Меню
Идёт набор NCT06895499

Efficacy, Safety, and Tolerability of HB0043 in Hidradenitis Suppurativa Patients.

Фаза I / 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: HB0043, HB0043, HB0043.
Кому может быть актуально
Состояния в реестре: Hidradenitis Suppurativa. 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
Китай
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

Не всё понятно в терминах? Прочитайте наш гид для пациентов →

Официальное название

A Phase I/II, Open-Label, Dose-Escalation Clinical Trial to Evaluate the Safety and Efficacy of HB0043 (Bispecific Antibody Targeting IL-17A and IL-36R) in Adult Patients With Moderate to Severe Hidradenitis Suppurativa (HS).

Обзор

The purpose of this study is to assess efficacy safety and tolerability of HB0043 in adult patients with moderate to severe HS.

Подробное описание

The total duration of the study is 28 weeks and consists of: Screening (up to 4 weeks), Treatment Period (20 weeks) and Safety Follow-Up (treatment-free follow-up for 4 weeks).

Participants who prematurely discontinue study treatment are encouraged to remain in the study. Participants who do not wish to remain in the study will enter a 4-week Safety Follow-Up period.

Вмешательства

  • Препарат HB0043
    Low dose
  • Препарат HB0043
    Medium dose
  • Препарат HB0043
    High dose

Первичные конечные точки

  • Safety and Tolerability of HB0043 in Patients with Moderate to Severe HS [Срок оценки: From randomization to end of study, assessed up to 24 weeks.]
Вторичные конечные точки (12)
  • Percentage of participants achieving HiSCR [Срок оценки: Week 16 and 24]
  • Change From Baseline in Inflammatory Lesion (Abscesses and Inflammatory Nodules) Count [Срок оценки: Week 16 and 24]
  • Change From Baseline in the number of lesions [Срок оценки: Week 16 and 24]
  • Percentage of Participants Achieving ≥ 30% Reduction and ≥ 1 Unit Reduction From Baseline in PGA-NRS [Срок оценки: Week 16 and 24]
  • Percentage of participants achieving HiSCR75 [Срок оценки: Week 16 and 24]
  • Change in absolute score from Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) [Срок оценки: Week 16 and 24]
  • Serum HB0043 concentrations throughout the study [Срок оценки: From randomization to end of study, assessed up to 24 weeks.]
  • Incidence of anti-HB0043 antibody positive response throughout the study [Срок оценки: From randomization to end of study, assessed up to 24 weeks.]
  • Percentage of participants achieving HiSCR90 [Срок оценки: Week 16 and 24]
  • Percentage of participants achieving HiSCR100 [Срок оценки: Week 16 and 24]
  • Change of the most severe Patient's Global Assessment of Skin Pain (PGA Skin Pain) within the past 24 hours [Срок оценки: Week 16 and 24]
  • Dermatology Life Quality Index (DLQI) [Срок оценки: Week 16 and 24]

Критерии участия

Критерии включения

  • 1\. Understand the research procedure of this study and provide written informed consent; 2. Male or female, age 18 years or greater; 3. Diagnosis of HS with a disease duration of at least 6 months before screening; 4. Moderate to severe HS, concurrently meeting the following three criteria:
  • HS lesions in at least 2 distinct anatomic area;
  • One of the HS lesions must be Hurley Stage II or Hurley Stage III;
  • Total abscess and inflammatory nodule (AN) count of greater than or equal to 3; 5. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including six months of follow-up.

Критерии исключения

  • 1\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Participant has a draining fistula count of ≥20 at the Screening Visit; 3. Presence of other active autoimmune diseases except HS, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 4. Participant has any other active skin disease or condition that may interfere with the assessment of hidradenitis suppurativa; 5. History of lymphoproliferative disorders or any known malignancy within five years prior to the Screening Visit (excluding treated and cured cutaneous squamous cell carcinoma, basal cell carcinoma, carcinoma uterine in situ, or intraductal breast cancer in situ); 6. History of recurrent or recent serious infection; 7. Participant has active tuberculosis (TB) or concurrent treatment for latent TB or evidence of hepatitis B virus (HBV) or hepatitis C virus (HCV) or human immunodeficiency virus (HIV) infection; 8. Pregnant or lactating women; 9. Any reason why, in the opinion of the investigator, the patient should not participate.

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

Здоровые добровольцы: Да

Дизайн исследования

Распределение
Нерандомизированное
Модель
Перекрёстный дизайн
Маскирование
Открытое
Основная цель
Лечение

Центры проведения

Китай · 1 центр
  • Dermatology Hospital affiliated to Shandong First Medical University — Цзинань

Идентификаторы

NCT: NCT06895499 · HB0043-HS-0-01

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