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

ReclutandoFase 3ClinicalTrials.gov

ID: NCT07116967Tipo: INTERVENTIONALInicio: 22 de sept de 2025Fin estimado: 16 de ene de 2031

Cardiología Dermatología

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Resumen

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

Elegibilidad

Edad mínima: 40 YearsSexo: ALL

Criterios de inclusión

Participants with moderate-to-severe plaque psoriasis:
Deemed by the Investigator to be a candidate for phototherapy or systemic treatment for psoriasis, including ustekinumab;
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.

Criterios de exclusión

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).

Intervenciones

drug

Deucravacitinib

Specified dose on specified days

drug

Ustekinumab

Specified dose on specified days

Ubicaciones

Consultorios Reumatológicos Pampa

C.a.b.a., Buenos Aires, Argentina

Cristina Echeverria, Site 0201 · +5491159370000

RECRUITING

Local Institution - 0429

Buenos Aires, Buenos Aires F.D., Argentina

WITHDRAWN

Instituto de Neumonologia y Dermatologia

Buenos Aires, Buenos Aires F.D., Argentina

Paula Carolina Luna, Site 0227 · 1545404644

RECRUITING

Buenos Aires Skin S.A

Buenos Aires, C, Argentina

Matias Turienzo, Site 0032 · +541152190541

RECRUITING

STAT Research S.A.

Ciudad Autonoma Buenos Aires, C, Argentina

Claudio Greco, Site 0034 · 54 9 11 6052-3286

RECRUITING

Psoriahue

Ciudad Autonoma Buenos Aires, C, Argentina

Gabriel Magarinos, Site 0043 · +541148238755

RECRUITING

CEMEDIAB - Centro Medico Diabetologico

Ciudad Autónoma Buenos Aires, C, Argentina

Debora Kaplan, Site 0040 · +541149815688

RECRUITING

Derma Internacional S.A.

Autonomous City of Buenos Aires, Argentina

Maria Laura Galimberti, Site 0453 · 5491154583202

RECRUITING

CONEXA Investigacion Clinica S.A.

Buenos Aires, Argentina

Pablo Javier Gonzalez, Site 0061 · +541139899011

RECRUITING

Local Institution - 0474

Buenos Aires, Argentina

Site 0474

NOT_YET_RECRUITING

Instituto de Investigaciones Clínicas Córdoba S.A.

Córdoba, Argentina

Leandro Perrotat, Site 0455 · 3537332067

RECRUITING

Viviana Parra Instituto Parra Dermatología

Mendoza, Argentina

Viviana Parra, Site 0280 · 0000000000

RECRUITING

Patrocinadores

PrincipalBristol-Myers Squibb

Contactos

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

CONTACT

Clinical.Trials@bms.com 855-907-3286

First line of the email MUST contain NCT # and Site #.

CONTACT

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