Идёт набор NCT06979453

A Study to Evaluate the Efficacy, Safety, and Drug Levels of Deucravacitinib (BMS-986165) in Adolescent Participants With Moderate to Severe Plaque Psoriasis

Фаза III С лечением Plaque Psoriasis

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Deucravacitinib, Placebo.
Кому может быть актуально: Состояния в реестре: Plaque Psoriasis. Базовые параметры: 12 лет — 17 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Бельгия, Бразилия, Канада +11
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Multicenter, Randomized, Double-blind, Placebo-controlled Phase 3 Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Deucravacitinib in Adolescent Participants (12 Years to Less Than 18 Years) With Moderate to Severe Plaque Psoriasis

Обзор

The purpose of this study is to evaluate the efficacy, safety, and drug levels of Deucravacitinib (BMS-986165) in adolescent participants with moderate to severe plaque psoriasis

Вмешательства

Препарат Deucravacitinib
Specified dose on specified days
Другое Placebo
Specified dose on specified days

Первичные конечные точки

Number of participants achieving at least 75% improvement in Psoriasis Area and Severity Index (PASI 75) [Срок оценки: At week 16]
Number of participants achieving a static Physicians Global Assessment (sPGA) score of 0 (clear) or 1 (almost clear) with at least a 2-point reduction from baseline [Срок оценки: At week 16]

Вторичные конечные точки (12)

Number of participants achieving at least 90% improvement in PASI (PASI 90) [Срок оценки: At week 16]
Change from baseline in PASI [Срок оценки: At week 16]
Change from baseline in body surface area (BSA) involvement [Срок оценки: At week 16]
Change from baseline in worst itch numeric rating scale (WI-NRS) [Срок оценки: At week 16]
Number of participants achieving ≥ 4 improvement from baseline in the WI-NRS score (in participants with baseline score ≥ 4) [Срок оценки: At week 16]
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score [Срок оценки: At week 16]
Number of participants achieving CDLQI 0/1 (among participants with a baseline CDLQI score ≥ 2) [Срок оценки: At week 16]
Number of participants with treatment emergent adverse events [Срок оценки: Up to 5 years]
Number of participants with serious adverse events [Срок оценки: Up to 5 years]
Number of participants with clinically significant changes in laboratory parameters [Срок оценки: Up to 5 years]
Number of participants with clinically significant changes in physical examinations [Срок оценки: Up to 5 years]
Number of participants with clinically significant changes in vital signs [Срок оценки: Up to 5 years]

Критерии участия

Критерии включения

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.

Критерии исключения

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.
Other protocol-defined Inclusion/Exclusion criteria apply.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Двойное слепое
Основная цель: Лечение

Центры проведения

США · 47 центров

Local Institution - 0261 — Birmingham
Local Institution - 0041 — Birmingham
Local Institution - 0053 — Phoenix
Local Institution - 0025 — Fountain Valley
Center For Dermatology Clinical Research, Inc. — Fremont
Dermatology Research Associates — Los Angeles
Northridge Clinical Trials — Northridge
Local Institution - 0077 — Sacramento
… и ещё 39 центров

Китай · 11 центров

Beijing Children's hospital, Capital Medical University — Пекин
Peking University Third Hospital — Пекин
Guangdong Province Dermatology Hospital — Гуанчжоу
The University of Hong Kong-Shenzhen Hospital — Шэньчжэнь
The Affiliated Hospital of Hebei University of Engineering — Handan
People's Hospital of Henan Province — Чжэнчжоу
Hunan Children's Hospital — Чанша
Local Institution - 0265 — Цзинань
… и ещё 3 центра

Канада · 8 центров

Alberta Dermasurgery Centre — Edmonton
Local Institution - 0164 — Winnipeg
Skincare Studio — St. John's
DermEffects — London
The Centre for Dermatology — Richmond Hill
AvantDerm — Toronto
Local Institution - 0240 — Toronto
Local Institution - 0142 — Montreal

Польша · 8 центров