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Clinical Trials List

Protocol NumberIM0111130
Active

2025-11-01 - 2030-06-07

Others

Not yet recruiting5

Recruiting2

ICD-10L40.0

Psoriasis vulgaris

ICD-10L40.1

Generalized pustular psoriasis

ICD-10L40.2

Acrodermatitis continua

ICD-10L40.3

Pustulosis palmaris et plantaris

ICD-10L40.4

Guttate psoriasis

ICD-10L40.8

Other psoriasis

ICD-10L40.9

Psoriasis, unspecified

ICD-9696.1

Other psoriasis

A phase 3b/4, multicenter, randomized, open-label, long-term safety trial comparing deucravacitinib with ustekinumab in participants with moderate to severe plaque psoriasis (PRAGMATYK).

  • Trial Applicant

    BRISTOL-MYERS SQUIBB (TAIWAN) LTD.

  • Sponsor

    Bristol-Myers Squibb Taiwan Co., Ltd.

  • Trial scale

    Multi-Regional Multi-Center

  • Update

    2026/07/06

Investigators and Locations

Principal Investigator 何宜承

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 洪千惠

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator TSEN-FANG TSAI

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator Yun-Ting Chang

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Principal Investigator 蔡雅竹

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

Principal Investigator 吳南霖

Co-Principal Investigator

The Actual Total Number of Participants Enrolled

0 Recruiting

The Actual Total Number of Participants Enrolled

0 Not yet recruiting

Condition/Disease

Participants with moderate to severe plaque psoriasis (PRAGMATYK)

Objectives

The purpose of this trial is to help us further understand the safety and efficacy of Deucravacitinib for the treatment of psoriasis.

Test Drug

Shu Ting Coated Tablets 6 mg

Active Ingredient

Deucravacitinib

Dosage Form

Film-coated tablets

Dosage

6 MG

Endpoints

The composite cardiovascular test index is defined as: three major adverse cardiovascular events (MACEs) as determined (non-fatal myocardial infarction [MI], non-fatal stroke, and cardiovascular death) plus coronary revascularization.

Inclution Criteria

1. Participants with moderate to severe plaque psoriasis who are eligible for phototherapy or systemic treatment; defined as having a Psoriasis Area and Severity Index (PASI) ≥ 12, Body Surface Area (BSA) ≥ 10%, and Static Physician Overall Assessment (sPGA) ≥ 3 at the screening follow-up visit and Day 1.

2. At the screening follow-up visit, participants must have at least one of the following cardiovascular risk factors:

- Currently a smoker.

Note: E-cigarettes are not considered smoking.

- Diagnosed with hypertension (defined as blood pressure ≥ 130/90 mm Hg) or using antihypertensive medication.

- Diagnosed with dyslipidemia (defined as total cholesterol ≥ 240 mg/dL, or LDL cholesterol ≥ 160 mg/dL, or HDL cholesterol < 40 mg/dL for men (as determined at birth) and < 50 mg/dL for women (as determined at birth), or using lipid-lowering medication [such as statins]).

- Type 1 or 2 diabetes.

- History of one or more of the following cardiovascular events: coronary revascularization (including percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]), myocardial infarction, cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack. - Obesity, defined as a body mass index ≥ 30 kg/m2.

- Family history of premature coronary heart disease (defined as: a first-degree male relative (sex at birth) under 55 years of age, or a first-degree female relative (sex at birth) under 65 years of age, who has had clinical coronary artery disease or sudden death.

3. You must be at least 40 years old.

Exclusion Criteria

1. Participants meeting any of the following exclusion criteria will not be included in the trial:

- Recent occurrence of one of the following cardiovascular events: myocardial infarction, stroke, coronary revascularization, or venous thromboembolism within 90 days prior to Day 1.

- Unstable cardiovascular disease, defined as: a recent clinical cardiovascular event (e.g., unstable angina, rapid atrial fibrillation) or hospitalization for heart problems (e.g., implantation of a pacemaker, heart failure) within 90 days prior to Day 1.

- Evidence of active cancer, or a history of cancer (solid organ or hematologic malignancy, including myelodysplastic syndrome) or lymphoproliferative disorder (excluding resected basal cell carcinoma or squamous cell carcinoma of the skin, or treated cervical carcinoma in situ without evidence of recurrence) within the past 5 years.

The Estimated Number of Participants

  • Taiwan

    100 participants

  • Global

    3040 participants