2024-516380-81-00招募中2 期
A Multicenter, Rollover Study to Evaluate the Long-Term Safety and Efficacy of Atacicept
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 23
- 试验地点
- 12
- 主要终点
- Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events
研究概览
简要总结
To evaluate the long-term safety and tolerability of atacicept.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 是
入选标准
- •Must have the ability to understand and sign a written informed consent form, which must be obtained prior to initiation of study assessments.
- •Completed the protocol-defined treatment period on treatment in a parent study of atacicept in patients with IgAN.
- •For Atacicept Drug Holiday Group only: Systolic blood pressure ≤150 mmHg and diastolic blood pressure ≤90 mmHg at screening and Day
- •A participant who was assigned female at birth is eligible if not pregnant (ie, after a confirmed menstrual period, a negative serum pregnancy test at screening and has a negative urine pregnancy test at Day 1), is not breastfeeding (for at least three 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 (ie, has a failure rate of less than 1% per year) at least 7 days prior to enrollment, through 175 days after the last dose of study drug.
- •For Atacicept Drug Holiday Group only: eGFR ≥ 20 mL/min/1.73 m2 at screening, as per the Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation.
- •For Atacicept Drug Holiday Group only: On a stable prescribed regimen of renin-angiotensin-aldosterone system inhibitor (ACEi or ARB) per guidance and local standard of care that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1.
排除标准
- •For Group 1 Atacicept Drug Holiday: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of screening).
- •For Group 1 Atacicept Drug Holiday: History of acute or chronic infection with human immunodeficiency virus, hepatitis C virus, or hepatitis B virus. • Participants who are positive hepatitis B surface antigen (HBsAg) are excluded • Participants who are HBsAg negative, hepatitis B core antibody (HBcAb) positive, hepatitis B surface antibody (HBsAb) positive with no detectable hepatitis B virus (HBV) DNA are eligible but will require monthly HBV DNA monitoring through safety follow up. • Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
- •For Group 1 Atacicept Drug Holiday: History of splenectomy.
- •For Group 1 Atacicept Drug Holiday: History of malignancy (hematologic or solid tumor) within 5 years prior to Day 1, 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 Group 1 Atacicept Drug Holiday: Known hypersensitivity to atacicept or any component of the formulated atacicept
- •For Group 1 Atacicept Drug Holiday: Major surgery within 6 weeks prior to screening or planned/expected major surgery during the study period (including the safety follow-up period) - Major surgery often involves opening one of the major body cavities (abdomen or chest) and/or use of general anesthesia. Types of surgery that have the highest risk include heart or lung, liver, abdomen, or major operations on the bones and joints (eg, hip replacement). Participants with positive hepatitis C (HCV) RNA are excluded, however participants who are HCV antibody positive with no detectable HCV RNA at least 24 weeks after completion of antiviral therapy are eligible.
- •For Group 1 Atacicept Drug Holiday: Clinically significant history of alcohol or drug abuse in the 1 year prior to Day 1 as per Investigator opinion
- •For Group 1 Atacicept Drug Holiday: Unwillingness or lack of capacity to follow all study procedures
- •For Group 1 Atacicept Drug Holiday: Treatment with other investigational agents within the last 4 weeks or 5 half-lives, whichever is longer, prior to screening
- •For Group 1 Atacicept Drug Holiday: Total urine protein excretion ≥5g per 24-hour or UPCR ≥5 mg/mg based on a 24-hour urine sample during the Screening Period
- •For Group 1 Atacicept Drug Holiday: Uncontrolled diabetes, defined as hemoglobin-A1c (HbA1c) >7.5% at screening
- •For Group 1 Atacicept Drug Holiday: Evidence of nephrotic syndrome (serum albumin <30g/L in association with UPCR >3.5 mg/mg) within 6 months of screening.
