RecruitingRecruiting
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
NCT04080635 · University Hospital, Ghent
In plain English
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Official title
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.
About this study
Patients will be included after siging informed consent. After inclusion, patients will continue on standard dosing schedule of brodalumab (i.e. one loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards brodalumab. In addition, the Psoriasis Severity and Area Index (PASI) and the Investigator's Global Assessment (IGA) score will be evaluated by a physician. Patients complete the Dermatology Life Quality Index (DLQI) and European quality of life EQ-5D instrument at each visit.
Eligibility 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
Study design
Enrollment target: 100 participants
Allocation: na
Masking: none
Age groups: adult, older_adult
Timeline
Starts: 2018-12-14
Estimated completion: 2024-12-31
Last updated: 2024-09-19
Interventions
Procedure: VenapunctureOther: Patient questionnaires
Primary outcomes
- • Predictive value of early serum trough concentrations of brodalumab (Week 0 until week 24 of treatment)
- • Predictive value of early anti-drug antibodies of brodalumab (Week 0 until week 24 of treatment)
- • The development of a therapeutic window of brodalumab in psoriasis (Week 0 until week 52 of treatment)
Sponsor
University Hospital, Ghent · other
With: KU Leuven, University Ghent
Contacts & investigators
ContactJo Lambert, Prof. · contact · jo.lambert@uzgent.be · 09 332 22 87
ContactLynda Grine, Dr. · contact · lynda.grine@uzgent.be · 09 332 22 87
InvestigatorJo Lambert, Prof. · principal_investigator, University Ghent
All locations (7)
AZ Maria MiddelaresNot Yet Recruiting
Ghent, Oost-Vlaanderen, Belgium
AZ Sint-LucasNot Yet Recruiting
Ghent, Oost-Vlaanderen, Belgium
University Hospital of GhentRecruiting
Ghent, Oost-Vlaanderen, Belgium
Private Practice DermatologyNot Yet Recruiting
Maldegem, Oost-Vlaanderen, Belgium
University HospitalNot Yet Recruiting
Leuven, Vlaams-Brabant, Belgium
AZ Sint-JanNot Yet Recruiting
Bruges, West-Vlaanderen, Belgium
AZ Delta RembertNot Yet Recruiting
Torhout, West-Vlaanderen, Belgium