Correction of Psoriatic T Cell Signatures by Deucravacitinib

Psoriasis Vulgaris Clinical Trial

Official title:

Correction of Psoriatic T Cell Signatures by Deucravacitinib

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05858645
• Other study ID #: 22-37660
• Status: Not yet recruiting
• Phase: Phase 4
• Start date: July 2023
• Est. completion date: June 2026

Study information

• Verified date: May 2023
• Source: University of California, San Francisco
• Contact: Raymond Cho, MD, PhD
• Phone: 415 575 0524
• Email: rashes[@]ucsf.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 25
• Est. completion date: June 2026
• Est. primary completion date: June 2026
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Psoriasis
• Psoriasis Vulgaris

Intervention

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

Locations

Country	Name	City	State
United States	University of California, San Francisco	San Francisco	California

Sponsors (2)

Lead Sponsor	Collaborator
University of California, San Francisco	Bristol-Myers Squibb

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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