Skip to content

AN INVESTIGATOR-INITIATED, PHASE 4, OPEN-LABEL, SINGLE-ARM, SINGLE-CENTER STUDY INVESTIGATING THE TISSUE-RESIDENT MEMORY T-CELLS AND DISEASE MEMORY IN PSORIASIS SKIN DURING GUSELKUMAB TREATMENT. THE GUSMEM STUDY.

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-503776-25-00
Acronym
GUSMEM01
Enrollment
15
Registered
2023-04-28
Start date
2023-06-19
Completion date
Unknown
Last updated
2024-03-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Psoriasis vulgaris

Brief summary

Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103., Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.

Detailed description

Change in CD11c+ Dendritic cells over the study duration., Change in CD163+ Macrophages over the study duration., Change in Langerin+/CD207+ Langerhans-cells over the study duration., Change in Myeloperoxidase+ Neutrophils over the study duration., Change in CD4+/FOXP3+ single and double positive cells over the study duration., Change in CD103/RORγt single and double positive cells over the study duration., Change in CD3+, CD4+, CD8+, CD49a+, CD69+, and CD103+ multiple, or single positive cells over the study duration., Change in proliferation assessed using Ki67+ staining over the study duration., Change in epidermal thickness over the study duration.

Interventions

Sponsors

Aarhus University Hospital
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
Change in the protein expression using DSP in the microenvironment surrounding TRMs in the epidermis. The following markers in combination will be used to differentiate TRMs: CD3, CD4, CD8, CD103., Change in the number of TRMs in the epidermis and dermis between baseline and EOT using IHC. The following markers in combination will be used to differentiate cells: CD3, CD4, CD8, CD103.

Secondary

MeasureTime frame
Change in CD11c+ Dendritic cells over the study duration., Change in CD163+ Macrophages over the study duration., Change in Langerin+/CD207+ Langerhans-cells over the study duration., Change in Myeloperoxidase+ Neutrophils over the study duration., Change in CD4+/FOXP3+ single and double positive cells over the study duration., Change in CD103/RORγt single and double positive cells over the study duration., Change in CD3+, CD4+, CD8+, CD49a+, CD69+, and CD103+ multiple, or single positive cells over the study duration., Change in proliferation assessed using Ki67+ staining over the study duration., Change in epidermal thickness over the study duration.

Countries

Denmark

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026