A Study to Evaluate Efficacy and Safety of HB0043 in Aadult Patients With Moderate to Severe Acne Vulgaris.

Официальное название

A Phase I, Single-center, Randomized, Double-blind, Placebo-controlled 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 Acne Vulgaris (AV).

Обзор

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

Подробное описание

The total duration of the study is 18 weeks and consists of: Screening (up to 2 weeks) and Treatment Period (16 weeks).

Вмешательства

• Препарат HB0043
  300mg
• Препарат Placebo
  300mg

Первичные конечные точки

• Change in inflammatory lesion counts [Срок оценки: Week 16]
• Investigator's global assessment (IGA) - change from Baseline [Срок оценки: Week 16]

Вторичные конечные точки (5)

• Investigator's global assessment (IGA) - percentage of subjects with improvement [Срок оценки: Week 2, 4, 8, 12, 16]
• Change in inflammatory lesion counts [Срок оценки: Week 16]
• Investigator's global assessment (IGA) - percentage of subjects with improvement [Срок оценки: Week 2, 4, 8, 12, 16]
• Investigator's global assessment (IGA) - percentage of subjects with improvement [Срок оценки: Week 2, 4, 8, 12, 16]
• Incidence of AEs and serious adverse events (SAEs)) [Срок оценки: Baseline to week 16]

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. Diagnosed with mild to moderate facial acne vulgaris; 4. Throughout the study period, participants must refrain from using concomitant acne therapies.

5\. Acceptance by the patient, of childbearing age, to use safe contraceptive methods throughout the study, including 3 months of follow-up.

Критерии исключения

• 1\. Participants with known hypersensitivity to HB0043 or any of its excipients; 2. Those with facial skin or hair conditions, or with facial skin damage or abnormality that may interfere with clinical assessment.

3\. Participant has any facial skin disease other than common acne. 4. Presence of other active autoimmune diseases, including but not limited to psoriasis, psoriatic arthritis, rheumatoid arthritis, systemic lupus erythematosus, inflammatory bowel disease, and uveitis; 5. Participant has any other active skin disease or condition that may interfere with the assessment of acne vulgaris; 6. 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); 7. History of recurrent or recent serious infection; 8. 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; 9. Pregnant or lactating women; 10. 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

Рандомизированное

Модель

Перекрёстный дизайн

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Dermatology Hospital affiliated to Shandong First Medical University, — Цзинань

Идентификаторы

NCT: NCT07449156 · HB0043-AV-0-01

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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