NCT05858645

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
25

participants targeted

Target at below P25 for phase_4

Timeline
0mo left

Started Oct 2023

Typical duration for phase_4

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress99%
Oct 2023Jun 2026

First Submitted

Initial submission to the registry

May 4, 2023

Completed
11 days until next milestone

First Posted

Study publicly available on registry

May 15, 2023

Completed
5 months until next milestone

Study Start

First participant enrolled

October 1, 2023

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2026

Last Updated

June 27, 2024

Status Verified

June 1, 2024

Enrollment Period

2.7 years

First QC Date

May 4, 2023

Last Update Submit

June 25, 2024

Conditions

Psoriasis Vulgaris

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (1)

deucravacitinib treatment

EXPERIMENTAL

treatment with deucravacitinib for 6 months

Drug: deucravacitinib

Interventions

deucravacitinibDRUG

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

deucravacitinib treatment

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Francisco

San Francisco, California, 94115, United States

RECRUITING

MeSH Terms

Interventions

deucravacitinib

Study Officials

  • Raymond Cho, MD, PhD

    University of California, San Francisco

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Raymond Cho, MD, PhD

CONTACT

415 575 0524rashes@ucsf.edu

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 4, 2023

First Posted

May 15, 2023

Study Start

October 1, 2023

Primary Completion (Estimated)

June 1, 2026

Study Completion (Estimated)

June 1, 2026

Last Updated

June 27, 2024

Record last verified: 2024-06

Data Sharing

IPD Sharing
Will not share

Locations

US(1)