Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Tildrakizumab and the Development of a Concentration Response Curve of Tildrakizumab for Psoriasis Patients
Status: Recruiting
Location: See all (2) locations...
Intervention Type: Procedure
Study Type: Interventional
Study Phase: Phase 4
SUMMARY
Biologics such as tildrakizumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a 'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study, the investigators aim to investigate the predictive value of early serum trough levels of tildrakizumab and determine the therapeutic window of tildrakizumab in psoriasis patients.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:
• 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
Locations
Other Locations
Belgium
University Hospital Ghent
RECRUITING
Ghent
University Hospital Ghent
RECRUITING
Ghent
Contact Information
Primary
Jo Lambert, Prof.
jo.lambert@uzgent.be
09 332 22 87
Backup
Rani Soenen, Dr
rani.soenen@uzgent.be
09 332 65 41
Time Frame
Start Date: 2022-08-22
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 100
Treatments
Experimental: Standard of care - tildrakizumab
Patients will continue to receive tildrakizumab according to the standard dosing schedule: subcutaneous injections at weeks 0 and 4, then every 12 weeks (100mg)
Related Therapeutic Areas
Sponsors
Leads: University Hospital, Ghent