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Набор скоро начнётся NCT07547813

A Proof-of-Concept Study of LAD328 in Adults With Hidradenitis Suppurativa

Фаза II С лечением Hidradenitis Suppurativa

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: LAD328, Placebo.
Кому может быть актуально
Состояния в реестре: Hidradenitis Suppurativa. Базовые параметры: 18 лет — 65 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
Список центров уточняется — проверьте первичный протокол.
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, Randomized, Placebo-controlled, Double-blind Clinical Study to Evaluate Efficacy and Safety of LAD328 in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa

Обзор

The main purpose of this study is to evaluate the effect of LAD328 compared to placebo in participants with moderate-to-severe Hidradenitis Suppurativa (HS), and to access the safety, tolerability, pharmacokinetic and immunogenicity in participants with moderate-to-severe HS.

Подробное описание

Hidradenitis suppurativa (HS) is a chronic skin disease of unclear etiology that affects approximately 1% of the general population.

The purpose of this study is to assess the efficacy of LAD328 compared to placebo in participants with moderate-to-severe HS.

The study participants will be randomized to one of the following treatment arms: LAD328 or Placebo.

The study includes up to 4 weeks screening period 12-week double-blind, placebo-controlled period and 8-week safety follow-up.

The total duration of study participation will be up to 20 weeks

Вмешательства

  • Препарат LAD328
    LAD328 administered intravenously.
  • Другое Placebo
    Placebo administered intravenously.

Первичные конечные точки

  • Proportion of Participants Achieving 55 Percent (%) Reduction from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4-55) [Срок оценки: At Week 12]
Вторичные конечные точки (5)
  • Proportion of Participants Achieving 50% Reduction from Baseline in Hidradenitis Suppurativa Clinical Response (HiSCR50) [Срок оценки: At Week 12]
  • Proportion of Participants Achieving 75% Reduction from Baseline in HiSCR-75 [Срок оценки: At Week 12]
  • Proportion of Participants Achieving 90% Reduction from Baseline in HiSCR-90 [Срок оценки: At Week 12]
  • Change from Baseline in Skin Pain Numerical Rating Scale (NRS) [Срок оценки: At Week 12]
  • Change from Baseline in Hidradenitis Suppurativa Quality of Life (HiSQOL) [Срок оценки: At Week 12]

Критерии участия

Критерии включения

  • Male or female between 18 and 65 years old inclusive.
  • A diagnosis of moderate-to-severe HS defined as a total of >=5 inflammatory lesions (i.e., number of abscesses plus number of inflammatory nodules) at both the Screening and Baseline visits, with a clinical history of HS for at least 6 months.
  • HS lesions present in at least 2 distinct anatomic areas (e.g., left and right axilla), one of which must be at least Hurley Stage II or Hurley Stage III at both the Screening and Baseline visits.
  • History of inadequate response, or intolerance or contraindication, to a course of a systemic antibiotics for treatment of HS at the Screening visit.
  • Agree to regularly use, over-the-counter topical antiseptics on their HS lesions throughout the entirety of the study.
  • Participants who are woman of child-bearing potential (WOCBP) and male participants must agree to the requirements for the avoidance of pregnancy and exposure of the participant's partner to LAD328 during the trial.

Критерии исключения

  • HS with >20 draining tunnels either at the Screening or Baseline visits.
  • Ongoing medical conditions (e.g., inflammatory bowel disease, rheumatoid arthritis, systemic lupus erythematosus and sarcoidosis) requiring systemic immunosuppressive/immunomodulating treatments (e.g., methotrexate, ciclosporin, corticosteroids, cytokine-targeted therapy and JAK inhibitors) during the trial.
  • Known or suspected hypersensitivity to trial product or any of its excipients.
  • Hypersensitivity or systemic reaction to a prior biologic (antibody-based) therapy (regardless of indication), that was clinically significant, as per judgment of Investigator.
  • Prior treatment with LAD328.
  • Live and attenuated vaccinations 4 weeks prior Pre-treatment or is planning to receive any such vaccine during the trial.
  • Females who are pregnant or breast-feeding or seeking to become pregnant during the trial.

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
Четверное слепое
Основная цель
Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07547813 · M-00401-10 · 2025-521865-29-00

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