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 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 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 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

Site Contact

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