Psoriatic Immune Response to Tildrakizumab

University of California San Francisco (UCSF)

Status and phase: Enrolling; Phase 4

Conditions: Psoriasis Vulgaris

Treatments: Drug: Tildrakizumab Prefilled Syringe

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05390515

22-36503

Details and patient eligibility

About

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the IL23 blocker, tildrakizumab.

Full description

This is a one-arm, open-label study to examine the effect of Tildrakizumab on cutaneous and blood immune cells of psoriatic patients. Ten subjects with moderate to severe psoriasis will be enrolled. Biopsy and blood samples will be collected before and during treatment and undergo molecular profiling to assess for tildrakizumab-corrected signatures.

Enrollment: 10 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• 18 years of age or older
• Patients with moderate-severe psoriasis or > 5% body surface area affected.

Exclusion criteria

• taking systemic immunosuppressives in the last 4 weeks
• pregnancy
• severe immunodeficiency (either from genetic or infectious causes).
• tuberculosis or other active serious infection
• active systemic malignancy.
• breast-feeding
• Presence of a condition or abnormality that in the opinion of the Investigator would compromise the safety of the patient or the quality of the data.

Trial design

Primary purpose: Basic Science

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

Tildrakizumab treatment

Experimental group

Description:

Biological/vaccine: tildrakizumab

Treatment:

Drug: Tildrakizumab Prefilled Syringe