Monitoring the drug levels of risankizumab in psoriasis patients
Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Risankizumab and the Development of a Response-concentration Curve for Risankizumab in Patients With Psoriasis
This study is testing how well risankizumab works for people with moderate to severe psoriasis by checking their blood levels of the drug to see if it can improve their treatment and quality of life.
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 | risankizumab |
| Locations | 7 sites (Ghent, East-Flanders and 6 other locations) |
| Trial ID | NCT05685940 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of risankizumab, a biologic treatment for moderate to severe psoriasis, by monitoring serum trough levels to optimize dosing. Patients will receive standard doses of risankizumab while their blood will be tested to measure drug levels and the presence of anti-drug antibodies. Additionally, the study will assess the severity of psoriasis using established scoring systems and evaluate the impact on patients' quality of life through questionnaires. The goal is to determine the therapeutic window for risankizumab to improve treatment outcomes.
Who should consider this trial
Good fit: Ideal candidates are individuals diagnosed with chronic plaque-type psoriasis who are willing to participate in the study and undergo blood tests.
Not a fit: Patients with nonplaque forms of psoriasis, those who are pregnant or nursing, or those unable to undergo blood draws may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment plans for psoriasis patients, reducing the risk of over- or undertreatment.
How similar studies have performed: Other studies have shown promise in therapeutic drug monitoring for biologics, suggesting that this approach may enhance treatment efficacy.
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 risankizumab
Where this trial is running
Ghent, East-Flanders and 6 other locations
- AZ Maria Middelares — Ghent, East-Flanders, Belgium (Not_yet_recruiting)
- AZ Sint-Lucas — Ghent, East-Flanders, Belgium (Not_yet_recruiting)
- University Hospital Ghent — Ghent, East-Flanders, Belgium (Recruiting)
- Private practice Dermatology — Maldegem, East-Flanders, Belgium (Not_yet_recruiting)
- University Hospital Leuven — Leuven, Vlaams-Brabant, Belgium (Not_yet_recruiting)
- AZ Sint-Jan — Brugge, West-Flanders, Belgium (Not_yet_recruiting)
- AZ Delta Rembert — Torhout, West-Flanders, Belgium (Not_yet_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.