Идёт набор NCT07449702

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Фаза II 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: ORKA-001.
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
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

An Open-label Extension Study to Evaluate the Long-term Safety, Tolerability, and Efficacy of ORKA-001 in Participants With Moderate-to-Severe Plaque Psoriasis

Обзор

An open-label extension (OLE) study to evaluate the long-term safety and efficacy of ORKA-001 in adult participants with moderate-to-severe plaque psoriasis, who previously participated in an Oruka Therapeutics sponsored study.

Подробное описание

This open-label extension study evaluates the long-term safety and efficacy of ORKA-001 in adults with moderate-to-severe plaque psoriasis. The study includes an open-label treatment period of up to approximately 96 weeks and a post-treatment follow-up period of approximately 48 weeks following the last study visit.

Вмешательства

Препарат ORKA-001
ORKA-001 administered by subcutaneous (SC) injection

Первичные конечные точки

Incidence of Treatment-emergent Adverse Events (TEAEs), Treatment-emergent Serious Adverse Events (TESAEs), and TEAEs of Special Interest (TEAESIs) [Срок оценки: Day 1 through Week 144]

Вторичные конечные точки (9)

Proportion of Participants Maintaining PASI100 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Срок оценки: Day 1 through Week 96]
Proportion of Participants Maintaining PASI90 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Срок оценки: Day 1 through Week 96]
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Срок оценки: Day 1 through Week 96]
Proportion of Participants Maintaining Investigator's Global Assessment (IGA) 0/1 in the Subset of Participants Meeting the Criterion at Baseline of OLE [Срок оценки: Time Frame: Day 1 through Week 96]
Proportion of Participants with an Improvement of their OLE Baseline PASI Score in the Subset of Participants who did not Achieve PASI75 at OLE Baseline [Срок оценки: Day 1 through Week 96]
Time-to-loss of PASI100 in the Subset of Participants who achieved PASI100 at Baseline of OLE [Срок оценки: Day 1 through Week 96]
Time-to-loss of PASI90 in the Subset of Participants who achieved PASI90 at Baseline of the OLE [Срок оценки: Day 1 through Week 96]
PASI Score Over Time [Срок оценки: Day 1 through Week 96]
IGA Score Over Time [Срок оценки: Day 1 through Week 96]

Критерии участия

Критерии включения

Signed informed consent by participants from previous trial choosing to transition into the OLE.
Participants who have successfully completed the preceding trial.
For women of childbearing potential, must have a negative urine pregnancy test at Baseline visit.
For women of childbearing potential and fertile male participants with a partner of childbearing potential must be willing to continue to use highly effective contraception

Критерии исключения

Participants who experienced any adverse events with ORKA-001 in the preceding trial that led to permanent investigational medicinal product discontinuation or, in the opinion of the Investigator, would preclude continued treatment with ORKA-001
Participants who have developed guttate, erythrodermic or pustular psoriasis or drug-induced psoriasis (as diagnosed by the Investigator), during the preceding trial.
Evidence of current or previous clinically significant disease, medical condition other than psoriasis, or finding during the medical examination that, in the opinion of the Investigator would compromise the safety of the participant or the quality of the data.
Any clinically significant laboratory abnormality based on the last available lab results received during the preceding trial, that, according to the Investigator's medical assessment, precludes them from continued treatment with ORKA-001.
Participant is pregnant or breastfeeding.

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

Здоровые добровольцы: Нет