Tilrdakizumab Almirall

Investigating the Mechanisms of Short- and Long-term Responses to IL-23 Inhibition Using Tildrakizumab in Moderate to Severe Plaque Psoriasis Using High-definition Multiomics

Define the mechanisms underlying the short- and the long-lasting effects of IL-23 targeting in plaque PsO, by characterizing the longitudinal effects of IL-23 inhibition on the ratio of Trm/Treg cells in the skin of moderate to severe plaque PsO patients. HDST (Visium HD) and HDSP (MICS) are used to characterize the early (2 weeks) and late (16 weeks) molecular effects of treatment with tildrakizumab on the skin of three patients with moderate to severe plaque psoriasis. Non-lesional and lesional skin samples taken at the start of treatment with tildrakizumab will be used, as well as healed skin adjacent to the original sampling sites at week 2 and week 16 after the start of treatment with tildrakizumab. The same samples will be examined using Visium HD and the MACSima imaging system.

Study Overview

• Status: Active, not recruiting
• Conditions: Psoriasis
• Intervention / Treatment: Biological: Tildrakizumab

• Study Type: Observational
• Enrollment (Actual): 3

Contacts and Locations

Study Locations

• Germany
  • <Keine Auswahl>
    • Lübeck, <Keine Auswahl>, Germany, 23562
      • CCIM, Institut für Entzündungsmedizin UKSH Lübeck

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

Study Population

The study population consists of adult patients (18 years and older) with moderate to severe plaque psoriasis. These patients have a confirmed diagnosis and are eligible for treatment with Tildrakizumab. These patients are selected from existing biobank samples with informed consent for molecular analysis related to IL-23 inhibition.

Description

Inclusion Criteria:

• Adult patients (18 years or older) with a diagnosis of moderate to severe chronic plaque psoriasis.
• Patients eligible for treatment with an IL-23 inhibitor, specifically Tildrakizumab.

Exclusion Criteria:

• Patients unable to comply with the study requirements.
• Known hypersensitivity to IL-23 inhibitors.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Change in tissue-resident memory T cells (Trm) to regulatory T cells (Treg) ratio in lesional, non-lesional, and resolved skin at weeks 2 and 16 after Tildrakizumab treatment, assessed by high-definition spatial transcriptomics (Visium HD) and high-dimen	Assessment of changes in Trm/Treg cell ratio at early (2 weeks) and late (16 weeks) time points after initiation of Tildrakizumab treatment.

Collaborators and Investigators

• Sponsor: University Hospital Schleswig-Holstein

Study record dates

Study Major Dates

• Study Start (Actual): June 27, 2023
• Primary Completion (Actual): December 31, 2024
• Study Completion (Estimated): April 30, 2026

Study Registration Dates

• First Submitted: November 17, 2025
• First Submitted That Met QC Criteria: November 17, 2025
• First Posted (Actual): November 24, 2025

Study Record Updates

• Last Update Posted (Actual): November 24, 2025
• Last Update Submitted That Met QC Criteria: November 17, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases; Psoriasis; tildrakizumab
• Other Study ID Numbers: Tilrdakizumab Almirall

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED