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NCT04718896CompletedPhase 2

A Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis

A Multicenter, Open-Label, Randomized Study to Assess the Pharmacokinetics, Safety, and Efficacy of Two Doses of Bimekizumab in Adolescent Study Participants With Moderate to Severe Plaque Psoriasis

Source: ClinicalTrials.gov · Last updated 3 Aug 2026

Brief summary (registry, in English)

The purpose of the study is to assess th pharmacokinetics (PK) of bimekizumab administered subcutaneously (sc) in adolescents with moderate to severe plaque psoriasis (PSO).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
41 (actual)
First submitted
18 Jan 2021
Start date
6 Apr 2021
Primary completion date
12 Mar 2025
Lead sponsor
UCB Biopharma SRL
Diseases
Psoriasis
NCT number
NCT04718896
EU CT number
2023-509832-24-00
EudraCT number
2020-001724-34

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 41
  • From 6 Apr 2021 to the primary completion date, 12 Mar 2025
  • 11 sites in 4 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.

Other illness

  • Participant has a presence of guttate, inverse, pustular, or erythrodermic PSO or other dermatological condition that may impact the clinical assessment of PSO
  • Participant has a history of inflammatory bowel disease (IBD) or symptoms suggestive of IBD
  • History of active tuberculosis unless successfully treated, latent TB unless prophylactically treated
  • Participant has an active infection or history of infections (such as serious infection, chronic infections, opportunistic infections, unusually severe infections)
  • Participant has experienced primary failure to one or more interleukin-17 (IL-17) biologic response modifier OR primary failure to more than 1 biologic response modifier other than an IL-17 biologic response modifier

Lab values

  • Participant has laboratory abnormalities at Screening

Other

  • Presence of active suicidal ideation, or positive suicide behavior
  • Participant has been diagnosed with severe depression in the past 6 months

Who the study is looking for

  • Participant must be ≥12 to less than 18 years of age at the time of signing the informed consent/assent according to local regulation
  • Participant has had a diagnosis of moderate to severe plaque psoriasis (PSO) for at least 3 months prior to the Screening Visit and:
    • Body surface area (BSA) affected by PSO ≥10%
    • Investigator's Global Assessment (IGA) score ≥3 (on a scale from 0 to 4)
    • Psoriasis Area and Severity Index (PASI) score ≥12 OR
    • PASI score ≥10 plus at least 1 of the following:
    • Clinically relevant facial involvement ii. Clinically relevant genital involvement iii. Clinically relevant hand and foot involvement
  • Participant must be candidate for systemic PSO therapy and/or photo/chemotherapy
  • Body weight ≥30 kg and body mass index for age percentile of ≥5 at Baseline
  • Male or female A female participant will be eligible to participate if she is not pregnant, not breastfeeding, and a woman of childbearing potential (WOCBP) agrees to follow the contraceptive guidance
  • Capable of giving/having parent(s) or legal representative provide signed informed consent/assent (where appropriate)

Age in the registry: 12 years to 17 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (11)

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

SiteCityCountrySite status
Ps0020 50354
Coordinator of this site? Confirm its status
CalgaryCanadaUnknown status
Ps0020 50357
Coordinator of this site? Confirm its status
St. John'sCanadaUnknown status
Universitaetsklinikum Frankfurt AöR
Coordinator of this site? Confirm its status
Frankfurt Am MainGermanyCompleted
Specderm Poznanska sp.j.
Coordinator of this site? Confirm its status
BialystokPolandCompleted
DERMED Centrum Medyczne Sp. z o.o.
Coordinator of this site? Confirm its status
LodzPolandCompleted
Uniwersytecki Szpital Kliniczny Im. Fryderyka Chopina W Rzeszowie
Coordinator of this site? Confirm its status
RzeszówPolandCompleted
Panstwowy Instytut Medyczny Ministerstwa Spraw Wewnetrznych i Administracji
Coordinator of this site? Confirm its status
WarsawPolandCompleted
Cityclinic Przychodnia lekarsko psychologiczna Matusiak sp.p
Coordinator of this site? Confirm its status
WroclawPolandCompleted
dermMedica Sp. z o.o
Coordinator of this site? Confirm its status
WroclawPolandCompleted
Ps0020 50359
Coordinator of this site? Confirm its status
CypressUnited StatesUnknown status
Ps0020 50344
Coordinator of this site? Confirm its status
IndianapolisUnited StatesUnknown status

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