ISRCTN18188034进行中（未招募）3 期
A Phase III, multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of obexelimab in patients with IgG4-related disease (INDIGO)
适应症
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Males and females =18 years of age
- •2. Clinical diagnosis of IgG4-RD
- •3. Patients must meet the 2019 ACR/EULAR Classification Criteria for IgG4-RD
- •4. Patients must have active IgG4-RD signs/symptoms (i.e., flare) that require the initiation of GC therapy or the increase in background long-term GC therapy
- •5. Other inclusion criteria apply
排除标准
- •1. Has disease in only one organ system whose primary manifestation is fibrosis
- •2. Has received prednisone equivalent given orally at a dose greater than 60 mg/day within the 4 weeks prior to screening or during screening
- •3. Has received a non-biologic, disease-modifying anti-rheumatological drug or immunosuppressive agent other than GCs within the 4 weeks prior to screening
- •4. Has received an investigational treatment or direct medical intervention on another clinical study within 12 weeks or < 5 half-lives of the investigational treatment, whichever is shorter, prior to screening
- •5. Has received live vaccine or live therapeutic infectious agent within the 2 weeks prior to screening
- •6. Active tuberculosis or high risk for tuberculosis; hepatitis C infection in absence of curative treatment; evidence of hepatitis B infection
- •7. Use of B cell depleting or targeting agents within 6 months of randomization
- •8. Other exclusion criteria apply
研究者
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