A Study to Evaluate the Efficacy, Safety, and Drug Concentration of Certolizumab Pegol (CZP) in Children and Adolescent Study Participants With Moderate to Severe Chronic Plaque Psoriasis (PSO)

Study Purpose

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.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 6 Years - 17 Years
Gender All
More Inclusion & Exclusion Criteria

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

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT04123795
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 3
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

UCB Biopharma SRL
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

UCB Cares
Principal Investigator Affiliation 001 844 599 2273 (UCB)
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Recruiting
Countries Canada, Puerto Rico, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Moderate Chronic Plaque Psoriasis, Severe Chronic Plaque Psoriasis, Mixed Guttate/Plaque Psoriasis
Arms & Interventions

Arms

Experimental: 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 and through the subsequent 104-Week Open-Label Extension Period.

Placebo Comparator: Cohort A - placebo

Enrolling study participants aged 12 to 17 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of placebo from Week 1 to 16 and certolizumab pegol to Week 52 and through the subsequent 104-Week Open-Label Extension Period.

Experimental: Cohort B - certolizumab pegol

Enrolling study participants aged 6 to 11 years (inclusive). Study participants in this arm will receive weight-based subcutaneous doses of certolizumab pegol from Week 1 to Week 52 and through the subsequent 104-Week Open-Label Extension Period.

Interventions

Drug: - Certolizumab pegol

Certolizumab Pegol Pharmaceutical Form: Solution for injection in pre-filled syringe Route of Administration: Subcutaneous use Other Names: Cimzia CDP870 CZP

Drug: - Placebo

Placebo Pharmaceutical Form: Solution for injection in pre-filled syringe Route of Administration: Subcutaneous use Other Names: -PBO

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Ps0007 50214, Auburn, Alabama

