Therapeutic Drug Monitoring of Secukinumab in Psoriasis Patients. (BIOLOPTIM-SEC)

  • End date
    Dec 31, 2023
  • participants needed
  • sponsor
    University Hospital, Ghent
Updated on 21 February 2022


Biologics such as secukinumab 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 secukinumab and determine the therapeutic window of secukinumab in psoriasis patients.


Patients will be included after signing informed consent. After inclusion, patients will continue on standard dosing schedule of secukinumab (i.e. subcutaneous injections once a week for 5 weeks (300 mg) followed by subcutaneous injections every 4 weeks). During each study visit blood will be taken in order to quantify Ctroughs and/or anti-drug antibodies towards secukinumab. 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.

Condition Psoriasis Vulgaris
Treatment Patient questionnaires, Venapuncture
Clinical Study IdentifierNCT04080661
SponsorUniversity Hospital, Ghent
Last Modified on21 February 2022


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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 secukinumab
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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