A Study to Evaluate SHR-1139 Injection in Patients With Pyoderma Gangrenosum

Официальное название

A Phase II Clinical Study to Evaluate the Efficacy, Safety and Pharmacokinetics of SHR-1139 Injection in Adult Patients With Pyoderma Gangrenosum

Обзор

This study aims to evaluate the efficacy, safety, pharmacokinetics (PK) and immunogenicity of SHR-1139 Injection in patients with pyoderma gangrenosum.

Вмешательства

• Препарат SHR-1139 Injection
  SHR-1139 injection.

Первичные конечные точки

• The proportion of participants who achieved PGAR-100 in the target PG ulcer at any time before Week 26, with confirmation at the next consecutive study visit (at least 2 weeks later). [Срок оценки: At any time before Week 26.]

Вторичные конечные точки (4)

• The time to relapse in participants who achieved a complete response (complete closure of all PG ulcers) before Week 26. [Срок оценки: Up to 64 weeks.]
• The time to the first achievement of PGAR-100 in the target PG ulcer before Week 26. [Срок оценки: At any time before Week 26.]
• The time to the first achievement of PGAR-100 in any measurable PG ulcer before Week 26. [Срок оценки: At any time before Week 26.]
• The time to the first achievement of PGAR-100 in all measurable PG ulcers before Week 26. [Срок оценки: At any time before Week 26.]

Критерии участия

Критерии включения

• Aged ≥18 years at the time of signing the informed consent form, regardless of gender;
• Confirmed as having ulcerative pyoderma gangrenosum (PG) with a PARACELSUS score of ≥10 points at screening;
• At screening and baseline, having at least one measurable PG ulcer (defined as an ulcer with a measured area of ≥ 5 cm²);
• The participant voluntarily signs the informed consent form before the initiation of any study-related procedures, is able to communicate smoothly with the investigator, and understands and is willing to strictly comply with the requirements of this clinical study protocol to complete the study;
• Female participants of childbearing potential or male participants whose female partners are of childbearing potential have no plans for childbirth, sperm/egg donation from the time of signing the informed consent form, and voluntarily adopt highly effective contraceptive measures (including by the partner). Female participants must have a negative pregnancy test result during the screening period and before randomization and dosing, and must not be breastfeeding.

Критерии исключения

• Non-pyoderma gangrenosum (PG) diseases presenting with other ulcers or other similar skin lesions at screening;
• The measured area of the target PG ulcer exceeding 80 cm² at screening;
• Participants with chronic, non-inflammatory PG wounds or ulcers judged by the investigator to be unresponsive to immunosuppressive therapy at screening;
• Participants with active infection in the PG ulcer(s) at screening;
• A history of lymphoproliferative disorders, including lymphoma or signs and symptoms of potential lymphoproliferative diseases;
• A history of any active malignant tumor or malignant neoplasm within 5 years prior to the screening visit, except for curatively treated cutaneous squamous cell carcinoma, basal cell carcinoma, or carcinoma in situ of the uterine cervix;
• Any condition judged by the investigator to interfere with the assessment of the study drug's safety and efficacy.

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

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Китай · 1 центр

• Shandong First Medical University Affiliated Dermatology Hospital — Цзинань

Идентификаторы

NCT: NCT07444684 · SHR-1139-203

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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