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A Mono-Center, Prospective Biomarker Study to investigate the differences in the inflammatory gene expression signature, the distribution of immune cells, psoriasis-driving factors and signaling molecules between classic and hard-to-treat psoriasis plaques and the effects of TYK2 blockade with deucravacitinib – MED-PSO

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508948-22-00
Acronym
BMS-IM011-1101
Enrollment
30
Registered
2025-01-17
Start date
Unknown
Completion date
2025-05-05
Last updated
2025-02-10

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

Conditions

moderate to severe plaque psoriasis

Brief summary

The primary endpoint is a change in the expression of the genes IL-17A, IL-17F, IL-22, ß-defensin4A/b and KRT16 compared to baseline in both the classic and hard-to-treat plaques following the treatment with 6 mg Sotyktu® QD for 16 weeks.

Detailed description

• based on the expression of IL-17A, IL-17F, IL-19, IL-22, and IL-36A, the interleukin receptor IL-23R as well as ß-defensine-2 (DEFB4A/B), S100A8/9, KRT16, OASL, MX1, CXCL10, iNOS, CXCR3 and CCL20 as well as IL-31., • CD3 • CD4 • CD11c., • Ki67 • KRT16 • H&E, • STAT-1, • STAT-3 • STAT-4 • STAT-5, • Th1 • Th2 • Th17 • Th17.1 • Treg • DCs • MDSCs, • overall PASI • body site specific local PASI • inverse • scalp • palmoplantar, • Overall • pruritus, pain NRS

Interventions

DRUGSOTYKTU 6 mg film-coated tablets

Sponsors

Charite Universitaetsmedizin Berlin KöR
Lead SponsorOTHER

Eligibility

Sex/Gender
All
Age
18 Years to No maximum

Design outcomes

Primary

MeasureTime frame
The primary endpoint is a change in the expression of the genes IL-17A, IL-17F, IL-22, ß-defensin4A/b and KRT16 compared to baseline in both the classic and hard-to-treat plaques following the treatment with 6 mg Sotyktu® QD for 16 weeks.—

Secondary

MeasureTime frame
• based on the expression of IL-17A, IL-17F, IL-19, IL-22, and IL-36A, the interleukin receptor IL-23R as well as ß-defensine-2 (DEFB4A/B), S100A8/9, KRT16, OASL, MX1, CXCL10, iNOS, CXCR3 and CCL20 as well as IL-31., • CD3 • CD4 • CD11c., • Ki67 • KRT16 • H&E, • STAT-1, • STAT-3 • STAT-4 • STAT-5, • Th1 • Th2 • Th17 • Th17.1 • Treg • DCs • MDSCs, • overall PASI • body site specific local PASI • inverse • scalp • palmoplantar, • Overall • pruritus, pain NRS—

Countries

Germany

Outcome results

None listed

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