Completed
PHASE2, PHASE3
INTERVENTIONAL
NCT03051217
A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis
View on ClinicalTrials.gov
Updated Dec 15, 2025
Brief Summary
The purpose of this study is to demonstrate the efficacy and safety of Certolizumab Pegol (CZP) in the treatment of moderate to severe chronic plaque Psoriasis (PSO) in Japanese subjects.
Interventions
Name:
Placebo
Type:
OTHER
Description:
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 0.9 % saline
* Route of Administration: Subcutaneous use Q2W
Name:
Certolizumab Pegol
Type:
DRUG
Description:
* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Concentration: 200 mg/mL
* Route of Administration: Subcutaneous use
Primary Outcomes
Measure:
Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16
TimeFrame:
Week 16
Description:
The PASI75 response assessments were based on at least 75 % improvement in the PASI score from Baseline. This is a scoring system that averages the redness, thickness, and scaliness of the psoriatic lesions (on a 0-4 scale), and weights the resulting score by the area of skin involved. Body divided into 4 areas: head, arms, trunk to groin, and legs to top of buttocks. Assignment of an average score for the redness, thickness, and scaling for each of the 4 body areas with a score of 0 (clear) to 4 (very marked). Determining the percentage of skin covered with PSO for each of the body areas and converting to a 0 to 6 scale. Final PASI= average redness, thickness, and scaliness of the psoriatic skin lesions, multiplied by the involved psoriasis area score of the respective section, and weighted by the percentage of the person's affected skin for the respective section. The minimum possible PASI score is 0= no disease, the maximum score is 72= maximal disease.
Trial Information
NCT ID
NCT03051217
Status
Completed
Study Type
INTERVENTIONAL
Phases
PHASE2, PHASE3
Sponsor
UCB Biopharma S.P.R.L.
Last Updated
December 15, 2025