NCT02725476已完成2 期
An Open-label, Single-arm, Pilot Study to Evaluate the Effect of XmAb®5871 on Disease Activity in Patients With IgG4-Related Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Xencor, Inc.
- 入组人数
- 20
- 试验地点
- 2
- 主要终点
- Proportion of Patients With an Improvement in IgG4-RD Activity
研究概览
简要总结
The purpose of this Phase 2 study is to investigate the effect of XmAb5871 on IgG4-Related Disease (RD) activity
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Active IgG4-RD
- •Compatible pattern of organ involvement consistent with IgG4-RD that cannot be attributed to other causes
- •Histopathologically-proven diagnosis of IgG4-RD
- •Peripheral blood plasmablast count >900 cells/mL and/or elevated IgG4-RD levels during screening
- •Able and willing to complete the entire study according to the study schedule
- •Able and willing to provide written informed consent
排除标准
- •History or evidence of a clinically unstable/uncontrolled disorder, condition or disease other than IgG4-RD that, in the opinion of the Investigator would pose a risk to the patient safety or interfere with the study evaluation, procedures or completion
- •Malignancy within 5 years (except successfully treated in situ cervical cancer, resected squamous cell or basal cell carcinoma of the skin, or prostate cancer with no recurrence ≥3 years following prostatectomy)
- •Presence of recurrent or chronic infections, defined as ≥3 infections requiring antimicrobials over the past 6 months prior to screening
- •Active infection requiring hospitalization or treatment with parenteral antimicrobials within the 60 days prior to randomization or oral antimicrobials within the 21 days prior to enrollment
- •Patient is taking >40 mg of prednisone QD
- •Prior use of rituximab (or other B cell depleting agents) within 6 months of enrollment. Prior use of any B cell depleting agent greater than 6 months from enrollment is allowed if the CD19+ B cell count is within the normal reference range during screening
- •Use of any investigational agent within 5 half-lives of the agent (or 6 months if the half-life is unknown) prior to enrollment
- •Immunosuppressive agent use within the three months prior to enrollment
- •Has received live vaccines within 2 months of enrollment
- •Patient is pregnant or breast feeding, or planning to become pregnant while enrolled in the study, up to end-of-study visit
- •Unable or unwilling to partake in the follow-up assessments or required protocol procedures
研究组 & 干预措施
XmAb5871
Experimental
XmAb5871 administered by IV infusion for up to a total of 12 infusions
干预措施: XmAb5871 (Biological)
结局指标
主要结局
Proportion of Patients With an Improvement in IgG4-RD Activity
时间窗: Baseline Day 1 to Day 169
Improvement of disease activity as defined by a decrease of IgG4-RD responder index \>= 2 points from Day 1 pre-dose disease activity score. The IgG4-RD Responder Index Total Activity Score ranges from 0 to a maximum of 162. Higher scores represent greater (i.e. worse) disease activity. A score of 0 represents no disease activity other than residual fibrosis.
次要结局
- Number of Patients Experiencing a Treatment-emergent Adverse Event as Assessed by CTCAE v4.3(Baseline Day 1 to Day 197)
研究者
研究点 (2)
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