Correction of Psoriatic T Cell Signatures by Deucravacitinib

NCT ID: NCT05858645

Last Updated: 2024-06-27

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE4

Total Enrollment

25 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-10-01

Study Completion Date

2026-06-30

Brief Summary

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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

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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.

Conditions

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Psoriasis Vulgaris

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

NONE

Study Groups

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deucravacitinib treatment

treatment with deucravacitinib for 6 months

Group Type EXPERIMENTAL

deucravacitinib

Intervention Type DRUG

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

Interventions

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deucravacitinib

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

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Bristol-Myers Squibb

INDUSTRY

Sponsor Role collaborator

University of California, San Francisco

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raymond Cho, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Francisco

Locations

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University of California, San Francisco

San Francisco, California, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Raymond Cho, MD, PhD

Role: CONTACT

415 575 0524

Facility Contacts

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Ray Cho, MD, PhD

Role: primary

415-575-0524

Other Identifiers

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22-37660

Identifier Type: -

Identifier Source: org_study_id

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