Clinical trial NCT04080648: Therapeutic Drug Monitoring of Guselkumab in Psoriasis Patients
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.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Psoriasis Vulgaris
Keywords: Therapeutic drug monitoring
Psoriasis
Guselkumab
Lead sponsor: University Hospital, Ghent
Sponsor class: OTHER
Collaborators: name: KU Leuven
name: University Ghent
First posted: 2019-09-06
Enrollment: 79
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: 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.

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.

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 guselkumab

Primary outcomes:
measure: Predictive value of early serum trough concentrations of guselkumab
timeFrame: Week 0 until week 24 of treatment
measure: Predictive value of early anti-drug antibodies of guselkumab
timeFrame: Week 0 until week 24 of treatment
measure: Development of the therapeutic window of guselkumab in psoriasis
timeFrame: Week 0 until week 52 of treatment
Secondary outcomes:
measure: DLQI
timeFrame: Week 0 until week 52 of treatment
measure: EQ-5D-5L
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: East-Flanders
city: Ghent
country: Belgium
facility: AZ Sint-Lucas
state: East-Flanders
city: Ghent
country: Belgium
facility: University Hospital Ghent
state: East-Flanders
city: Maldegem
country: Belgium
facility: Private practice Dermatology
state: East-Flanders
city: Leuven
country: Belgium
facility: University Hospital
state: Vlaams-Brabant
city: Brugge
country: Belgium
facility: AZ Sint-Jan
state: West-Flanders
city: Torhout
country: Belgium
facility: AZ Delta Rembert
state: West-Flanders
Study officials:
affiliation: University Ghent
name: Jo Lambert, Prof.
role: PRINCIPAL_INVESTIGATOR
References: