Correction of Psoriatic T Cell Signatures by Deucravacitinib

Phase 4

Recruiting

• Conditions: Psoriasis Vulgaris
• Interventions: Drug: deucravacitinib

• Registration Number: NCT05858645
• Lead Sponsor: University of California, San Francisco

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.

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 Timeline

• Study First Submitted: 2023-05-04
• Study First Submitted QC: 2023-05-04
• Study First Posted: 2023-05-15
• Study Start: 2023-10-01
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-25
• Last Update Posted: 2024-06-27
• Primary Completion: 2026-06
• Study Completion: 2026-06

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 25

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
deucravacitinib treatment	deucravacitinib	treatment with deucravacitinib for 6 months

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

University of California, San Francisco; 🇺🇸 San Francisco, California, United States