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Active, Not Recruiting

NCT Number: NCT07244744

Tilrdakizumab Almirall

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.

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Conditions

Psoriasis Skin Diseases Skin Diseases, Papulosquamous Skin and Connective Tissue Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

CCIM, Institut für Entzündungsmedizin UKSH Lübeck

Lübeck, <Keine Auswahl>, 23562, Germany

Who can participate

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Tildrakizumab

Biological

Tildrakizumab, a monoclonal antibody targeting IL-23 p19, reduces inflammation in moderate to severe plaque psoriasis. Administered subcutaneously it improves skin symptoms and is well tolerated.

Primary outcomes

  1. 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

    Time frame: Assessment of changes in Trm/Treg cell ratio at early (2 weeks) and late (16 weeks) time points after initiation of Tildrakizumab treatment.

Sponsors and collaborators

Lead sponsor

University Hospital Schleswig-Holstein

Other

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2024
Study completion
2026
First posted
Nov 24, 2025
Registry last updated
Nov 24, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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