Estudio multicéntrico, aleatorizado, doble ciego, control... | EligiMed

Estudio multicéntrico, aleatorizado, doble ciego, controlado con placebo, de fase 3, para evaluar la eficacia, seguridad y farmacocinética de deucravacitinib en participantes adolescentes (de 12 a menos de 18 años) con psoriasis en placas moderada a grave

ReclutandoFase 3ClinicalTrials.gov

ID: NCT06979453Tipo: INTERVENTIONALInicio: 3 de dic de 2025Fin estimado: 12 de ago de 2034

Resumen

El propósito de este estudio es evaluar la eficacia, la seguridad y los niveles plasmáticos de deucravacitinib (BMS-986165) en participantes adolescentes con psoriasis en placas moderada a grave.

Elegibilidad

Edad mínima: 12 YearsEdad máxima: 17 YearsSexo: ALL

Criterios de inclusión

Participants must have stable plaque psoriasis for 6 months or more prior to Screening.
Participants must have moderate to severe psoriasis defined by:.
i) Psoriasis Area and Severity Index (PASI) ≥ 12, at screening visit and Day 1.
ii) Static Physician's Global Assessment (sPGA) ≥ 3, at screening visit and Day 1.
iii) Body Surface Area (BSA) ≥ 10% involvement, at screening visit and Day 1.
\- A female (as assigned at birth) participant is eligible to participate if she is not pregnant or breastfeeding, and at least 1 of the following conditions applies:.
i) Is not an individual of childbearing potential (IOCBP).
ii) Is an IOCBP and using a contraceptive method that is highly effective (with a failure rate of \< 1% per year) during the study intervention period and for at least 3 days after discontinuation of the study intervention and agrees not to donate eggs (ova, oocytes) for the purpose of reproduction for the same period.

Criterios de exclusión

Participants must not weigh \< 30.0 kg at Screening and Day 1.
Participants must not have non-plaque psoriasis (ie, guttate, inverse, pustular, erythrodermic, or drug-induced psoriasis) or any skin condition other than plaque psoriasis that could interfere with assessments of treatment effect at Screening or Day 1.
Participants must not have a history of serious bacterial, fungal, or viral infection requiring hospitalization and intravenous (IV) antimicrobial treatment within 60 days prior to Day 1.
Participants must not have any untreated bacterial infection within 60 days prior to Day 1.
Participants must not have any ongoing evidence of chronic bacterial infection (eg, chronic pyelonephritis, chronic osteomyelitis, chronic bronchiectasis).
Participants must not have herpes simplex/zoster, active tuberculosis (TB), hepatitis C virus (HCV), hepatitis B virus (HBV), human immunodeficiency virus (HIV) infection-related exclusions.
Participants must not have received live vaccines or BCG within 60 days prior to Day 1 or plans to receive a live vaccine during the study, or within 60 days after completing study intervention.
Participants must not have had any prior exposure to deucravacitinib.
Participants must not have received any medication that is specifically prohibited.
Participants must not have a laboratory finding that is exclusionary.
Participants must not have any major illness/condition or evidence of an unstable clinical condition (eg, renal, hepatic, hematologic, gastrointestinal, endocrine, pulmonary, psychiatric, neurologic, immunologic, or local active infection/infectious illness) that, in the investigator's judgment or after consultation with the Sponsor's Medical Monitor, will substantially increase the risk to the participant if he or she participates in the study.
Participants must not have cancer or history of cancer (solid organ or hematologic including myelodysplastic syndrome) or lymphoproliferative disease within the previous 5 years.

Intervenciones

drug

Deucravacitinib

Specified dose on specified days

other

Placebo

Specified dose on specified days

Ubicaciones

Local Institution - 0115

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site 0115

NOT_YET_RECRUITING

Local Institution - 0119

Ciudad Autonoma de Buenos Aires, Buenos Aires, Argentina

Site 0119

NOT_YET_RECRUITING

Local Institution - 0149

Buenos Aires, Argentina

Site 0149

NOT_YET_RECRUITING

Local Institution - 0221

Buenos Aires, Argentina

Site 0221

NOT_YET_RECRUITING

Local Institution - 0250

Buenos Aires, Argentina

Site 0250

NOT_YET_RECRUITING

Local Institution - 0154

Buenos Aires, Argentina

Site 0154

NOT_YET_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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