Clinical trial NCT04083612: Therapeutic Drug Monitoring of Ixekizumab in Psoriasis Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Keywords: Psoriasis
Therapeutic drug monitoring
Ixekizumab
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University Ghent
First posted: 2019-09-10
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: A prospective, open label, non-randomized study
Primary purpose: TREATMENT

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.

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.

Eligibility 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

Primary outcomes:
measure: Predictive value of early serum trough concentrations of ixekizumab
timeFrame: Week 0 until week 24 of treatment
measure: Predictive value of early anti-drug antibodies of ixekizumab
timeFrame: Week 0 until week 24 of treatment
measure: The development of a therapeutic window of ixekizumab in psoriasis
timeFrame: Week 0 until week 52 of treatment
Secondary outcomes:
measure: DLQI
timeFrame: Week 0 until week 52 of treatment
measure: EQ5D5L
timeFrame: Week 0 until week 52 of treatment
measure: EQ VAS
timeFrame: Week 0 until week 52 of treatment
Other outcomes:
Locations:
city: Ghent
country: Belgium
facility: AZ Maria Middelares
state: Oost-Vlaanderen
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
state: Oost-Vlaanderen
city: Ghent
country: Belgium
facility: University Hospital of Ghent
state: Oost-Vlaanderen
city: Maldegem
country: Belgium
facility: Private Practice Dermatology
state: Oost-Vlaanderen
city: Leuven
country: Belgium
facility: UZ Hospital
state: Vlaams-Brabant
city: Bruges
country: Belgium
facility: AZ Sint-Jan
state: West-Vlaanderen
city: Torhout
country: Belgium
facility: AZ Delta Rembert
state: West-Vlaanderen
Study officials:
affiliation: University Ghent
name: Jo Lambert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: