Идёт набор NCT06807424

A Study to Evaluate the Efficacy and Safety of Icotrokinra (JNJ-77242113) in Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Фаза III С лечением Arthritis, Psoriatic

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: Icotrokinra, Placebo.
Кому может быть актуально: Состояния в реестре: Arthritis, Psoriatic. Базовые параметры: от 18 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, Австралия, Бразилия, Болгария +19
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 Phase 3, Multicenter, Randomized, Double-blind, Placebo-controlled Study Evaluating the Efficacy and Safety of JNJ-77242113 for the Treatment of Biologic-experienced and Biologic-naive Participants With Active Psoriatic Arthritis

Обзор

The purpose of this study is to evaluate the efficacy of icotrokinra (JNJ-77242113) compared to placebo in biologic-experienced and biologic-naive participants with active psoriatic arthritis (PsA) by assessing the reduction in signs and symptoms of PsA.

Вмешательства

Препарат Icotrokinra
Icotrokinra will be administered.
Препарат Placebo
Placebo will be administered.

Первичные конечные точки

Proportion of Participants who Achieved an American College of Rheumatology (ACR) 20 Response at Week 16 [Срок оценки: Week 16]

Вторичные конечные точки (12)

Proportion of Participants Who Achieved Psoriatic Area and Severity Index (PASI) 75 Response at Week 16 Among Participants with Baseline Body Surface Area (BSA) Greater Than Equal to (>=) 3 Percent (%) and With Baseline IGA Score of >=2 [Срок оценки: Week 16]
Proportion of Participants Who Achieved PASI 90 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Срок оценки: Week 16]
Proportion of Participants Who Achieved PASI 100 Response at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Срок оценки: Week 16]
Proportion of Participants with an Investigator Global Assessment (IGA) Psoriasis Score of 0 or 1 And >=2 Grade Improvement From Baseline at Week 16 Among Participants with Baseline BSA >=3% and With Baseline IGA Score of >=2 [Срок оценки: Week 16]
Proportion of Participants who Achieved an ACR 50 Response at Week 16 [Срок оценки: Week 16]
Proportion of Participants who Achieved an ACR 70 Response at Week 16 [Срок оценки: Week 16]
Change From Baseline in Health Assessment Questionnaire-Disability Index (HAQ-DI) Score At Week 16 [Срок оценки: From baseline up to Week 16]
Changes From Baseline in 36 Item Short Form Survey (SF-36) Physical Component Summary (PCS) Score at Week 16 [Срок оценки: From baseline up to Week 16]
Proportion of Participants With Resolution of Enthesitis at Week 16 Among Those With Enthesitis at Baseline [Срок оценки: Week 16]
Change From Baseline in Enthesitis Score at Week 16 in Participants With Enthesitis at Baseline [Срок оценки: Baseline and Week 16]
Proportion of Participants With Resolution of Dactylitis at Week 16 Among Those With Dactylitis at Baseline [Срок оценки: Week 16]
Change From Baseline in Dactylitis Score at Week 16 in Participants With Dactylitis at Baseline [Срок оценки: From baseline up to Week 16]

Критерии участия

Критерии включения

Have active psoriatic arthritis (PsA) despite current or previous use of greater than or equal to (>=) 1 of the following: a. Non-biologic disease-modifying antirheumatic drug (DMARD) therapy; b. Apremilast therapy; c. Biologic-agent (limited to only 1)
Have a diagnosis of PsA for at least 3 months before the first administration of study intervention and meet classification criteria for Psoriatic Arthritis (CASPAR) at screening
Have active PsA as defined by: (a) At least 3 swollen joints and at least 3 tender joints at screening and at baseline (b) C-reactive protein (CRP) >= 0.1 milligrams per deciliter (mg/dL) at screening from the central laboratory
Have at least 1 of the PsA subsets: distal interphalangeal joint involvement, polyarticular arthritis with absence of rheumatoid nodules, arthritis mutilans, asymmetric peripheral arthritis, or spondylitis with peripheral arthritis
Have active plaque psoriasis with at least one psoriatic plaque of >= 2 cm diameter or nail changes consistent with psoriasis
A female participant of childbearing potential must have a negative highly sensitive serum pregnancy test (Beta-hCG) at screening and a negative urine pregnancy test at Week 0 prior to administration of study intervention

Критерии исключения

Has a history or current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, cardiac, vascular, pulmonary, gastrointestinal, endocrine, neurologic, hematologic, rheumatologic (with the exception of PsA), psychiatric, genitourinary, or metabolic disturbances
Currently has a malignancy or has a history of malignancy within 5 years prior to screening
Has known allergies, hypersensitivity, or intolerance to icotrokinra or its excipients
Has other inflammatory diseases that might confound the evaluations of benefit of icotrokinra therapy, including but not limited to rheumatoid arthritis (RA), systemic lupus erythematosus, or Lyme disease
Participants with fibromyalgia or osteoarthritis symptoms that, in the investigator's opinion, would have potential to interfere with efficacy assessments

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 · 25 центров

AARA Clinical Research — Glendale
AARA Clinical Research 1 — Mesa
Arthritis and Rheumatism Associates ARA Jonesboro — Jonesboro
Clinical Research of West Florida — Clearwater
Omega Research Consultants — DeBary
Suncoast Clinical Research — New Port Richey
Integral Rheumatology And Immunology Specialists — Plantation
Clinical Research of West Florida 1 — Tampa
… и ещё 17 центров

Китай · 25 центров

Peking University Third Hospital — Пекин
Beijing Tong Ren Hospital Capital Medical University — Пекин
The First Bethune Hospital of Jilin University — Changchun
Xiangya Hospital Central South University — Чанша
West China Hospital Sichuan University — Чэнду
Sichuan Provincial Peoples Hospital — Чэнду
The First Affiliated Hospital of Chongqing Medical University — Чунцин
Dongguan People s Hospital — Дунгуань
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Польша · 19 центров