Correction of Psoriatic T Cell Signatures by Deucravacitinib

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Psoriasis Vulgaris
• Intervention / Treatment: Drug: deucravacitinib

Detailed Description

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
• Enrollment (Anticipated): 25
• Phase: Phase 4

Contacts and Locations

• Study Contact: Name: Raymond Cho, MD, PhD; Phone Number: 415 575 0524; Email: rashes@ucsf.edu

Study Locations

• United States
  • California
    • San Francisco, California, United States, 94115
      • University of California, San Francisco
      • Contact: Ray Cho, MD, PhD; Phone Number: 415-575-0524; Email: rashes@ucsf.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: deucravacitinib treatment; treatment with deucravacitinib for 6 months	Drug: deucravacitinib; Treatment with deucravacitinib, skin biopsy and blood analysis pre- and mid-treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	pre-treatment, 4 months

Collaborators and Investigators

• Sponsor: University of California, San Francisco
• Collaborators: Bristol-Myers Squibb
• Investigators: Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study record dates

Study Major Dates

• Study Start (Anticipated): July 1, 2023
• Primary Completion (Anticipated): June 1, 2026
• Study Completion (Anticipated): June 1, 2026

Study Registration Dates

• First Submitted: May 4, 2023
• First Submitted That Met QC Criteria: May 4, 2023
• First Posted (Actual): May 15, 2023

Study Record Updates

• Last Update Posted (Actual): May 15, 2023
• Last Update Submitted That Met QC Criteria: May 4, 2023
• Last Verified: May 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Psoriasis
• Other Study ID Numbers: 22-37660

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No