Correction of Psoriatic T Cell Signatures by Deucravacitinib

Phase 4RecruitingNCT05858645

University of California, San Francisco25 enrolled

Overview

This study aims to assess cutaneous and blood immune cell function of patients with psoriasis before and after initiation of treatment with the Tyrosine kinase 2 (TYK2) blocker, deucravacitinib.

This is a one-arm, open-label study to examine the effect of deucravacitinib on cutaneous and blood immune cells of psoriatic patients. 25 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 deucravacitinib-corrected signatures.

Study Type

INTERVENTIONAL

Allocation

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Psoriasis Vulgaris

Interventions

deucravacitinibDRUG

Treatment with deucravacitinib, skin biopsy and blood analysis pre- and mid-treatment

Eligibility

Sex: ALLMin age: 18 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. 18 years of age or older 2. Patients with moderate-severe psoriasis (BSA \>= 10%, PASI \>=12, static Physician's Global Assessment (sPGA) 3 and above) Exclusion Criteria: 1. taking systemic immunosuppressives in the last 12 weeks 2. pregnancy 3. severe immunodeficiency (either from genetic or infectious causes). 4. tuberculosis or other active serious infection 5. active systemic malignancy. 6. breast-feeding 7. 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.

Locations (1)

University of California, San Francisco

San Francisco, California, United States

RECRUITING

Outcomes

Primary Outcomes

Change in Psoriasis Area and Severity Index (PASI) score

Change in severity and extent of psoriasis (calculated by Psoriasis Area and Severity Index (PASI) score); scale range of 0 to 72, 72 being maximal disease

Time frame: pre-treatment, 4 months

Central Contacts

Raymond Cho, MD, PhD

CONTACT

415 575 0524 rashes@ucsf.edu

Data from ClinicalTrials.gov

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