An Explorative Psoriasis Biomarker Study

Sponsor
Centre for Human Drug Research, Netherlands
Study ID
NCT04394936
Status
Terminated

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Accepted

Interventions

  • Guselkumab — DRUG
    100 mg guselkumab administered subcutaneously
  • Placebos — DRUG
    Sodiumchloride 0,9% solution for injection

Study Details

Plaque psoriasis may be an ideal model disease to explore potential therapeutic effects of immunosuppressive agents, given the easy accessibility of inflammatory lesions. In this study, the applicability of a systems dermatology approach is investigated in order to better assess the efficacy of psoriasis treatments at an early clinical stage. Up to this point, the clinical manifestation and regression of psoriasis is not yet sufficiently characterized with a multimodal state-of-the-art evaluation tool. The in-house developed 'DermaToolbox' enables the determination and subsequent integration of different diseaserelated biomarkers, including clinical, biophysical, molecular, cellular, and imaging markers as well as patient reported outcomes

Key Dates

Start date
Sep 1, 2020
Status verified
Jun 2025
Primary completion
Feb 22, 2023
Completion
Mar 27, 2023

Study Design

Enrollment
37 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Guselkumab
    Guselkumab 100 mg/ml in prefilled syringe, subcutaneous injection, administered on day 0, 28 and 84.
  • Placebo Comparator: Placebo
    Sodiumchloride 0,9% solution for injection, subcutaneous injection, administered on day 0, 28 and 84.
  • No Intervention: Healthy volunteers
    Healthy volunteer cohort (observational)

Primary Outcome Measure

Psoriasis Area and Severity Index (PASI) Assessment [ Time Frame: from day -14 to day 168 ]

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