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Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients (BIOLOPTIM-IXE)

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.
 
ClinicalTrials.gov Identifier: NCT04083612
Recruitment Status : Not yet recruiting
First Posted : September 10, 2019
Last Update Posted : June 29, 2020
Sponsor:
Collaborators:
KU Leuven
University Ghent
Information provided by (Responsible Party):
University Hospital, Ghent

Brief Summary:
Biologics, such as ixekizumab, 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 the investigators aim to investigate the predictive value of early serum trough levels of ixekizumab and determine the therapeutic window of ixekizumab 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 siging informed consent. After inclusion, patients will continue on standard dosing schedule of ixekizumab (i.e. one loading dose of 2 subcutaneous injections (160 mg) at week 0, followed by one subcutaneous injection (80 mg) every 2 weeks for 12 weeks, and then one subcutaneous injections (80 mg) every 4 weeks). During each study visit, blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards ixekizumab. 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.

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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 Predictive Value of Early Serum Trough Concentrations and Anti-drug Antibodies of Ixekizumab and the Development of Concentration-response Curve of Ixekizumab for Psoriasis Patients
Estimated Study Start Date : July 1, 2020
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: Ixekizumab

Arm Intervention/treatment
Standard of care - ixekizumab
Patient will continue to receive ixekizumab according to standard of care dosing regimen, i.e. loading dose first (160 mg) at week 0; 80 mg every 2 weeks until week 12, then 80 mg every 4 weeks
Procedure: Venapuncture
Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of ixekizumab

Other: Patient questionnaires
The study participant will complete the Dermatology Quality of Life Index (DLQI) and EQ5D5L questionnaires at each study visit.




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

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

  3. The development of a therapeutic window of ixekizumab in psoriasis [ Time Frame: Week 0 until week 52 of treatment ]
    Defining a therapeutic window for ixekizumab based on serum trough levels 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. EQ5D5L [ Time Frame: Week 0 until week 52 of treatment ]

    The 5-level EQ-5D version (EQ-5D-5L) was introduced by the EuroQol Group in 2009 to improve the instrument's sensitivity and to reduce ceiling effects.

    The descriptive system comprises five dimensions: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each dimension has 5 levels: no problems (level 1), slight problems (level 2), moderate problems (level 3), severe problems (level 4) and extreme problems (level 5). 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, which is the outcome result. There is no minimum or maximum score since the the 5 digit-number is a non-numeric variable.


  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. Minimum score is 0%, max. score is 100%. Lower values mean 'worse health the patient can imagine', higher values mean 'better health the patient can imagine'.



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
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 ixekizumab

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): NCT04083612


Contacts
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Contact: Jo Lambert, Prof. 09 322 22 87 ext +32 jo.lambert@uzgent.be
Contact: Lynd Grine, dr 09 322 22 87 ext +32 lynda.grine@uzgent.be

Locations
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Belgium
AZ Maria Middelares
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Linda Temmerman, Dr.         
AZ Sint-Lucas
Ghent, Oost-Vlaanderen, Belgium, 9000
Contact: Laurence Dierkxsens, Dr.         
University Hospital of Ghent
Ghent, Oost-Vlaanderen, 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
Maldegem, Oost-Vlaanderen, Belgium, 9990
Contact: Lanssens Sven, Dr.         
UZ Hospital
Leuven, Vlaams-Brabant, Belgium, 3000
Contact: Tom Hillary, Dr.         
AZ Sint-Jan
Bruges, West-Vlaanderen, Belgium, 8000
Contact: Marleen Goeteyn, Dr.         
AZ Delta Rembert
Torhout, West-Vlaanderen, Belgium, 8820
Contact: Annelies Stockman, Dr.         
Sponsors and Collaborators
University Hospital, Ghent
KU Leuven
University Ghent
Investigators
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Principal Investigator: Jo Lambert, Prof. University Ghent
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Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT04083612    
Other Study ID Numbers: BIOLOPTIM-IXE
First Posted: September 10, 2019    Key Record Dates
Last Update Posted: June 29, 2020
Last Verified: June 2020
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:
Psoriasis
Therapeutic drug monitoring
Ixekizumab
Additional relevant MeSH terms:
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Psoriasis
Skin Diseases, Papulosquamous
Skin Diseases