Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

Официальное название

A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis

Обзор

This study is a single-center, single-arm, open-label, exploratory clinical trial. A total of 30 patients with diffuse cutaneous systemic sclerosis (dcSSc) will be enrolled. A historical control cohort will be established to evaluate the efficacy and safety of Firsekibart by comparing with historical data.

Вмешательства

• Препарат Firsekibart injection
  Firsekibart, independently developed by GeneScience, was officially approved for marketing by the NMPA in July 2025 as China's first domestically developed fully human monoclonal antibody targeting IL-1β.

Первичные конечные точки

• Change in the modified Rodnan Skin Score (mRSS) from baseline [Срок оценки: Week 12]

Вторичные конечные точки (6)

• Change in modified Rodnan skin score (mRSS) from baseline [Срок оценки: Week 16, 24]
• Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline [Срок оценки: Week 12, 16, 24]
• Change from baseline in pulmonary function (FVC) [Срок оценки: Week 12, 16, 24]
• Change from baseline in pulmonary function (DLCO) [Срок оценки: Week 12, 16, 24]
• Change in serum IL-1β levels from baseline [Срок оценки: Week 12, 16, 24]
• Change in serum IL-6 levels from baseline [Срок оценки: Week 12, 16, 24]

Критерии участия

Критерии включения

• Age 18-70 years (inclusive), male or female.
• Diagnosis of systemic sclerosis (SSc) according to the 2013 ACR/EULAR diagnostic criteria.
• Disease duration of diffuse cutaneous systemic sclerosis (dcSSc), as defined by LeRoy \& Medsger (2001), of ≤ 5 years (from the time of first onset of non-Raynaud's phenomenon).
• Modified Rodnan skin score (mRSS) ≥10;
• Voluntarily signed informed consent form and ability to comply with the requirements of the study protocol.

Критерии исключения

• Allergy to the active ingredient of Firsekibart or any of its excipients, or a history of allergy to monoclonal antibodies.
• Presence of any rheumatic disease other than SSc.
• Moderate to severe lung disease with FVC < 60% or DLCO < 50% of predicted value.
• Use of medications that may interfere with the evaluation of the efficacy and safety of Firsekibart, except for stable use of permitted concomitant therapies that have been maintained for at least 4 weeks prior to screening and are kept at a stable dose throughout the study period.
• Use of biological agents or stem cell therapy within 3 months prior to screening or within 5 half-lives of the known drug.
• Receipt of live or attenuated vaccines within two months prior to screening.
• Severe hepatic impairment, renal impairment, or hematologic abnormalities at screening.
• Acute or chronic infection (excluding infection complicated by finger ulceration), active infection, history of malignant tumor, or immunodeficiency disorder.
• Women who are pregnant or breastfeeding, or subjects planning to become pregnant during the study period.
• Any other conditions that, in the investigator's judgment, render the subject ineligible for this trial.

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

• Tongji Hospital, Tong ji Medical Colledge — Ухань

Идентификаторы

NCT: NCT07502105 · TJ-IRB202601060

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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