Monitoring drug levels of brodalumab in psoriasis patients
Evaluation of the Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Brodalumab and the Development of Concentration-response Curve of Brodalumab of Psoriasis Patients.
This study tests how well the psoriasis drug brodalumab works by checking its levels in the blood to see if adjusting the dose can help patients feel better.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 100 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Ghent Academic / other |
| Drugs / interventions | brodalumab |
| Locations | 7 sites (Ghent, Oost-Vlaanderen and 6 other locations) |
| Trial ID | NCT04080635 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of brodalumab, a biologic treatment for moderate-to-severe psoriasis, by monitoring serum trough levels to optimize dosing. Patients will receive standard doses of brodalumab while their blood will be tested to measure drug levels and the presence of anti-drug antibodies. Additionally, the severity of psoriasis will be assessed using established clinical scoring systems, and patients will complete quality of life questionnaires at each visit. The goal is to determine the therapeutic window for brodalumab 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 or those unable to comply with the study's requirements may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more personalized and effective treatment regimens for psoriasis patients, reducing costs and improving health outcomes.
How similar studies have performed: Other studies have shown promise in optimizing biologic treatments through therapeutic drug monitoring, suggesting this approach could be beneficial.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis 2. 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: 1. Participants who have currently a predominant nonplaque form of psoriasis 2. Participants who are pregnant, nursing or planning a pregnancy 3. Participants who are unable or unwilling to undergo multiple venapunctures 4. Participants who are treated according to a different dosing schedule than standard dosing of brodalumab
Where this trial is running
Ghent, Oost-Vlaanderen and 6 other locations
- AZ Maria Middelares — Ghent, Oost-Vlaanderen, Belgium (Not_yet_recruiting)
- AZ Sint-Lucas — Ghent, Oost-Vlaanderen, Belgium (Not_yet_recruiting)
- University Hospital of Ghent — Ghent, Oost-Vlaanderen, Belgium (Recruiting)
- Private Practice Dermatology — Maldegem, Oost-Vlaanderen, Belgium (Not_yet_recruiting)
- University Hospital — Leuven, Vlaams-Brabant, Belgium (Not_yet_recruiting)
- AZ Sint-Jan — Bruges, West-Vlaanderen, Belgium (Not_yet_recruiting)
- AZ Delta Rembert — Torhout, West-Vlaanderen, 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.