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NCT04083612CompletedPhase 4

Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients

Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Ixekizumab and the Development of Concentration-response Curve of Ixekizumab for Psoriasis Patients

Source: ClinicalTrials.gov · Last updated 19 Sept 2024

Brief summary (registry, in English)

Biologics, such as ixekizumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab in psoriasis patients.

Status (registry)
Completed
Phase (registry)
Phase 4
Study type
Interventional
Enrollment
49 (actual)
First submitted
19 Jul 2019
Start date
4 May 2020
Primary completion date
31 Dec 2023
Lead sponsor
University Hospital, Ghent
Diseases
Psoriasis
NCT number
NCT04083612

What you commit to

  • Study type: Interventional · Phase 4
  • Participants enrolled: 49
  • From 4 May 2020 to the primary completion date, 31 Dec 2023
  • 7 sites in 1 country
  • 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

  • Participants who have currently a predominant nonplaque form of psoriasis
  • Participants who are pregnant, nursing or planning a pregnancy
  • Participants who are unable or unwilling to undergo multiple venapunctures
  • Participants who are treated according to a different dosing schedule than standard dosing of ixekizumab

Who the study is looking for

  • Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
  • Participants must sign an ICF indicating that he or she understands the purpose of, and procedures required for, the study and is willing to participate in the study

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (7)

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

SiteCityCountrySite status
AZ Sint Jan
Coordinator of this site? Confirm its status
BrugesBelgiumUnknown status
AZ Maria Middelares
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
AZ Sint-Lucas
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
University Hospital of Ghent
Coordinator of this site? Confirm its status
GhentBelgiumUnknown status
UZ Hospital
Coordinator of this site? Confirm its status
LeuvenBelgiumUnknown status
Private Practice Dermatology
Coordinator of this site? Confirm its status
MaldegemBelgiumUnknown status
AZ Delta Rembert
Coordinator of this site? Confirm its status
TorhoutBelgiumUnknown status

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