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

UCB

Status and phase: Completed; Phase 3; Phase 2

Conditions: Generalized Pustular Psoriasis and Erythrodermic Psoriasis; Moderate to Severe Psoriasis

Treatments: Other: Placebo; Drug: Certolizumab Pegol

Study type: Interventional

Funder types: Industry

Identifiers

NCT03051217

PS0017

Details and patient eligibility

About

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.

Enrollment: 127 patients

Sex: All

Ages: 20+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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127 participants in 3 patient groups, including a placebo group

Placebo

Placebo Comparator group

Description:

Placebo subcutaneous (sc) injection every two weeks (Q2W)

Treatment:

Other: Placebo

CZP 200 mg

Experimental group

Description:

Certolizumab Pegol subcutaneous (sc) injection 400 mg at Weeks 0, 2, 4, followed by Certolizumab Pegol subcutaneous (sc) injection 200 mg every two weeks (Q2W) with PBO administered to maintain the blind, starting at Week 6

Treatment:

Other: Placebo

Drug: Certolizumab Pegol

CZP 400 mg

Experimental group

Description:

Certolizumab Pegol subcutaneous (sc) injection 400 mg every two weeks (Q2W).

Treatment:

Drug: Certolizumab Pegol