RECRUITING

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

Conditions

Moderate Chronic Plaque Psoriasis Severe Chronic Plaque Psoriasis Mixed Guttate/Plaque Psoriasis Chronic plaque psoriasis Certolizumab pegol Cimzia Pediatric study Phase 3

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

Multicenter, Open Label or Double-Blind, Placebo-Controlled Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Pediatric Study Participants With Moderate to Severe Chronic Plaque Psoriasis

Quick Facts

Study Start:2020-01-21

Study Completion:2034-08-15

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04123795

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:6 Years to 17 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Study Contact

UCB Cares

CONTACT

0018445992273

UCBCares@ucb.com

Principal Investigator

UCB Cares

STUDY_DIRECTOR

001 844 599 2273 (UCB)

Study Locations (Sites)

Ps0007 50214

Auburn, Alabama, 36832

United States

Ps0007 50175

Phoenix, Arizona, 85006

United States

Ps0007 50213

Anaheim, California, 92804

United States

Ps0007 50162

Fountain Valley, California, 92708

United States

Ps0007 50161

Los Angeles, California, 90045

United States

Ps0007 50196

Thousand Oaks, California, 91320

United States

Ps0007 50312

Aurora, Colorado, 80012

United States

Ps0007 50217

Boca Raton, Florida, 33428

United States

Ps0007 50248

Hialeah, Florida, 33016

United States

Ps0007 50169

Jacksonville, Florida, 32256

United States

Ps0007 50318

Jacksonville, Florida, 32277

United States

Ps0007 50268

Miami, Florida, 33155

United States

Ps0007 50216

Miami, Florida, 33186

United States

Ps0007 50246

Pembroke Pines, Florida, 33024

United States

Ps0007 50184

Pembroke Pines, Florida, 33028

United States

Ps0007 50269

Wellington, Florida, 33449

United States

Ps0007 50230

Rome, Georgia, 30161

United States

Ps0007 50274

Savannah, Georgia, 31419

United States

Ps0007 50168

Chicago, Illinois, 60611

United States

Ps0007 50222

Overland Park, Kansas, 66210

United States

Ps0007 50286

Topeka, Kansas, 66614

United States

Ps0007 50188

Metairie, Louisiana, 70005

United States

Ps0007 50158

Brighton, Massachusetts, 02135

United States

Ps0007 50178

Clarkston, Michigan, 48346

United States

Ps0007 50232

Detroit, Michigan, 48202

United States

Ps0007 50186

Saint Joseph, Michigan, 49085

United States

Ps0007 50105

Saint Louis, Missouri, 63110

United States

Ps0007 50185

Lebanon, New Hampshire, 03756

United States

Ps0007 50159

Portsmouth, New Hampshire, 03801

United States

Ps0007 50247

Bronx, New York, 10468

United States

Ps0007 50160

Forest Hills, New York, 11375

United States

Ps0007 50229

Rocky Mount, North Carolina, 27804

United States

Ps0007 50326

Marion, Ohio, 43302

United States

Ps0007 50212

Tulsa, Oklahoma, 74135

United States

Ps0007 50150

Philadelphia, Pennsylvania, 19103

United States

Ps0007 50157

Pittsburgh, Pennsylvania, 15213

United States

Ps0007 50156

Arlington, Texas, 76011

United States

Ps0007 50226

Houston, Texas, 77030

United States

Ps0007 50281

Laredo, Texas, 78041

United States

Ps0007 50277

San Antonio, Texas, 78218

United States

Ps0007 50227

Seattle, Washington, 98105

United States

Collaborators and Investigators

Sponsor: UCB Biopharma SRL

UCB Cares, STUDY_DIRECTOR, 001 844 599 2273 (UCB)

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2020-01-21

Study Completion Date2034-08-15

Study Record Updates

Study Start Date2020-01-21

Study Completion Date2034-08-15

Terms related to this study

Keywords Provided by Researchers

Chronic plaque psoriasis
Certolizumab pegol
Cimzia
Pediatric study
Phase 3

Additional Relevant MeSH Terms

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