Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe 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: ORKA-001, Placebo.
- Кому может быть актуально
- Состояния в реестре: Plaque Psoriasis. 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, Канада, Германия, Испания
- 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-blinded, Placebo-controlled, Dose-range Finding Study of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis
Обзор
This is a multicenter, randomized, double-blinded, placebo-controlled, dose-range finding study to evaluate the efficacy and safety of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis.
Подробное описание
This is a multicenter, randomized, double-blinded, placebo-controlled, dose ranging study designed to identify the optimal induction dosing regimen of ORKA-001 in approximately 160 adult participants with moderate-to-severe plaque psoriasis.
The study will evaluate the efficacy and safety of 3 induction dosing regimens of ORKA-001 compared to placebo and will include 3 maintenance regimens.
The study will consist of 4 periods:
* Screening Period of up to 6 weeks * Induction Period of up to 28 weeks (Day 1 \[Baseline\] to Week 28) * Maintenance Period of up to approximately 72 weeks (Week 28 to Week 100) * Post-treatment Follow-up Period: Participants will have the option to enter the open-label extension (OLE) study. Participants who opt out of the OLE study and/or withdraw from the study must be followed for 48 weeks after the End of Treatment (EOT)/Early Termination (ET) visit.
Вмешательства
- Препарат ORKA-001
ORKA-001 administered by subcutaneous (SC) injection - Другое Placebo
Placebo administered by subcutaneous (SC) injection
Первичные конечные точки
- Proportion of Participants Achieving 100% Reduction in PASI Score at Week 16 [Срок оценки: Week 16]
Вторичные конечные точки (9)
- Proportion of Participants Who Achieve an IGA = 0 (Clear) at Week 16 [Срок оценки: Week 16]
- Proportion of Participants Achieving 90% Reduction in PASI Score at Week 16 [Срок оценки: Week 16]
- Proportion of Participants Who Achieve an IGA = 0 (Clear) or 1 (Almost Clear) at Week 16 [Срок оценки: Week 16]
- Proportion of Participants Maintaining 100% Reduction in PASI Score at Week 100 [Срок оценки: Week 100]
- Proportion of Participants Maintaining an IGA = 0 (Clear) at Week 100 [Срок оценки: Week 100]
- Proportion of Participants Maintaining 90% Reduction in PASI Score at Week 100 [Срок оценки: Week 100]
- Proportion of Participants Maintaining an IGA = 0 (Clear) or 1 (Almost Clear) at Week 100 [Срок оценки: Week 100]
- Proportion of Participants Maintaining 75% Reduction in PASI Score at Week 100 [Срок оценки: Week 100]
- Incidence of Treatment-emergent Adverse Events (TEAEs) and TEAEs of Special Interest (TEAESIs) [Срок оценки: Day 1 through Week 100]
Критерии участия
Критерии включения
- Participants ≥ 18 years of age
- Have a diagnosis of plaque psoriasis for > 6 months
- Have moderate-to-severe chronic plaque psoriasis defined as:
- BSA ≥ 10%, and
- PASI ≥ 12, and
- IGA score of ≥ 3 on a 5-point scale
- Candidate for systemic therapy or phototherapy
- Women of childbearing potential must have a negative pregnancy test.
Критерии исключения
- Nonplaque forms of psoriasis (including guttate, erythrodermic, or pustular) or drug-induced psoriasis
- Significant history or clinical manifestation of any metabolic, other dermatological, hepatic, renal, hematologic, pulmonary, cardiovascular, gastrointestinal, neurologic, respiratory, endocrine, or psychiatric disorder, or any infectious disease
- History of malignancy, except for non-melanoma skin cancer or cancer curatively treated ≥ 5 years, without evidence of recurrence
- A known hypersensitivity to any components of the ORKA-001 drug product
- Women who are breastfeeding or plan to breastfeed during the study
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 · 20 центров
- Oruka Therapeutics Investigative Site — Phoenix
- Oruka Therapeutics Investigative Site — North Little Rock
- Oruka Therapeutics Investigative Site — Los Angeles
- Oruka Therapeutics Investigative Site — Los Angeles
- Oruka Therapeutics Investigative Site — San Diego
- Oruka Therapeutics Investigative Site — Miami
- Oruka Therapeutics Investigative Site — Rolling Meadows
- Oruka Therapeutics Investigative Site — Plainfield
- … и ещё 12 центров
Канада · 8 центров
- Oruka Therapeutics Investigative Site — Surrey
- Oruka Therapeutics Investigative Site — Surrey
- Oruka Therapeutics Investigative Site — Fredericton
- Oruka Therapeutics Investigative Site — Ajax
- Oruka Therapeutics Investigative Site — Markham
- Oruka Therapeutics Investigative Site — Peterborough
- Oruka Therapeutics Investigative Site — Montreal
- Oruka Therapeutics Investigative Site — Québec
Германия · 4 центра
- Oruka Therapeutics Investigative Site — Heidelberg
- Oruka Therapeutics Investigative Site — Frankfurt am Main
- Oruka Therapeutics Investigative Site — Bad Bentheim
- Oruka Therapeutics Investigative Site — Kiel
Испания · 4 центра
- Oruka Therapeutics Investigative Site — Badalona
- Oruka Therapeutics Investigative Site — Barcelona
- Oruka Therapeutics Investigative Site — Madrid
- Oruka Therapeutics Investigative Site — Madrid
Идентификаторы
NCT: NCT07290569 · ORKA-001-114