NCT07502105尚未招募不适用
A Single-Centre, Single-Arm Study on the Efficacy and Safety of Firsekibart in the Treatment of Systemic Sclerosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Change in the modified Rodnan Skin Score (mRSS) from baseline
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究组 & 干预措施
Firsekibart injection
Experimental
Eligible participants will be enrolled and receive Firsekibart 200 mg administered subcutaneously at weeks 0, 4, and 8.
干预措施: Firsekibart injection (Drug)
结局指标
主要结局
Change in the modified Rodnan Skin Score (mRSS) from baseline
时间窗: Week 12
The mRSS is independently assessed by two physicians, evaluating the thickness of skin in 17 anatomic areas rated from 0 to 3, with a total score ranging from 0 to 51.
次要结局
- Change in modified Rodnan skin score (mRSS) from baseline(Week 16, 24)
- Change in the Composite Response Index in Systemic Sclerosis (CRISS) from baseline(Week 12, 16, 24)
- Change from baseline in pulmonary function (FVC)(Week 12, 16, 24)
- Change from baseline in pulmonary function (DLCO)(Week 12, 16, 24)
- Change in serum IL-1β levels from baseline(Week 12, 16, 24)
- Change in serum IL-6 levels from baseline(Week 12, 16, 24)
研究者
Lingli Dong
professor; professor of medicine
Tongji Hospital
研究点 (1)
Loading locations...
相似试验
招募中
2 期
Efficacy and Safety of Neoadjuvant Envafolimab Combined With Albumin-bound Paclitaxel and Carboplatin for Resectable Locally Advanced Esophageal Squamous Cell CarcinomaNCT07266493Shanghai Zhongshan Hospital26
招募中
不适用
Efficacy and Safety of Transcranial Temporal Interference Stimulation (tTIS) for Neuropathic Pain in Neuromyelitis Optica Spectrum Disorder (NMOSD)NCT07377305Tang-Du Hospital12
尚未招募
2 期
A Prospective, Single-Arm, Exploratory Study of IBI363 in ES-SCLC Patients After Immunotherapy ProgressionNCT07289048Union Hospital, Tongji Medical College, Huazhong University of Science and Technology35
尚未招募
2 期
the Efficacy of Leucogen in Preventing the Risk of Ribociclib-Associated Neutropenia in Early Breast CancerBreast CancerNCT07380646Second Affiliated Hospital, School of Medicine, Zhejiang University94
尚未招募
4 期
A Clinical Study of Iparomlimab and Tuvonralimab Combined With SOX Following Heterogeneous Radiotherapy as First-line Treatment for Unresectable Locally Advanced or Metastatic HER2-negative Gastric or Gastroesophageal Junction AdenocarcinomaGastric Cancer (Diagnosis)Gastric Cancer (GC)Gastroesophageal Junction AdenocarcinomaNCT07502027Huazhong University of Science and Technology55