The effect of anifrolumab on cutaneous lupus erythematosus characterized by the change of the inflammatory infiltrate analyzed by immunohistochemistry, spatial transcriptomics and single-cell RNA- and TCR-sequencing as well as on the clinical outcome - an open label, single arm phase IV pilot study

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2025-523133-26-00

Enrollment

Registered

2026-02-07

Start date

Unknown

Completion date

Unknown

Last updated

2026-02-07

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

Conditions

cutaneous lupus erythematosus

Brief summary

changes in inflammatory cell composition and gene expression profiles in skin and blood samples.

Detailed description

the impact of anifriolumab therapy on the clinical course of patients with cutaneous lupus erythematosus.

Interventions

DRUGSaphnelo 300 mg concentrate for solution for infusion

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
changes in inflammatory cell composition and gene expression profiles in skin and blood samples.	—

Secondary

Measure	Time frame
the impact of anifriolumab therapy on the clinical course of patients with cutaneous lupus erythematosus.	—

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 8, 2026