Status

Withdrawn

Address

Ps0007 50214

Auburn, Alabama, 36832

Ps0007 50175, Phoenix, Arizona

Status

Recruiting

Address

Ps0007 50175

Phoenix, Arizona, 85006

Ps0007 50213, Anaheim, California

Status

Withdrawn

Address

Ps0007 50213

Anaheim, California, 92804

Ps0007 50162, Fountain Valley, California

Status

Recruiting

Address

Ps0007 50162

Fountain Valley, California, 92708

Ps0007 50161, Los Angeles, California

Status

Recruiting

Address

Ps0007 50161

Los Angeles, California, 90045

Ps0007 50196, Thousand Oaks, California

Status

Recruiting

Address

Ps0007 50196

Thousand Oaks, California, 91320

Ps0007 50312, Aurora, Colorado

Status

Recruiting

Address

Ps0007 50312

Aurora, Colorado, 80012

Ps0007 50217, Boca Raton, Florida

Status

Recruiting

Address

Ps0007 50217

Boca Raton, Florida, 66215

Ps0007 50248, Hialeah, Florida

Status

Active, not recruiting

Address

Ps0007 50248

Hialeah, Florida, 33016

Ps0007 50169, Jacksonville, Florida

Status

Recruiting

Address

Ps0007 50169

Jacksonville, Florida, 32256

Ps0007 50318, Jacksonville, Florida

Status

Recruiting

Address

Ps0007 50318

Jacksonville, Florida, 32277

Ps0007 50268, Miami, Florida

Status

Recruiting

Address

Ps0007 50268

Miami, Florida, 33155

Ps0007 50216, Miami, Florida

Status

Recruiting

Address

Ps0007 50216

Miami, Florida, 33186

Ps0007 50246, Pembroke Pines, Florida

Status

Recruiting

Address

Ps0007 50246

Pembroke Pines, Florida, 33024

Ps0007 50184, Pembroke Pines, Florida

Status

Recruiting

Address

Ps0007 50184

Pembroke Pines, Florida, 33028

Ps0007 50269, Wellington, Florida

Status

Recruiting

Address

Ps0007 50269

Wellington, Florida, 33449

Ps0007 50230, Rome, Georgia

Status

Recruiting

Address

Ps0007 50230

Rome, Georgia, 30161

Ps0007 50274, Savannah, Georgia

Status

Recruiting

Address

Ps0007 50274

Savannah, Georgia, 31419

Ps0007 50168, Chicago, Illinois

Status

Recruiting

Address

Ps0007 50168

Chicago, Illinois, 60611

Ps0007 50222, Overland Park, Kansas

Status

Recruiting

Address

Ps0007 50222

Overland Park, Kansas, 66215

Ps0007 50286, Topeka, Kansas

Status

Recruiting

Address

Ps0007 50286

Topeka, Kansas, 66614

Ps0007 50188, Metairie, Louisiana

Status

Recruiting

Address

Ps0007 50188

Metairie, Louisiana, 70005

Ps0007 50158, Brighton, Massachusetts

Status

Recruiting

Address

Ps0007 50158

Brighton, Massachusetts, 02135

Ps0007 50178, Clarkston, Michigan

Status

Recruiting

Address

Ps0007 50178

Clarkston, Michigan, 48346

Ps0007 50232, Detroit, Michigan

Status

Recruiting

Address

Ps0007 50232

Detroit, Michigan, 48202

Ps0007 50186, Saint Joseph, Michigan

Status

Recruiting

Address

Ps0007 50186

Saint Joseph, Michigan, 49085

Ps0007 50105, Saint Louis, Missouri

Status

Active, not recruiting

Address

Ps0007 50105

Saint Louis, Missouri, 63110

Ps0007 50185, Lebanon, New Hampshire

Status

Recruiting

Address

Ps0007 50185

Lebanon, New Hampshire, 03756

Ps0007 50159, Portsmouth, New Hampshire

Status

Recruiting

Address

Ps0007 50159

Portsmouth, New Hampshire, 03801

Ps0007 50247, Bronx, New York

Status

Recruiting

Address

Ps0007 50247

Bronx, New York, 10468

Ps0007 50160, Forest Hills, New York

Status

Active, not recruiting

Address

Ps0007 50160

Forest Hills, New York, 11375

Ps0007 50229, Rocky Mount, North Carolina

Status

Recruiting

Address

Ps0007 50229

Rocky Mount, North Carolina, 27804

Ps0007 50326, Marion, Ohio

Status

Recruiting

Address

Ps0007 50326

Marion, Ohio, 43302

Ps0007 50212, Tulsa, Oklahoma

Status

Recruiting

Address

Ps0007 50212

Tulsa, Oklahoma, 74105

Ps0007 50150, Philadelphia, Pennsylvania

Status

Recruiting

Address

Ps0007 50150

Philadelphia, Pennsylvania, 19103

Ps0007 50157, Pittsburgh, Pennsylvania

Status

Recruiting

Address

Ps0007 50157

Pittsburgh, Pennsylvania, 15213

Ps0007 50156, Arlington, Texas

Status

Recruiting

Address

Ps0007 50156

Arlington, Texas, 76011

Ps0007 50226, Houston, Texas

Status

Recruiting

Address

Ps0007 50226

Houston, Texas, 77030

Ps0007 50281, Laredo, Texas

Status

Recruiting

Address

Ps0007 50281

Laredo, Texas, 78041

Ps0007 50277, San Antonio, Texas

Status

Recruiting

Address

Ps0007 50277

San Antonio, Texas, 78218

Ps0007 50227, Seattle, Washington

Status

Recruiting

Address

Ps0007 50227

Seattle, Washington, 98105

International Sites

Ps0007 50163, Calgary, Canada

Status

Recruiting

Address

Ps0007 50163

Calgary, ,

Ps0007 50183, Calgary, Canada

Status

Recruiting

Address

Ps0007 50183

Calgary, ,

Ps0007 50167, Montréal, Canada

Status

Recruiting

Address

Ps0007 50167

Montréal, ,

Ps0007 50225, Red Deer, Canada

Status

Recruiting

Address

Ps0007 50225

Red Deer, ,

Ps0007 50215, Saint John's, Canada

Status

Recruiting

Address

Ps0007 50215

Saint John's, ,

Ps0007 50231, Carolina, Puerto Rico

Status

Recruiting

Address

Ps0007 50231

Carolina, ,

Ps0007 50278, Ponce, Puerto Rico

Status

Recruiting

Address

Ps0007 50278

Ponce, ,

Ps0007 50265, San Juan, Puerto Rico

Status

Recruiting

Address

Ps0007 50265

San Juan, ,

The content provided on clinical trials is for informational purposes only and is not a substitute for medical consultation with your healthcare provider. We do not recommend or endorse any specific study and you are advised to discuss the information shown with your healthcare provider. While we believe the information presented on this website to be accurate at the time of writing, we do not guarantee that its contents are correct, complete, or applicable to any particular individual situation. We strongly encourage individuals to seek out appropriate medical advice and treatment from their physicians. We cannot guarantee the availability of any clinical trial listed and will not be responsible if you are considered ineligible to participate in a given clinical trial. We are also not liable for any injury arising as a result of participation.