Name: UCB Clinical Trial Call Center
• Affiliation: UCB Pharma

Key inclusion & exclusion 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



Age minimum: 18 Years
Age maximum: N/A
Gender: All

Health Condition(s) or Problem(s) studied

Chronic Plaque Psoriasis

Intervention(s)

Drug: Certolizumab Pegol

Other: Placebo

Primary Outcome(s)

Achievement of Psoriasis Activity and Severity Index (PASI75) Response at Week 12 [Time Frame: Week 12]

Achievement of a Physician's Global Assessment (PGA) of Clear or Almost Clear at Week 12 [Time Frame: Week 12]

Secondary Outcome(s)

Achievement of a Psoriasis Activity and Severity Index (PASI90) Response at Week 12 [Time Frame: Week 12]

Experience of a Rebound Effect Within 2 Months After Stopping Therapy [Time Frame: Within 2 months of stopping therapy]

Time to Psoriasis Activity and Severity Index 75 (PASI75) [Time Frame: During the 12-weeks Treatment Period]

Time to Discontinuation From the Treatment Period Due to Lack of Efficacy or Worsening of Psoriasis [Time Frame: During the 12-week Treatment Period]

Achievement of a Psoriasis Activity and Severity Index (PASI50) Response at Week 12 [Time Frame: Week 12]

Time to Relapse [Time Frame: During the 12-weeks Treatment Period]

Absolute Change From Baseline in the Body Surface Area (BSA) Affected by Psoriasis at Week 12 [Time Frame: Baseline up to Week 12]

Time to Psoriasis Activity and Severity Index 50 (PASI50) [Time Frame: During the 12-weeks Treatment Period]

Percent of Body Surface Area (BSA) Affected by Psoriasis at Week 12 [Time Frame: Week 12]

Secondary ID(s)

C87040

2005-002141-39

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Results

• Results available: Yes
• Date Posted: 03/05/2019
• URL: https://clinicaltrials.gov/ct2/show/results/NCT00245765