BIOLOPTIM-SEC: Therapeutic Drug Monitoring of Secukinumab in Psoriasis Patients.

• Sponsor: University Hospital, Ghent (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT04080661
• Collaborator: KU Leuven (Other), University Ghent (Other)
• Enrollment: 100
• Locations: 7
• Arm: 1
• Anticipated Duration (Months): 69.3
• Patients Per Site: 14.3
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Biologics such as secukinumab are currently the most effective treatment option for patients with moderate to severe psoriasis. But they are costly for healthcare systems and still described according to a'one dose fits all' dosing regimen, leading to potential over-and undertreatment. In this study we aim to investigate the predictive value of early serum trough levels of secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Procedure: Venapuncture; Other: Patient questionnaires	Phase 4

Detailed Description

Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of secukinumab (i.e. subcutaneous injections once a week for 5 weeks (300 mg) followed by subcutaneous injections every 4 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards secukinumab. In addition, Psoriasis Area and Severity Index (PASI) and 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 Secukinumab and the Development of a Concentration Response Curve of Secukinumab for Psoriasis Patients.
• Actual Study Start Date: Mar 22, 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 - secukinumab Patients will continue to receive secukinumab according to the standard dosing schedule: subcutaneous injections once a week for 5 weeks, then every 4 weeks (300 mg).	Procedure: Venapuncture; Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of secukinumab.; Other: Patient questionnaires; The study participants will complete the Dermatology Quality of Life (DLQI) and EQ-5D-5L questionnaire at each study visit.

Outcome Measures

Primary Outcome Measures

1. Predictive value of early serum trough concentrations of secukinumab [Week 0 until week 24 of treatment]

   Prediction of the clinical response (PASI) at week 12 and/or week 24 based on serum trough concentrations of secukinumab measurements taken from week 0,1,2,3 and/or 4.

2. Predictive value of early anti-drug antibodies of secukinumab [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 (ADA) measurements taken from week 0,1,2,3 and/or 4.

3. Development of the therapeutic window of secukinumab in psoriasis [Week 0 until week 52 of treatment]

   Defining a therapeutic window for secukinumab based on serum trough concentrations 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. EQ-5D-5L [Week 0 until week 52 of treatment]

   The EQ-5D-5L 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 of the five dimensions can be combined into a 5- digit number that describes the patients' 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 secukinumab

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	AZ Maria Middelares	Ghent	East-Flanders	Belgium	9000
2	AZ Sint-Lucas	Ghent	East-Flanders	Belgium	9000
3	University Hospital Ghent	Ghent	East-Flanders	Belgium	9000
4	Private practice Dermatology	Maldegem	East-Flanders	Belgium	9990
5	University Hospital Leuven	Leuven	Vlaams-Brabant	Belgium	3000
6	AZ Sint-Jan	Brugge	West-Flanders	Belgium	8000
7	AZ Delta Rembert	Torhout	West-Flanders	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: NCT04080661
• Other Study ID Numbers: BIOLOPTIM-SEC
• First Posted: Sep 6, 2019
• Last Update Posted: Oct 6, 2020
• Last Verified: Oct 1, 2020

• 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: Therapeutic drug monitoring; Psoriasis; Secukinumab
• Additional relevant MeSH terms: Psoriasis

Study Results

No Results Posted as of Oct 6, 2020