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A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis

NCT ID: NCT04123795

Last Updated: 2025-11-10

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE3

Total Enrollment

150 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-01-21

Study Completion Date

2034-08-15

Brief Summary

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The purpose of the study is to evaluate the pharmacokinetic (PK) of certolizumab pegol (CZP) in study participants aged 6 to 17 years with moderate to severe chronic plaque psoriasis (PSO) in order to support extrapolation of efficacy.

Detailed Description

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Conditions

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Moderate Chronic Plaque Psoriasis Severe Chronic Plaque Psoriasis Mixed Guttate/Plaque Psoriasis

Keywords

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Chronic plaque psoriasis Certolizumab pegol Cimzia Pediatric study Phase 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Cohort A - certolizumab pegol

Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Active Treatment period and through the subsequent Open-Label Extension Period.

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type DRUG

Certolizumab Pegol

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Cohort A - placebo

Enrolling study participants aged 12 to 17 years (inclusive) under Amendment 4 and earlier. Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to Week 16 of the Active Treatment period.

Group Type PLACEBO_COMPARATOR

Certolizumab pegol

Intervention Type DRUG

Certolizumab Pegol

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Placebo

Intervention Type DRUG

Placebo

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Cohort B - certolizumab pegol - Open-label

Enrolling study participants aged 6 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 of the Open-label Period and through the subsequent Open-Label Extension Period.

Group Type EXPERIMENTAL

Certolizumab pegol

Intervention Type DRUG

Certolizumab Pegol

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Interventions

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Certolizumab pegol

Certolizumab Pegol

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Intervention Type DRUG

Placebo

Placebo

* Pharmaceutical Form: Solution for injection in pre-filled syringe
* Route of Administration: Subcutaneous use

Intervention Type DRUG

Other Intervention Names

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-Cimzia -CDP870 -CZP

Eligibility Criteria

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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 \<12 with at least one of the following:
* \>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 \<80 % guttate lesions for ≥3 months, and must meet the same criteria listed above
* Study participant must be a candidate for systemic psoriasis therapy and/or phototherapy and/or photochemotherapy

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
Minimum Eligible Age

6 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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UCB Biopharma SRL

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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UCB Cares

Role: STUDY_DIRECTOR

001 844 599 2273 (UCB)

Locations

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Ps0007 50214

Auburn, Alabama, United States

Site Status WITHDRAWN

Ps0007 50175

Phoenix, Arizona, United States

Site Status COMPLETED

Ps0007 50213

Anaheim, California, United States

Site Status WITHDRAWN

Ps0007 50162

Fountain Valley, California, United States

Site Status RECRUITING

Ps0007 50161

Los Angeles, California, United States

Site Status RECRUITING

Ps0007 50196

Thousand Oaks, California, United States

Site Status RECRUITING

Ps0007 50312

Aurora, Colorado, United States

Site Status WITHDRAWN

Ps0007 50217

Boca Raton, Florida, United States

Site Status RECRUITING

Ps0007 50248

Hialeah, Florida, United States

Site Status RECRUITING

Ps0007 50169

Jacksonville, Florida, United States

Site Status RECRUITING

Ps0007 50318

Jacksonville, Florida, United States

Site Status WITHDRAWN

Ps0007 50268

Miami, Florida, United States

Site Status RECRUITING

Ps0007 50216

Miami, Florida, United States

Site Status WITHDRAWN

Ps0007 50246

Pembroke Pines, Florida, United States

Site Status RECRUITING

Ps0007 50184

Pembroke Pines, Florida, United States

Site Status WITHDRAWN

Ps0007 50269

Wellington, Florida, United States

Site Status COMPLETED

Ps0007 50230

Rome, Georgia, United States

Site Status COMPLETED

Ps0007 50274

Savannah, Georgia, United States

Site Status WITHDRAWN

Ps0007 50168

Chicago, Illinois, United States

Site Status RECRUITING

Ps0007 50222

Overland Park, Kansas, United States

Site Status WITHDRAWN

Ps0007 50286

Topeka, Kansas, United States

Site Status COMPLETED

Ps0007 50188

Metairie, Louisiana, United States

Site Status WITHDRAWN

Ps0007 50158

Brighton, Massachusetts, United States

Site Status RECRUITING

Ps0007 50178

Clarkston, Michigan, United States

Site Status RECRUITING

Ps0007 50232

Detroit, Michigan, United States

Site Status RECRUITING

Ps0007 50186

Saint Joseph, Michigan, United States

Site Status RECRUITING

Ps0007 50105

St Louis, Missouri, United States

Site Status WITHDRAWN

Ps0007 50185

Lebanon, New Hampshire, United States

Site Status WITHDRAWN

Ps0007 50159

Portsmouth, New Hampshire, United States

Site Status WITHDRAWN

Ps0007 50160

Forest Hills, New York, United States

Site Status WITHDRAWN

Ps0007 50247

The Bronx, New York, United States

Site Status WITHDRAWN

Ps0007 50229

Rocky Mount, North Carolina, United States

Site Status WITHDRAWN

Ps0007 50326

Marion, Ohio, United States

Site Status WITHDRAWN

Ps0007 50212

Tulsa, Oklahoma, United States

Site Status WITHDRAWN

Ps0007 50150

Philadelphia, Pennsylvania, United States

Site Status RECRUITING

Ps0007 50157

Pittsburgh, Pennsylvania, United States

Site Status WITHDRAWN

Ps0007 50156

Arlington, Texas, United States

Site Status COMPLETED

Ps0007 50226

Houston, Texas, United States

Site Status WITHDRAWN

Ps0007 50281

Laredo, Texas, United States

Site Status WITHDRAWN

Ps0007 50277

San Antonio, Texas, United States

Site Status RECRUITING

Ps0007 50227

Seattle, Washington, United States

Site Status WITHDRAWN

Ps0007 50163

Calgary, , Canada

Site Status WITHDRAWN

Ps0007 50183

Calgary, , Canada

Site Status RECRUITING

Ps0007 50225

Calgary, , Canada

Site Status ACTIVE_NOT_RECRUITING

Ps0007 50187

Edmonton, , Canada

Site Status RECRUITING

Ps0007 50167

Montreal, , Canada

Site Status WITHDRAWN

Ps0007 50215

St. John's, , Canada

Site Status RECRUITING

Ps0007 50279

Vancouver, , Canada

Site Status WITHDRAWN

Ps0007 50231

Carolina, , Puerto Rico

Site Status RECRUITING

Ps0007 50278

Ponce, , Puerto Rico

Site Status WITHDRAWN

Ps0007 50265

San Juan, , Puerto Rico

Site Status RECRUITING

Countries

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United States Canada Puerto Rico

Central Contacts

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UCB Cares

Role: CONTACT

Phone: 0018445992273

Email: [email protected]

Other Identifiers

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PS0007

Identifier Type: -

Identifier Source: org_study_id