Back to resultsTherapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO) (BIOLOPTIM-BRO)
Primary Purpose
Psoriasis Vulgaris
Status
Recruiting
Phase
Not Applicable
Locations
Belgium
Study Type
Interventional
Intervention
Venapuncture
Patient questionnaires
Sponsored by
About this trial
This is an interventional treatment trial for Psoriasis Vulgaris focused on measuring Psoriasis, Therapeutic drug monitoring, Brodalumab
Eligibility 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 brodalumab
Sites / Locations
- AZ Maria Middelares
- AZ Sint-Lucas
- University Hospital of GhentRecruiting
- Private Practice Dermatology
- University Hospital
- AZ Sint-Jan
- AZ Delta Rembert
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Standard of care - brodalumab
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
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.
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.
Secondary Outcome Measures
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.
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.
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.
Full Information
NCT ID
NCT04080635
First Posted
July 19, 2019
Last Updated
January 16, 2023
Sponsor
University Hospital, Ghent
Collaborators
KU Leuven, University Ghent
1. Study Identification
Unique Protocol Identification Number
NCT04080635
Brief Title
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
Acronym
BIOLOPTIM-BRO
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.
Study Type
Interventional
2. Study Status
Record Verification Date
January 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 14, 2018 (Actual)
Primary Completion Date
December 31, 2023 (Anticipated)
Study Completion Date
December 31, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Ghent
Collaborators
KU Leuven, University Ghent
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
Detailed Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
Keywords
Psoriasis, Therapeutic drug monitoring, Brodalumab
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Model Description
A prospective, open label, non-randomized study
Masking
None (Open Label)
Allocation
N/A
Enrollment
100 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Standard of care - brodalumab
Arm Type
Experimental
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Venapuncture
Intervention Description
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab
Intervention Type
Other
Intervention Name(s)
Patient questionnaires
Intervention Description
The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L
Primary Outcome Measure Information:
Title
Predictive value of early serum trough concentrations of brodalumab
Description
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 treatment
Title
Predictive value of early anti-drug antibodies of brodalumab
Description
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 treatment
Title
The development of a therapeutic window of brodalumab in psoriasis
Description
Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.
Time Frame
Week 0 until week 52 of treatment
Secondary Outcome Measure Information:
Title
DLQI
Description
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 treatment
Title
EQ5D5L
Description
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 treatment
Title
EQ VAS
Description
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 treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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 brodalumab
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Jo Lambert, Prof.
Phone
09 332 22 87
Ext
+32
Email
jo.lambert@uzgent.be
First Name & Middle Initial & Last Name or Official Title & Degree
Lynda Grine, Dr.
Phone
09 332 22 87
Ext
+32
Email
lynda.grine@uzgent.be
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, Prof.
Organizational Affiliation
University Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
AZ Maria Middelares
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Linda Temmerman, Dr.
Facility Name
AZ Sint-Lucas
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurence Dierkxsens, Dr.
Facility Name
University Hospital of Ghent
City
Ghent
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9000
Country
Belgium
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jo Lambert, Prof.
Phone
09 332 22 97
Ext
+32
Email
jo.lambert@uzgent.be
First Name & Middle Initial & Last Name & Degree
Lynd Grine, Dr.
Phone
09 332 22 87
Ext
+32
Email
lynda.grine@uzgent.be
Facility Name
Private Practice Dermatology
City
Maldegem
State/Province
Oost-Vlaanderen
ZIP/Postal Code
9990
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sven Lanssens, Dr.
Facility Name
University Hospital
City
Leuven
State/Province
Vlaams-Brabant
ZIP/Postal Code
3000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Tom Hillary, Dr.
Facility Name
AZ Sint-Jan
City
Bruges
State/Province
West-Vlaanderen
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Marleen Goeteyn, Dr.
Facility Name
AZ Delta Rembert
City
Torhout
State/Province
West-Vlaanderen
ZIP/Postal Code
8820
Country
Belgium
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Annelies Stockman, Dr.
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)
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