Идёт набор NCT07213973

Pharmacokinetics, Safety, and Efficacy of Povorcitinib in Adolescent Participants With Moderate to Severe Hidradenitis Suppurativa

Фаза II 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: 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, 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

A Phase 2, Open-Label Study to Evaluate the Safety, Pharmacokinetics, and Efficacy of Povorcitinib in Adolescents With Moderate to Severe Hidradenitis Suppurativa

Обзор

The purpose of this study is to evaluate the pharmacokinetics, safety, and efficacy of povorcitinib in adolescent participants with moderate to severe hidradenitis suppurativa over a 54-week open-label treatment period.

Вмешательства

Препарат Povorcitinib
Oral; Tablet

Первичные конечные точки

Proportion of participants with Treatment-Emergent Adverse Events (TEAEs) [Срок оценки: Baseline through Week 54]
Apparent clearance [Срок оценки: Up to Week 24]
Apparent volume of distribution [Срок оценки: Up to Week 24]
Apparent oral absorption rate constant [Срок оценки: Up to Week 24]
Absorption lag time [Срок оценки: Up to Week 24]
Maximum plasma drug concentration at steady state [Срок оценки: Up to Week 24]
Average plasma drug concentration at steady state [Срок оценки: Up to Week 24]
Plasma concentration at steady state for the dosing interval [Срок оценки: Up to Week 24]
Time to maximum plasma concentration at steady state [Срок оценки: Up to Week 24]
Terminal half-life [Срок оценки: Up to Week 24]

Вторичные конечные точки (11)

Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 50 (HiSCR50) [Срок оценки: 54 weeks]
Proportion of participants who achieve Hidradenitis Suppurativa Clinical Response 75 (HiSCR75) [Срок оценки: 54 weeks]
Mean change from baseline in abscess count at each visit [Срок оценки: 54 weeks]
Mean percentage change from baseline in abscess count at each visit [Срок оценки: 54 weeks]
Mean change from baseline in inflammatory nodule count at each visit [Срок оценки: 54 weeks]
Mean percentage change from baseline in inflammatory nodule count at each visit [Срок оценки: 54 weeks]
Mean change from baseline in draining tunnel count at each visit [Срок оценки: 54 weeks]
Mean percentage change from baseline in draining tunnel count at each visit [Срок оценки: 54 weeks]
Proportion of participants who achieve Skin Pain Numeric Rating Scale (NRS)30 among participants with baseline Skin Pain NRS score ≥ 3 [Срок оценки: 54 weeks]
Proportion of participants with a ≥ 3-point decrease in Skin Pain NRS score among participants with baseline Skin Pain NRS score ≥ 3 [Срок оценки: 54 weeks]
Change from baseline in Children's Dermatology Life Quality Index (CDLQI) score at each visit [Срок оценки: 54 weeks]

Критерии участия

Критерии включения

Aged ≥ 12 to < 18 years at the time of informed consent/assent signing.
Body weight ≥ 30 kg at both screening and baseline visits.
Diagnosis of moderate to severe HS for at least 3 months prior to the screening visit.
Total abscess and inflammatory nodule count of at least 5 at both the screening and baseline visits.
HS lesions corresponding to refined Hurley Stage IB, IC, IIB, IIC, or III at both the screening and baseline visits.
Documented history of inadequate response to at least a 3-month course of at least 1 conventional systemic therapy (oral antibiotic or biologic drug) for HS (or demonstrated intolerance to, or have a contraindication to, a conventional systemic therapy for treatment of their HS).
Agreement to use contraception.
Willing and able to comply with the study protocol and procedures.
Further inclusion criteria apply.

Критерии исключения

Presence of > 20 draining tunnels (fistulas) at either the screening or baseline visit.
Women who are pregnant (or who are considering pregnancy) or breastfeeding.
Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q-wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator.
Laboratory values outside of the protocol-defined ranges.
Further exclusion criteria apply.

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

Здоровые добровольцы: Нет