Summary

Eligibility
for people ages 40 years and up (full criteria)
Location
at UC Davis
Dates
study started
study ends around

Description

Summary

A study to evaluate the long-term safety of Deucravacitinib versus Ustekinumab in participants with psoriasis

Official Title

A Phase 3b/4 Multi-center, Randomized, Open-label, Long-term Safety Study of Deucravacitinib in Comparison to Ustekinumab in Participants With Moderate-to-Severe Plaque Psoriasis

Keywords

Plaque Psoriasis, Deucravacitinib, Cardiovascular risk, PRAGMATYK, Ustekinumab

Eligibility

You can join if…

Open to people ages 40 years and up

  • Participants with moderate-to-severe plaque psoriasis:
    1. Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
    2. Have at least 1 of the following cardiovascular risk factors:
  • Current cigarette smoker
  • Diagnosis of hypertension
  • Diagnosis of hyperlipidemia
  • Diabetes mellitus type 1 or 2
  • History of one or more of the following cardiovascular events: Coronary intervention (PCI) or coronary artery bypass grafting (CABG), myocardial infarction (heart attack), cardiac arrest, hospitalization for unstable angina, acute coronary syndrome, stroke, or transient ischemic attack
  • Obesity
  • Family history of premature coronary heart disease or sudden death in a first-degree male relative younger than 55 years of age or in a first-degree female relative younger than 65 years of age.

You CAN'T join if...

  • Participants must not have recent history of 1 of the following cardiovascular events: MI, stroke, or coronary revascularization, or VTE within 90 days prior to Day 1.
  • Participants must not have unstable CVD, defined as a recent clinical cardiovascular event (eg, unstable angina, rapid atrial fibrillation), or a cardiac hospitalization (eg, pacemaker implantation, HF) within 90 days prior to Day 1.
  • Participants must not have evidence of active cancer or history of cancer (solid organ or hematologic malignancy including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years (other than resected cutaneous basal cell or squamous cell carcinoma, or carcinoma of cervix in situ that has been treated with no evidence of recurrence).
  • Other protocol define inclusion/exclusion criteria apply.

Locations

  • UC Davis Dermatology Clinic accepting new patients
    Sacramento California 95816 United States
  • Clinical Science Institute accepting new patients
    Santa Monica California 90404 United States
  • Advanced Dermatology and Skin Cancer Institute - Beverly Hills accepting new patients
    Sherman Oaks California 91403 United States
  • Unison Clinical Trials accepting new patients
    Sherman Oaks California 91403 United States
  • T. Joseph Raoof MD Inc accepting new patients
    Encino California 91436 United States
  • Dermatology Research Associates - Howard Sofen, MD accepting new patients
    Los Angeles California 90045 United States
  • First OC Dermatology - Fountain Valley accepting new patients
    Fountain Valley California 92708 United States
  • Local Institution - 0192 not yet accepting patients
    Los Angeles California 90056-1660 United States
  • Local Institution - 0078 withdrawn
    San Diego California 92123-1523 United States
  • Marvel Clinical Research accepting new patients
    Huntington Beach California 92647 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Bristol-Myers Squibb
Links
BMS Clinical Trial Information BMS Clinical Trial Patient Recruiting
ID
NCT07116967
Phase
Phase 3 Psoriasis Research Study
Study Type
Interventional
Participants
Expecting 3040 study participants
Last Updated