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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

Full criteria on ClinicalTrials.gov

Sites (19)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
Ps0007 50225
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Ps0007 50183
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Ps0007 50187
Coordinator of this site? Confirm its status
EdmontonCanadaUnknown status
Ps0007 50265
Coordinator of this site? Confirm its status
San JuanPuerto RicoUnknown status
Ps0007 50156
Coordinator of this site? Confirm its status
ArlingtonUnited StatesUnknown status
Ps0007 50217
Coordinator of this site? Confirm its status
Boca RatonUnited StatesUnknown status
Ps0007 50168
Coordinator of this site? Confirm its status
ChicagoUnited StatesUnknown status
Ps0007 50232
Coordinator of this site? Confirm its status
DetroitUnited StatesUnknown status
Ps0007 50162
Coordinator of this site? Confirm its status
Fountain ValleyUnited StatesUnknown status
Ps0007 50248
Coordinator of this site? Confirm its status
HialeahUnited StatesUnknown status
Ps0007 50169
Coordinator of this site? Confirm its status
JacksonvilleUnited StatesUnknown status
Ps0007 50161
Coordinator of this site? Confirm its status
Los AngelesUnited StatesUnknown status
Ps0007 50268
Coordinator of this site? Confirm its status
MiamiUnited StatesUnknown status
Ps0007 50175
Coordinator of this site? Confirm its status
PhoenixUnited StatesUnknown status
Ps0007 50230
Coordinator of this site? Confirm its status
RomeUnited StatesUnknown status
Ps0007 50277
Coordinator of this site? Confirm its status
San AntonioUnited StatesUnknown status
Ps0007 50196
Coordinator of this site? Confirm its status
Thousand OaksUnited StatesUnknown status
Ps0007 50286
Coordinator of this site? Confirm its status
TopekaUnited StatesUnknown status
Ps0007 50269
Coordinator of this site? Confirm its status
WellingtonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.