Monitoring Tildrakizumab Levels in Psoriasis Patients
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
This study tests how well a psoriasis medication called tildrakizumab works for patients by checking its levels in their blood and seeing how it affects their daily lives.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | tildrakizumab |
| Locations | 2 sites (Ghent, East-Flanders and 1 other locations) |
| Trial ID | NCT05683015 on ClinicalTrials.gov |
What this trial studies
This study investigates the therapeutic drug monitoring of tildrakizumab, a biologic treatment for moderate to severe psoriasis. Patients will receive standard doses of tildrakizumab while their serum trough levels and anti-drug antibodies will be measured at each visit. The study aims to determine the optimal therapeutic window for this medication, potentially leading to more personalized treatment approaches. Additionally, patients will complete quality of life assessments to evaluate the impact of treatment on their daily lives.
Who should consider this trial
Good fit: Ideal candidates are individuals with chronic plaque-type psoriasis who are willing to participate in the study and undergo multiple blood draws.
Not a fit: Patients with nonplaque forms of psoriasis, those who are pregnant or nursing, or those on a different dosing schedule will not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more effective and personalized dosing of tildrakizumab, improving treatment outcomes for psoriasis patients.
How similar studies have performed: Other studies have shown promise in therapeutic drug monitoring for biologics, suggesting that this approach could be beneficial for optimizing treatment.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 tildrakizumab
Where this trial is running
Ghent, East-Flanders and 1 other locations
- University Hospital Ghent — Ghent, East-Flanders, Belgium (Recruiting)
- University Hospital Ghent — Ghent, Belgium (Recruiting)
Study contacts
- Principal investigator: Jo Lambert, Prof — University Ghent
- Study coordinator: Jo Lambert, Prof.
- Email: jo.lambert@uzgent.be
- Phone: 09 332 22 87
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.