- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04080635
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO) (BIOLOPTIM-BRO)
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.
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Jo Lambert, Prof.
- Phone Number: +32 09 332 22 87
- Email: jo.lambert@uzgent.be
Study Contact Backup
- Name: Lynda Grine, Dr.
- Phone Number: +32 09 332 22 87
- Email: lynda.grine@uzgent.be
Study Locations
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Oost-Vlaanderen
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Not yet recruiting
- AZ Maria Middelares
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Contact:
- Linda Temmerman, Dr.
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Not yet recruiting
- AZ Sint-Lucas
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Contact:
- Laurence Dierkxsens, Dr.
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Ghent, Oost-Vlaanderen, Belgium, 9000
- Recruiting
- University Hospital of Ghent
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Contact:
- Lynd Grine, Dr.
- Phone Number: +32 09 332 22 87
- Email: lynda.grine@uzgent.be
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Contact:
- Jo Lambert, Prof.
- Phone Number: +32 09 332 22 97
- Email: jo.lambert@uzgent.be
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Maldegem, Oost-Vlaanderen, Belgium, 9990
- Not yet recruiting
- Private practice Dermatology
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Contact:
- Sven Lanssens, Dr.
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Vlaams-Brabant
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Leuven, Vlaams-Brabant, Belgium, 3000
- Not yet recruiting
- University Hospital
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Contact:
- Tom Hillary, Dr.
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West-Vlaanderen
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Bruges, West-Vlaanderen, Belgium, 8000
- Not yet recruiting
- AZ Sint-Jan
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Contact:
- Marleen Goeteyn, Dr.
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Torhout, West-Vlaanderen, Belgium, 8820
- Not yet recruiting
- AZ Delta Rembert
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Contact:
- Annelies Stockman, Dr.
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 brodalumab
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Standard of care - brodalumab
Patients will continue to receive brodalumab according to standard care dosing regimen, i.e. loading dose first (210mg), once a week for 2 weeks (210mg), then a regular dose regimen (210mg) every 2 weeks.
|
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab
The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Predictive value of early serum trough concentrations of brodalumab
Time Frame: Week 0 until week 24 of treatment
|
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.
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Week 0 until week 24 of treatment
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Predictive value of early anti-drug antibodies of brodalumab
Time Frame: Week 0 until week 24 of treatment
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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.
|
Week 0 until week 24 of treatment
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The development of a therapeutic window of brodalumab in psoriasis
Time Frame: Week 0 until week 52 of treatment
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Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.
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Week 0 until week 52 of treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
DLQI
Time Frame: Week 0 until week 52 of treatment
|
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. |
Week 0 until week 52 of treatment
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EQ VAS
Time Frame: Week 0 until week 52 of treatment
|
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.
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Week 0 until week 52 of treatment
|
EQ5D5L
Time Frame: Week 0 until week 52 of treatment
|
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.
|
Week 0 until week 52 of treatment
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jo Lambert, Prof., University Ghent
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- BIOLOPTIM-BRO
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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