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Completed

NCT Number: NCT04083612

Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients

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.

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Key information

Conditions

Psoriasis Vulgaris Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

AZ Maria Middelares, Ghent, Oost-Vlaanderen, Belgium

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Participants must have a clinical or histological diagnosis of chronic plaque-type psoriasis
  • 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

  • Participants who have currently a predominant nonplaque form of psoriasis
  • Participants who are pregnant, nursing or planning a pregnancy
  • Participants who are unable or unwilling to undergo multiple venapunctures
  • Participants who are treated according to a different dosing schedule than standard dosing of ixekizumab

Treatment and study plan

Venapuncture

Procedure

Blood samples will be collected to determine the serum trough levels and anti-drug antibodies of ixekizumab

Patient questionnaires

Other

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

Primary outcomes

  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 outcomes

  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'.

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • KU Leuven
  • University Ghent

Registry information

Official study 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

Acronym: BIOLOPTIM-IXE

Important dates

Study start
2020
Primary completion
2023
Study completion
2023
First posted
Sep 10, 2019
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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