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Therapeutic Drug Monitoring of Seckinumab in Psoriasis Patients. (BIOLOPTIM-SEC)

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ClinicalTrials.gov Identifier: NCT04080661
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : September 6, 2019
Sponsor:
Collaborator:
KU Leuven
Information provided by (Responsible Party):
VakgroepHoofdEnHuid, University Ghent

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Intervention Model: Single Group Assignment
Intervention Model Description: A 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 : March 22, 2018
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Psoriasis
Drug Information available for: Secukinumab

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.




Primary Outcome Measures :
  1. Predictive value of early serum trough concentrations of secukinumab [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: 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 [ Time Frame: Week 0 until week 52 of treatment ]
    The DLQI is a dermatology-specific quality of life (QoL) instrument designed to assess the impact of the disease on a participant's QoL. It is a 10-item questionnaire that, in addition to evaluating overall Qol, can be used to assess six different aspects that mey affect QoL: 1) symptoms and feelings, 2) daily activities, 3) leisure, 4) work or school performance, 5) personal relationships, and 6) treatment.

  2. EQ-5D-5L [ Time Frame: 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 [ Time Frame: Week 0 until week 52 of treatment ]
    The EQ VAS recores the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can image' and 'The worst health you can image'. The VAS can be used as a quantitative measure of health outcome that reflect the patient's own judgement.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04080661


Contacts
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Contact: Jo Lambert, Prof. 09 332 22 87 ext +32 jo.lambert@uzgent.be
Contact: Lynd Grine, Dr. 09 332 22 87 ext +32 lynda.grine@uzgent.be

Locations
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Belgium
AZ Maria Middelares Not yet recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Linda Temmerman, Dr         
AZ Sint-Lucas Not yet recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Laurence Dierckxssens, Dr         
University Hospital Ghent Recruiting
Ghent, East-Flanders, Belgium, 9000
Contact: Jo Lambert, Prof    09 332 22 87 ext +32    jo.lambert@uzgent.be   
Contact: Lynda Grine, Dr    09 332 22 87 ext +32    lynda.grine@uzgent.be   
Private practice Dermatology Not yet recruiting
Maldegem, East-Flanders, Belgium, 9990
Contact: Sven Lanssens, Dr         
University Hospital Leuven Not yet recruiting
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Tom Hillary, Dr         
AZ Sint-Jan Not yet recruiting
Brugge, West-Flanders, Belgium, 8000
Contact: Marleen Goeteyn, Dr         
AZ Delta Rembert Not yet recruiting
Torhout, West-Flanders, Belgium, 8820
Contact: Annelies Stockman, Dr         
Sponsors and Collaborators
University Ghent
KU Leuven
Investigators
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Principal Investigator: Jo Lambert, Prof. University Ghent

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Responsible Party: VakgroepHoofdEnHuid, Prof dr Jo Lambert, University Ghent
ClinicalTrials.gov Identifier: NCT04080661     History of Changes
Other Study ID Numbers: BIOLOPTIM-SEC
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: September 6, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by VakgroepHoofdEnHuid, University Ghent:
Therapeutic drug monitoring
Psoriasis
Secukinumab
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases
Antibodies, Monoclonal
Immunologic Factors
Physiological Effects of Drugs