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PS0007

Multicenter, Randomized, Parallel-Group, Double-Blind, Placebo-Controlled (12-17 Years) Including a Single Open-Label Arm (6-11 Years) Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Certolizumab Pegol (CZP) in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

Brief summary

The purpose of the study is to demonstrate the efficacy and safety of certolizumab pegol in the treatment of moderate to severe chronic plaque psoriasis in study participants aged 6 to 11 and 12 to 17 years.

Medical Condition

Moderate chronic plaque psoriasis

Min. Age

6
Years

Max. Age

17
Years

Who Can Join?

All

Status

Recruiting
Inclusion criteria
-Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and: 1. Body Surface Area (BSA) affected by psoriasis ≥10 % 2. Physician’s Global Assessment (PGA) score ≥3 (on a scale from 0 to 4) 3. Psoriasis Area and Severity Index (PASI) score is ≥12 or 4. PASI score is ≥10 and Clinically relevant facial or scalp involvement ->Clinically relevant genital involvement ->Clinically relevant palm and sole involvement ->Clinically relevant axillary involvement Study participants aged ≥12 years may alternatively have a diagnosis of moderate to severe mixed guttate/plaque PSO with >50 % to
Exclusion criteria
-Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP) -Study participant has generalized pustular or erythrodermic psoriasis (PSO) -Study participant has guttate PSO without plaque PSO -Study participant has had a primary failure to an anti-tumor necrosis factor agent -Study participant has had prior exposure to >2 biologic therapies -Study participant has a history of severe major depression or suicide attempt (including an actual attempt, interrupted attempt, or aborted attempt), or has had suicidal ideation in the past 6 months as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the “Screening/Baseline” version of the Columbia Suicide Severity Rating Scale (CSSRS) at Screening

Study Medication Description

Study Medication:

CIMZIA

Other Descriptive Name:

certolizumab pegol

Placebo

Yes

Comparator:

No

Study Dates

January 2020

Actual Start Date of Enrollment

December 2026

Planned Study Completion Date

General Information

Study ID:
PS0007
EudraCT Number:
2021-003371-33
CT.gov Number:
NCT04123795
Phase:
Phase 3

Interested in enrolling in our study?

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