Идёт набор NCT06855498

Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Фаза III С лечением Hidradenitis Suppurativa (HS)

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: povorcitinib.
Кому может быть актуально: Состояния в реестре: Hidradenitis Suppurativa (HS). 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, Австрия, Бельгия +15
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Официальное название

A Phase 3b, Multicenter, Rollover Study for Participants Previously Enrolled in Clinical Trials of Povorcitinib

Rollover study for participants from predetermined, Incyte-sponsored parent clinical trials of povorcitinib.

Препарат povorcitinib
Study drug will be taken orally as defined by the protocol.

Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Up to approximately 3 years]

Вторичные конечные точки (1)

Proportion of participants with a total ANdT count of 0, 1, or 2 at each visit [Срок оценки: Up to approximately 3 years]

Ability to comprehend and willingness to sign a written ICF for the study.
Completed the treatment period of a predetermined, Incyte-sponsored, povorcitinib parent study without safety or tolerability concerns, per investigator's assessment.
Received clinical benefit from treatment with study drug during the parent study, as determined by the investigator.
Demonstrated compliance, as assessed by the investigator, with the parent Protocol requirements.
Willingness to avoid pregnancy or fathering children as defined in the protocol.
Willingness and ability to comply with the study Protocol and procedures.

Had been permanently discontinued from study treatment during the parent study.
Had temporary study drug interruption due to safety and/or efficacy reasons at or after the final visit of the parent study.
Received at least 1 dose of either of the following therapies within the 28 days prior to starting treatment in this rollover study:

Biologic immunomodulator (examples include but are not limited to adalimumab, bimekizumab, dupilumab, infliximab, nemolizumab, secukinumab).
Live, attenuated vaccine.
Plans for administration of a live, attenuated vaccine during this study or within 8 weeks after the last dose of study drug.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Known hypersensitivity or severe reaction to povorcitinib or excipients of povorcitinib and/or other products in the same class.
Currently enrolled in any other clinical study involving an investigational product or any other type of medical research judged not to be scientifically or medically compatible with this study.
Any condition that would, in the investigator's and/or sponsor's judgment, interfere with full participation in the study, including administration of study drug and attending required study visits; pose a significant risk to the participant; or interfere with interpretation of study data.

Other protocol-defined Inclusion/Exclusion Criteria may apply.

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

Здоровые добровольцы: Нет