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Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients (BIOLOPTIM-GUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT04080648
Recruitment Status : Recruiting
First Posted : September 6, 2019
Last Update Posted : June 17, 2020
KU Leuven
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Biologic such as guselkumab 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 guselkumab and determine the therapeutic window of guselkumab 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 guselkumab (i.e. one loading dose (100 mg) at week 0 and week 4 and followed by subcutaenously injections every 8 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards guselkumab. 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
Allocation: N/A
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 Preditive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Guselkumab and the Development of the Concentration-response Curve of Guselkumab for Psoriasis Patients.
Actual Study Start Date : June 27, 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: Guselkumab

Arm Intervention/treatment
Standard of case - guselkumab
Patients will continue to receive guselkumab according to the standard dosing schedule; subcutaneous injection of 100 mg at weeks 0 and 4 and then every 8 weeks
Procedure: Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of guselkumab.

Other: Patient questionnaires
The study participant will complete the dermatology quality of life index (DLQI) and EQ-5D-5L questionnaire at each study visit

Primary Outcome Measures :
  1. Predictive value of early serum trough concentrations of guselkumab [ 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 guselkumab measurements taken from week 0, 1, 2, 3, and/or 4.

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

  3. Development of the therapeutic window of guselkumab in psoriasis [ Time Frame: Week 0 until week 52 of treatment ]
    Defining a therapeutic window for guselkumab 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 (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 [ 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 for the five dimensions can be combined into a 5-digit number that describes the patient's health state.

  3. 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.

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
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 guselkumab

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 identifier (NCT number): NCT04080648

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Contact: Jo Lambert, prof 09 332 22 87 ext +32
Contact: Lynda Grine, dr 09 332 22 87 ext +32

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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   
Contact: Lynda Grine, Dr    09 332 22 87 ext +32   
Private practice Dermatology Not yet recruiting
Maldegem, East-Flanders, Belgium, 9990
Contact: Sven Lanssens, Dr         
University Hospital 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 Hospital, Ghent
KU Leuven
University Ghent
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Principal Investigator: Jo Lambert, Prof. University Ghent
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Responsible Party: University Hospital, Ghent Identifier: NCT04080648    
Other Study ID Numbers: BIOLOPTIM-GUS
First Posted: September 6, 2019    Key Record Dates
Last Update Posted: June 17, 2020
Last Verified: December 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 University Hospital, Ghent:
Therapeutic drug monitoring
Additional relevant MeSH terms:
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Skin Diseases, Papulosquamous
Skin Diseases