A Study to Test the Efficacy and Safety of Certolizumab Pegol in Japanese Subjects With Moderate to Severe Chronic Psoriasis

UCB Biopharma S.P.R.L.127 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

127

Conditions

Moderate to Severe Psoriasis Generalized Pustular Psoriasis and Erythrodermic Psoriasis

Interventions

PlaceboOTHER

* Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 0.9 % saline * Route of Administration: Subcutaneous use Q2W

Certolizumab PegolDRUG

* Pharmaceutical Form: Solution for injection in pre-filled syringe * Concentration: 200 mg/mL * Route of Administration: Subcutaneous use

Eligibility

Sex: ALLMin age: 20 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Subject is male or female, \>= 20 years of age. * Institutional Review Board-approved written informed consent form is signed and dated by the subject. * Other protocol-defined inclusion criteria may apply. For subjects with moderate to severe chronic plaque psoriasis (PSO) * Chronic plaque psoriasis for at least 6 months. * Baseline Psoriasis Activity and Severity Index (PASI) \>=12 and Body Surface Area (BSA) affected by PSO \>=10% and Physician's Global Assessment (PGA) score of 3 or higher. * Candidates for systemic PSO therapy and/or phototherapy and/or chemophototherapy. For subjects with generalized pustular PSO or erythrodermic PSO * Diagnosis of generalized pustular PSO or erythrodermic PSO at Screening. * History of plaque-type PSO if subjects have a diagnosis of erythrodermic PSO. * Baseline BSA affected by PSO \>=80% if subjects have a diagnosis of erythrodermic PSO. Exclusion Criteria: * Female subject who is breastfeeding, pregnant, or plans to become pregnant during the study or within 5 months following last dose of study drug. Male subject who is planning a partner pregnancy during the study or within 5 months following the last dose of study drug. * Subject has guttate psoriasis or drug-induced psoriasis. For subjects with moderate to severe plaque psoriasis, erythrodermic or pustular forms of psoriasis also are excluded. * History of current, chronic, or recurrent infections of viral, bacterial, or fungal origin as described in the protocol. Also, subjects with a high risk of infection in the Investigator's opinion. * History of a lymphoproliferative disorder including lymphoma or current signs and symptoms suggestive of lymphoproliferative disease. * History of other malignancy or concurrent malignancy as described in the protocol. * Class III or IV congestive heart failure * History of, or suspected, demyelinating disease of the central nervous system (e.g., multiple sclerosis or optic neuritis). * Subject has any other condition which, in the Investigator's judgment, would make the subject unsuitable for inclusion in the study. * Concurrent medication restrictions as described in the protocol. * Subject with known tuberculosis (TB) infection, at high risk of acquiring TB infection, or with untreated latent tuberculosis infection (LTBI) or current or history of nontuberculous mycobacterial (NTMB) infection. * Subject has any protocol defined clinically significant laboratory abnormalities at the screening * Other protocol-defined exclusion criteria may apply.

Locations (33)

Ps0017 024

Asahikawa, Japan

Outcomes

Primary Outcomes

Percentage of Subjects Achieving a 75 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

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.

Time frame: Week 16

Secondary Outcomes

Percentage of Subjects Who Achieve a Physician's Global Assessment (PGA) Clear or Almost Clear Response (With at Least 2-category Improvement) at Week 16

This Outcome Measure applied to participants with moderate to severe chronic plaque Psoriasis (PSO). The Investigator assessed the overall severity of Psoriasis (PSO) using the following 5-point scale: 0=clear, 1=almost clear, 2=mild, 3=moderate, 4=severe.

Time frame: Week 16

Percentage of Subjects Achieving a 90 % or Higher Improvement in Psoriasis Area and Severity Index (PASI) Score at Week 16

The PASI90 response assessments were based on at least 90 % 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.

Data from ClinicalTrials.gov

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