CTIS2023-503772-24-00招募中1 期
A Phase 2b/3, Multi-part, Randomized, Double-Blinded, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Atacicept in Subjects with IgA Nephropathy (IgAN) - VT-001-0050
适应症
试验速览
- 阶段
- 1 期
- 状态
- 招募中
- 入组人数
- 338
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
- 年龄范围
- 18 至 65+（—）
- 性别
- All
入选标准
- •Phase 2b_01. Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments, Phase 3_02. Adult male or female of =18 years of age, or as per country specific legally or nationally recognized adult age, who provide written informed consent prior to performing any study assessments, Phase 3_03. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the Screening Visit, Phase 3_04. Total urine protein excretion =1.0 g per 24-hour or urine protein to creatinine ratio (UPCR) =1.0 mg/mg based on a 24-hour urine sample during the Screening Period, Phase 3_05. eGFR = 30 mL/min/1.73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, Phase 3_06. On a stable prescribed regimen of RASi (ACEi or ARB) for at least 12 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 • The subject is eligible if they do not tolerate RASi, provided their management of IgAN is standard of care (SoC) per local practice. This intolerance must be documented by the Investigator and discussed with the Medical Monitor., Phase 3_07. Systolic blood pressure =150 mmHg and diastolic blood pressure =90 mmHg at screening, Phase 3_08. A female is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1), not breastfeeding (for at least 3 months prior to screening), and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP). OR • Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appendix 2, at least 7 days prior to randomization through 175 days after the last dose of study drug. See Appendix 2 for further details., Phase 2b_02. Adult male or female of =18 years of age, or as per country specific legally or nationally recognized adult age, who provide written informed consent prior to performing any study assessments. For the Czech Republic an age limit of =70 also applies, Phase 2b_03. Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the Screening Visit, Phase 2b_04. Total urine protein excretion > 0.75g per 24-hour or UPCR > 0.75 mg/mg based on a 24-hour urine sample during the Screening Period, Phase 2b_05. eGFR = 30 mL/min/1.73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation, Phase 2b_06. On a stable prescribed regimen of RAASi for at least 12 weeks that is at the maximum labeled or tolerated dose at screening. • The subject is eligible if they do not tolerate RAASi, provided their management of IgAN is SoC according to local guidelines. This must be documented by the Investigator., Phase 2b_07. Systolic blood pressure =150 mmHg and diastolic blood pressure =90 mmHg at screening, Phase 2b_08. A female is eligible if she is not pregnant (i.e., after a confirmed menstrual period, a negative serum pregnancy test at screening and negative urine pregnancy test at Day 1), not breastfeeding (for at least 3 months prior to screening), and at least one of the following conditions applies: • Is not a woman of childbearing potential (WOCBP). OR • Is a WOCBP who agrees to use a highly effective contraceptive method (i.e., has a failure rate of less than 1% per year), as listed in Appen
排除标准
- •Phase 2b_01. IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), SLE, dermatitis herpetiformis, ankylosing spondylitis, Phase 2b_04. Total urine protein excretion = 5g per 24-hour or urine protein to creatinine ratio (UPCR) = 5 mg/mg based on a 24-hour urine sample during Screening, Phase 2b_05. Renal or other organ transplantation prior to, or expected during, the study with the exception of corneal transplants, Phase 2b_10. Clinically significant or predefined abnormalities per central laboratory tests, at the Screening Visit, meeting any of the criteria below: • serum IgG below 7 g/L • aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level > 2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. i. If subject has a known history of Gilberts (history of isolated increase in total bilirubin without increase in liver transaminases), contact the Medical Monitor for further discussion. • For The Czech Republic only, the following criteria also apply: - hemoglobin <10 g/100 mL in men and hemoglobin <9 g/100 mL in women - platelets <100,000/mm3, Phase 2b_06. Concomitant chronic renal disease in addition to IgAN (e.g., diabetic nephropathy, primary focal segmental glomerulosclerosis (FSGS), membranous nephropathy, C3 glomerulopathy, lupus nephritis), Phase 2b_07. Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening, Phase 2b_08. History of tuberculosis (TB), untreated latent TB infection (LTBI), or evidence of active TB determined by a positive Quantiferon test at the Screening Visit., Phase 2b_09. Prohibited medications: • Use of systemic corticosteroids or immunosuppressive medications (e.g., MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 3 months prior to screening or expected use during the study. • For non-IgAN indications (e.g., gout flare, exacerbation of asthma, severe rash, etc): • Within 3 months prior to randomization: Use of systemic corticosteroids or immunosuppressive medications for > 1 week or 0.5 mg/kg/day prednisolone or equivalent • Use of B-cell–directed biologic therapies including blisibimod, belimumab, rituximab, ocrelizumab for any period of time • Use of other biologics (e.g., anti-TNF, abatacept, anti-IL-6) and investigational biologics, Phase 3_01. Participation in the Phase 2b (Parts A and B) study or any previous treatment with atacicept., Phase 3_02. IgAN secondary to another condition (e.g., liver cirrhosis), or other causes of mesangial IgA deposition including IgA vasculitis (i.e., Henoch-Schonlein purpura), systemic lupus erythematosus (SLE), dermatitis herpetiformis, ankylosing spondylitis, Phase 3_03. Evidence of rapidly progressive glomerulonephritis (loss of = 50% of eGFR within 3 months of screening), Phase 2b_18. History of malignancy (hematologic or solid tumor) within 5 years prior to Screening Visit, except adequately treated basal cell or squamous cell carcinomas of the skin (no more than 3 lesions requiring treatment in lifetime) or carcinoma in situ/cervical intraepithelial neoplasia of the uterine cervix. *For Germany only the following criteria apply: History of malignancy within the past 5 years prior to Screening (except for adequately treated basal cell carcinoma or non-metastatic squamous cell carcinoma of the skin or cervical carcinoma in situ, with no
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