Tilrdakizumab Almirall

NCT07244744 | Active Not Recruiting

• 1 other identifier: Tilrdakizumab Almirall
• Study Type: observational
• Target: 3
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Psoriasis

Outcome Measures

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

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

Interventions

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.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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.

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital Schleswig-Holstein: lead

Study Sites (1)

CCIM, Institut für Entzündungsmedizin UKSH Lübeck

Lübeck, <Keine Auswahl>, 23562, Germany

Location

MeSH Terms

Conditions

Psoriasis

Interventions

tildrakizumab

Condition Hierarchy (Ancestors)

Skin Diseases, Papulosquamous; Skin Diseases; Skin and Connective Tissue Diseases

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 17, 2025
• First Posted: November 24, 2025
• Study Start: June 27, 2023
• Primary Completion: December 31, 2024
• Study Completion: April 30, 2026
• Last Updated: November 24, 2025

Record last verified: 2025-11

Locations

DE (1)