- •For Group 2 Continuous Atacicept: Evidence of rapidly progressive glomerulonephritis (loss of ≥50% of eGFR within 3 months of Day 1)
- •For Group 2 Continuous Atacicept: Evidence of nephrotic syndrome (serum albumin <30g/L in association with UPCR >3.5 mg/mg) within 6 months of Day 1
- •For Group 2 Continuous Atacicept: Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of Day 1
- •For Group 2 Continuous Atacicept: Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants
- •For Group 2 Continuous Atacicept: Clinically significant or predefined abnormalities per central laboratory tests on Day 1 , meeting any of the criteria below: • Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator
- •For Group 2 Continuous Atacicept: Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to enrollment, or completion of oral anti-infectives within 2 weeks prior to enrollment, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary.
- •For Group 2 Continuous Atacicept: Known hypersensitivity to atacicept or any component of the formulated atacicept
- •For Group 2 Continuous Atacicept: Clinically significant history of alcohol or drug abuse in the one year prior to Day 1 as per Investigator opinion
- •For Group 2 Continuous Atacicept: Unwillingness or lack of capacity to follow all study procedures
- •For Group 1 Atacicept Drug Holiday: Currently on chronic dialysis, or expected to initiate dialysis within 12 weeks of screening.
- •For Group 1 Atacicept Drug Holiday: Renal or other organ transplantation prior to, or expected during, the study, with the exception of corneal transplants.
- •For Group 1 Atacicept Drug Holiday: Prohibited medications: • Use of systemic corticosteroids (including oral budesonide) or immunosuppressive medications (eg, MMF, azathioprine, cyclophosphamide, hydroxychloroquine) for the treatment of IgAN within 2 months prior to Screening • For glucocorticosteroids (GCS), “Systemic” is defined as oral, rectal or injectable (intravenous or intramuscular) routes of administration. Other routes of administration are allowed, including intra-articular, inhaled, topical, ophthalmic, optic and intranasal. • Use of B-cell–directed biologic therapies including belimumab, rituximab, ocrelizumab within 12 months of screening • Use of other biologics (eg, anti-TNF, abatacept, anti-IL-6) and investigational biologics for the treatment of IgAN within 6 months of screening
- •For Group 1 Atacicept Drug Holiday: Clinically significant or predefined abnormalities per central laboratory tests at screening, meeting any of the criteria below: - Clinical evidence of immunosuppression and/or hypogammaglobulinemia as determined by the Investigator. - Aspartate aminotransferase, alanine aminotransferase or alkaline phosphatase level >2.5 × upper limit of normal (ULN) or total bilirubin >1.5 x ULN. *If the participant 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 Group 1 Atacicept Drug Holiday: Administration of live and live-attenuated vaccinations within 30 days prior to enrollment
- •For Group 1 Atacicept Drug Holiday: History or current diagnosis of any demyelinating disease such as, but not restricted to, multiple sclerosis (MS) or optic neuritis (ON)
- •For Group 1 Atacicept Drug Holiday: Active clinically significant viral, bacterial or fungal infection, or any major episode of infection requiring hospitalization or treatment with parenteral anti-infectives within 4 weeks prior to enrollment, or completion of oral anti-infectives within 2 weeks prior to enrollment, or a history of recurrent infections (ie, 3 or more of the same type of infection in a 12-month rolling period). Vaginal candidiasis, onychomycosis and genital or oral herpes simplex virus considered by the Investigator to be sufficiently controlled are not exclusionary. • If the participant is undergoing current treatment for latent tuberculosis infection (LTBI), they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to screening without evidence of re-exposure to be eligible for this study. If on LTBI treatment at the Screening visit, the participant will be expected to complete an appropriate LTBI treatment regimen to remain in the trial. • Participants with current household contacts with active TB will be excluded unless prophylaxis treatment has been completed, and evidence that household contacts have completed treatment is provided. • Evidence of active TB determined by a local laboratory at the Screening Visit. Indeterminate local TB tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate.
结局指标
主要结局
Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events
Long-term safety and tolerability of atacicept as assessed by routine clinical and laboratory tests and adverse events
次要结局
- The effect of atacicept on the following: *Changes in proteinuria based on UPCR and UACR as determined by spot urine. *Changes in estimated glomerular filtration rate (eGFR) based on serum creatinine and cystatin C, respectively. *Hematuria level based on blood on urine dipstick. *Changes in serum Gd-IgA1 levels.
研究者
Regulatory
Scientific
Vera Therapeutics Inc.
研究点 (12)
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