NCT07041099招募中1 期
A Phase 1b, Open-Label Study of CLN-978 for the Treatment of Active, Moderate to Severe Sjogren's Disease
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 36
- 试验地点
- 25
- 主要终点
- Safety and Tolerability
研究概览
简要总结
A phase 1b, open-label study of CLN-978 administered subcutaneously in patients with active, moderate to severe Sjogren's Disease.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Sequential
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of SjD at least 24 weeks prior to Screening Visit and meet the 2016 EULAR / ACR Classification Criteria for SjD at Screening.
- •Have active moderate to severe disease (i.e., ESSDAI ≥5) at Screening.
- •Laboratory parameters including the following:
- •Absolute lymphocyte count (ALC) ≥0.5 × 10^9/L
- •Peripheral CD19+ B cell count ≥25 cells/µL
- •Absolute neutrophil count (ANC) ≥1.0 × 10^9/L
- •Hemoglobin (Hgb) ≥8 g/dL
- •Platelet count ≥75 × 10^9/L
- •Total bilirubin ≤1.5 × ULN, except patients with confirmed Gilbert's Syndrome
- •Aspartate aminotransferase (AST) and Alanine aminotransferase (ALT) ≤2.0 × ULN
- •Estimated glomerular filtration rate (eGFR) based on the CKD-EPI formula ≥30 mL/min/1.73 m2
- •Concomitant rheumatological autoimmune disease
- •Considered at high risk for thrombosis
- •Rapidly progressive glomerulonephritis and/or urine protein/creatinine >3 mg/mg (339 mg/mmol).
- •Active, severe central nervous system manifestations of SjD.
- •History of stroke, seizure, dementia, Parkinson's disease, coordination movement disorder, cerebellar diseases, psychosis, paresis, aphasia, and any other neurologic disorder that the Investigator feels would put the patient at undue risk or confound study results.
- •Evidence of hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), Epstein-Barr virus (EBV), or cytomegalovirus (CMV) infection.
- •Primary immunodeficiency or history of recurrent infections.
- •History of splenectomy.
- •Live or attenuated vaccine within 28 days prior to the Screening Visit or during the Screening Period.
- •Active, clinically significant bacterial, viral, fungal, mycobacterial, parasitic, or other infection, including severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection, within 14 days prior to Day
- •Active or latent tuberculosis (TB)
排除标准
- 未提供
研究组 & 干预措施
Part A Dose Escalation
Experimental
Patients with Sjogren's Disease treated with CLN-978 in dose escalation cohorts
干预措施: CLN-978 (Drug)
Part B Further Dose Evaluation
Experimental
Further evaluation of CLN-978 treatment of patients with Sjogren's Disease
干预措施: CLN-978 (Drug)
结局指标
主要结局
Safety and Tolerability
时间窗: 48 weeks
Incidence and severity of adverse events (AEs), serious AEs (SAEs), AEs of special interest (AESIs).
次要结局
- To evaluate the PK of CLN-978(48 weeks)
- Detection of anti-drug antibodies(48 weeks)
- Change from baseline in B lymphocyte cell numbers in peripheral blood(48 weeks)
- Detection of anti-drug antibodies(48 weeks)
研究者
研究点 (25)
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