NCT04123795CompletedPhase 3
A Study to Evaluate the Pharmacokinetics, Safety, and Effectiveness of Certolizumab Pegol in Children With Moderate to Severe Chronic Plaque Psoriasis
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
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 49 (actual)
- First submitted
- 9 Oct 2019
- Start date
- 21 Jan 2020
- Primary completion date
- 9 Apr 2026
- Lead sponsor
- UCB Biopharma SRL
- Diseases
- Psoriasis
- NCT number
- NCT04123795
What you commit to
- Study type: Interventional · Phase 3
- Participants enrolled: 49
- From 21 Jan 2020 to the primary completion date, 9 Apr 2026
- 19 sites in 3 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Study participant previously participated in this study or has previously been treated with certolizumab pegol (CZP)
- Study participant has had prior exposure to \>2 biologic therapies
Other illness
- Study participant has had a primary failure to an anti-tumor necrosis factor agent
- 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
Other
- Study participant has generalized pustular or erythrodermic psoriasis (PSO)
- Study participant has guttate PSO without plaque PSO
Who the study is looking for
- Study participant must have a diagnosis of moderate to severe plaque psoriasis (PSO) for ≥3 months and:
- Body Surface Area (BSA) affected by psoriasis ≥10 %
- Physician's Global Assessment (PGA) score ≥3 (on a scale from 0 to 4)
- Psoriasis Area and Severity Index (PASI) score is ≥12 or
- 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
Age in the registry: 6 years to 17 years · Sex: All · Does not accept healthy volunteers
Sites (19)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Ps0007 50225 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ps0007 50183 Coordinator of this site? Confirm its status | Calgary | Canada | Unknown status |
| Ps0007 50187 Coordinator of this site? Confirm its status | Edmonton | Canada | Unknown status |
| Ps0007 50265 Coordinator of this site? Confirm its status | San Juan | Puerto Rico | Unknown status |
| Ps0007 50156 Coordinator of this site? Confirm its status | Arlington | United States | Unknown status |
| Ps0007 50217 Coordinator of this site? Confirm its status | Boca Raton | United States | Unknown status |
| Ps0007 50168 Coordinator of this site? Confirm its status | Chicago | United States | Unknown status |
| Ps0007 50232 Coordinator of this site? Confirm its status | Detroit | United States | Unknown status |
| Ps0007 50162 Coordinator of this site? Confirm its status | Fountain Valley | United States | Unknown status |
| Ps0007 50248 Coordinator of this site? Confirm its status | Hialeah | United States | Unknown status |
| Ps0007 50169 Coordinator of this site? Confirm its status | Jacksonville | United States | Unknown status |
| Ps0007 50161 Coordinator of this site? Confirm its status | Los Angeles | United States | Unknown status |
| Ps0007 50268 Coordinator of this site? Confirm its status | Miami | United States | Unknown status |
| Ps0007 50175 Coordinator of this site? Confirm its status | Phoenix | United States | Unknown status |
| Ps0007 50230 Coordinator of this site? Confirm its status | Rome | United States | Unknown status |
| Ps0007 50277 Coordinator of this site? Confirm its status | San Antonio | United States | Unknown status |
| Ps0007 50196 Coordinator of this site? Confirm its status | Thousand Oaks | United States | Unknown status |
| Ps0007 50286 Coordinator of this site? Confirm its status | Topeka | United States | Unknown status |
| Ps0007 50269 Coordinator of this site? Confirm its status | Wellington | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.