Tilrdakizumab Almirall

Condition(s) studied

Investigational drug(s) / intervention(s)

Tildrakizumab: 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.

Study 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.

Eligibility

Primary outcome measure(s)

• 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.

Trial sites (1)

More University Hospital Schleswig-Holstein trials in Germany

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