Exploring the Effects of IL-23 Inhibition by Risankizumab on Psoriasis Autoimmunity

Sponsor
Istituto Clinico Humanitas
Study ID
NCT04722640
Phase
PHASE4
Status
Unknown

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

  • SKYRIZI — DRUG
    SKYRIZI

Study Details

Approximately 80 patients affected by moderate to severe psoriasis will be screened for the presence of LL37( and ADAMTSL5 autoreactive T-cells in their blood at Day 0. Patients whose lymphocytes reacted with proliferation to LL37 or ADAMTSL5 will receive SKYRIZI (Risakizumab) at Day 1, week 4, 16, 28, 40. LL37 and ADAMTSL5-specific T-cell responses will be evaluated at Day 0, week 16, week 28 and week 52. Each patient will be followed for 52 weeks.

Key Dates

Start date
Jan 25, 2021
Status verified
Jan 2021
Primary completion
Jan 31, 2022
Completion
Jan 31, 2022

Study Design

Enrollment
240 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: RISAKIZUMAB
    SKYRIZI

Primary Outcome Measure

Proportion of activated autoantigen-specific T-cells [ Time Frame: 12 Months ]

Central Contacts

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