Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | 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. |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CCIM, Institut für Entzündungsmedizin UKSH Lübeck | Lübeck | <Keine Auswahl> | 23562 | Germany |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Oct 9, 2025 | Oct 20, 2025 | Prot_000.pdf |
Not provided
| ID | Term |
|---|---|
| D011565 | Psoriasis |
| ID | Term |
|---|---|
| D017444 | Skin Diseases, Papulosquamous |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C000598434 | tildrakizumab |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided