Back to resultsCorrection of Psoriatic T Cell Signatures by Deucravacitinib
Primary Purpose
Psoriasis Vulgaris
Status
Not yet recruiting
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
deucravacitinib
Sponsored by
About this trial
This is an interventional basic science trial for Psoriasis Vulgaris
Eligibility Criteria
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.
Sites / Locations
- University of California, San Francisco
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
deucravacitinib treatment
Arm Description
treatment with deucravacitinib for 6 months
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
NCT ID
NCT05858645
First Posted
May 4, 2023
Last Updated
May 4, 2023
Sponsor
University of California, San Francisco
Collaborators
Bristol-Myers Squibb
1. Study Identification
Unique Protocol Identification Number
NCT05858645
Brief Title
Correction of Psoriatic T Cell Signatures by Deucravacitinib
Official Title
Correction of Psoriatic T Cell Signatures by Deucravacitinib
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Not yet recruiting
Study Start Date
July 2023 (Anticipated)
Primary Completion Date
June 2026 (Anticipated)
Study Completion Date
June 2026 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of California, San Francisco
Collaborators
Bristol-Myers Squibb
4. Oversight
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
Data Monitoring Committee
No
5. 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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Psoriasis Vulgaris
7. Study Design
Primary Purpose
Basic Science
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
25 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
deucravacitinib treatment
Arm Type
Experimental
Arm Description
treatment with deucravacitinib for 6 months
Intervention Type
Drug
Intervention Name(s)
deucravacitinib
Intervention Description
Treatment with deucravacitinib, skin biopsy and blood analysis pre- and mid-treatment
Primary Outcome Measure Information:
Title
Change in Psoriasis Area and Severity Index (PASI) score
Description
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
Time Frame
pre-treatment, 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Raymond Cho, MD, PhD
Phone
415 575 0524
Email
rashes@ucsf.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond Cho, MD, PhD
Organizational Affiliation
University of California, San Francisco
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of California, San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ray Cho, MD, PhD
Phone
415-575-0524
Email
rashes@ucsf.edu
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Correction of Psoriatic T Cell Signatures by Deucravacitinib
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