Correction of Psoriatic T Cell Signatures by Deucravacitinib

Sponsor

University of California, San Francisco (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05858645

Collaborator

Bristol-Myers Squibb (Industry)

Enrollment

Location

Arm

Anticipated Duration (Months)

0.7

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease	Intervention/Treatment	Phase
Psoriasis Vulgaris	Drug: deucravacitinib	Phase 4

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 Design

Study Type:

Interventional

Anticipated Enrollment :

25 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Basic Science

Official Title:

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Anticipated Study Start Date :

Jul 1, 2023

Anticipated Primary Completion Date :

Jun 1, 2026

Anticipated Study Completion Date :

Jun 1, 2026

Arms and Interventions

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

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

Outcome Measures

Primary Outcome Measures

Change in Psoriasis Area and Severity Index (PASI) score [pre-treatment, 4 months]
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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 75 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

18 years of age or older
Patients with moderate-severe psoriasis (BSA >= 10%, PASI >=12, static Physician's Global Assessment (sPGA) 3 and above)

Exclusion Criteria:

taking systemic immunosuppressives in the last 12 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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	University of California, San Francisco	San Francisco	California	United States	94115

Sponsors and Collaborators

University of California, San Francisco
Bristol-Myers Squibb

Investigators

Principal Investigator: Raymond Cho, MD, PhD, University of California, San Francisco

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

University of California, San Francisco

ClinicalTrials.gov Identifier:

NCT05858645

Other Study ID Numbers:

22-37660

First Posted:

May 15, 2023

Last Update Posted:

May 15, 2023

Last Verified:

May 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Yes

Studies a U.S. FDA-regulated Device Product:

Product Manufactured in and Exported from the U.S.:

Additional relevant MeSH terms:

Psoriasis

Deucravacitinib

Study Results

No Results Posted as of May 15, 2023