Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
ConditionPsoriasis Vulgaris
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Ghent
About this trial
Biologics, such as brodalumab, are currently the most effective treatment option for patients with moderate-to-severe psoriasis. But they are costly for health care systems and prescribed according to a 'one dose fits all' dosing regimen, leading to potential over- and undertreatment. Within this study we aim to investigate the predictive value of early serum trough levels of brodalumab and determine the therapeutic window of brodalumab in psoriasis patients.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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 brodalumab
Trial design
Design model
Single group
Treatments tested in this trial
Venapuncture
Procedure/SurgeryBlood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab
Patient questionnaires
Other interventionThe study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L
Treatment groups
100 Participants
are divided into 1 treatment groupGroup A: Standard of care - brodalumabExperimental treatment 2 interventions
Trial outcomes
Primary outcomes
1
Predictive value of early serum trough concentrations of brodalumab
Prediction of the clinical response (PASI) at week 12 and/or week 25 based on serum trough concentrations measurements taken from week 0, 1, 2, 3 and/or 4.
Time frame
Week 0 until week 24 of treatment2
Predictive value of early anti-drug antibodies of brodalumab
Prediction of the clinical response (PASI) at week 12 and/or week 24 based on anti-drug antibodies measurements taken from week 0, 1, 2, 3 and/or 4.
Time frame
Week 0 until week 24 of treatment3
The development of a therapeutic window of brodalumab in psoriasis
Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.
Time frame
Week 0 until week 52 of treatmentSecondary outcomes
1
DLQI
The DLQI (Dermatology Life Quality Index) (range 0-30) is a dermatology specific quality of life (QoL) instrument designed to assess the impact of the disease on participant's QoL. It is a ten item questionnaire that, in addition to evaluated overall QoL, can be used to assess six different aspects that may affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leasure, 4) work or school performances, 5) personal relationships, and 6) treatment. The scoring of each question is as follows: Very much - scored 3; A lot - scored 2; A little - scored 1; Not at all - scored 0; Not relevant - scored 0; Question 7, 'prevented work or studying' - scored 3. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more quality of life is impaired.
Time frame
Week 0 until week 52 of treatment2
EQ5D5L
EQ5DL comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. The patient is asked to indicate his/her health state by ticking the box next to the most appropriate statement in each of the five dimensions. This decision results in a 1-digit number that expresses the level selected for that dimension. The digits for the five dimensions can be combined into a 5-digit number that describes the patient's health state.
Time frame
Week 0 until week 52 of treatment3
EQ VAS
The EQ VAS (Visual Analogue Scale) (range 0-10) records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.
Time frame
Week 0 until week 52 of treatmentSponsors and contacts
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Source ClinicalTrials.gov