Therapeutic Drug Monitoring of Brodalumab in Psoriasis Patients (BIOLOPTIM-BRO)

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04080635
• Collaborator: KU Leuven (Other), University Ghent (Other)
• Enrollment: 100
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 60.6
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.2

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Procedure: Venapuncture; Other: Patient questionnaires	N/A

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.

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: A prospective, open label, non-randomized studyA prospective, open label, non-randomized study
• Masking: None (Open Label)
• Primary Purpose: Treatment
• 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.
• Actual Study Start Date: Dec 14, 2018
• Anticipated Primary Completion Date: Dec 31, 2022
• Anticipated Study Completion Date: Dec 31, 2023

Arms and Interventions

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.	Procedure: Venapuncture; Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of brodalumab; Other: Patient questionnaires; The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L

Outcome Measures

Primary Outcome Measures

1. Predictive value of early serum trough concentrations of brodalumab [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.

2. Predictive value of early anti-drug antibodies of brodalumab [Week 0 until week 24 of treatment]

   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.

3. The development of a therapeutic window of brodalumab in psoriasis [Week 0 until week 52 of treatment]

   Defining a therapeutic window for brodalumab based on serum trough levels corresponding with adequate clinical response.

Secondary Outcome Measures

1. DLQI [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.

2. EQ5D5L [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.

3. EQ VAS [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.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Maria Middelares	Ghent	Oost-Vlaanderen	Belgium	9000
2	AZ Sint-Lucas	Ghent	Oost-Vlaanderen	Belgium	9000
3	University Hospital of Ghent	Ghent	Oost-Vlaanderen	Belgium	9000
4	Private Practice Dermatology	Maldegem	Oost-Vlaanderen	Belgium	9990
5	University Hospital	Leuven	Vlaams-Brabant	Belgium	3000
6	AZ Sint-Jan	Bruges	West-Vlaanderen	Belgium	8000
7	AZ Delta Rembert	Torhout	West-Vlaanderen	Belgium	8820

Sponsors and Collaborators

• University Hospital, Ghent
• KU Leuven
• University Ghent

Investigators

• Principal Investigator: Jo Lambert, Prof., University Ghent

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: University Hospital, Ghent
• ClinicalTrials.gov Identifier: NCT04080635
• Other Study ID Numbers: BIOLOPTIM-BRO
• First Posted: Sep 6, 2019
• Last Update Posted: Jun 17, 2020
• Last Verified: Dec 1, 2019

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by University Hospital, Ghent: Psoriasis; Therapeutic drug monitoring; Brodalumab
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Jun 17, 2020