NCT05248659Enrolling By Invitation2 期
A Phase 2/3, Multicenter, Open-label Trial to Evaluate the Long-term Safety, Tolerability, and Efficacy of Sibeprenlimab Administered Subcutaneously in Subjects With Immunoglobulin A Nephropathy.
Otsuka Pharmaceutical Development & Commercialization, Inc.158 个研究点 分布在 9 个国家目标入组 600 人开始时间: 2022年4月5日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- Enrolling By Invitation
- 入组人数
- 600
- 试验地点
- 158
- 主要终点
- Adverse Events
研究概览
简要总结
To evaluate the long-term safety and tolerability of sibeprenlimab in subjects with IgAN
详细描述
This is a phase 2/3, multicenter, open-label trial to evaluate the long-term safety, tolerability, and efficacy of sibeprenlimab administered subcutaneously (SC) to subjects with IgAN.
Eligible subjects will have participated in trials 417-201-00007 or VIS649-201 and, in the investigator's judgement, could benefit from continued treatment with sibeprenlimab.
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subjects who completed Trial 417-201-00007 (at least 20 of the 26 doses over a 2-year duration and the end-of-trial visit) or Trial VIS649-201 (at least 9 of the 12 doses over a 1-year duration and the end-of-trial visit) without safety concerns and who, in the opinion of the investigator, could potentially benefit from treatment with sibeprenlimab for IgAN.
- •Ability to provide written, informed consent prior to initiation of any trial-specific procedures, and ability, in the opinion of the principal investigator, to comply with all the requirements of the trial.
排除标准
- •Subjects who have not completed participation in Trials 417-201-00007 or VIS649-
- •Subjects with treatment-limiting AEs during Trials 417-201-00007 or VIS649-201 considered related to IMP per investigator judgement.
- •Noncompliance, due to subject's repeated failure to follow trial procedures during the course of their participation in Trials 417-201-00007 and VIS649-201 (eg, subjects deemed to be noncompliant with the visit schedule, trial assessments, or treatment regimen). The medical monitor should be contacted if the investigator is unsure of a subject's eligibility.
- •Subjects who have a positive pregnancy test result prior to receiving IMP.
- •Heterosexually active biological males or subjects of childbearing potential, or their partners, who do not agree to adhere to contraceptive requirements from the time of consent through the end of the subject's participation in the trial and an additional 90 days (biological male subjects) or 30 days (biological female subjects) thereafter.
- •Biological male subjects who do not agree to avoid donation of sperm from the time of consent through the end of the subject's participation in the trial and an additional 90 days thereafter.
- •Subject has nephrotic syndrome, defined for this purpose as 24-hour urine protein > 3.5 g with concurrent hypoalbuminemia (serum albumin < 2.5 g/dL), hyperlipidemia (total cholesterol > 350 mg/dL), and edema. Subjects with isolated nephrotic range proteinuria (> 3.5 g/day) will be eligible.
- •Subject has a history or current evidence of a serious and/or unstable cardiovascular, respiratory, gastrointestinal, hematologic, autoimmune, rheumatologic, blood dyscrasias or other medical disorder, including psychiatric disorders, cirrhosis, or ongoing malignancy. History of minor skin cancers (not including melanoma) or surgically treated, limited cervical carcinomas (ie, carcinoma in situ) are not exclusionary.
- •History of a previous hypersensitivity or severe allergic reaction with generalized urticaria, angioedema or anaphylaxis to any of the ingredients of the sibeprenlimab SC injection formulation.
- •Subject has a body mass index < 16 kg/m^
- •Subject has received an organ transplant (ie, solid or a bone marrow or hematologic stem cell transplantation).
- •Subject is currently receiving, or has received within 16 weeks prior to enrollment, systemic immunosuppressive therapy (ie, steroids such as targeted release budesonide, complement inhibitors, mycophenolate, rituximab). Note: topical, ophthalmic, rectal, intra-articular, inhaled corticosteroids, and short courses of oral/intravenous steroids (<= 14 days) are allowed.
研究组 & 干预措施
Sibeprenlimab 400 mg s.c. q 4 weeks
Experimental
干预措施: Sibeprenlimab 400 mg s.c. Q4weeks (Drug)
结局指标
主要结局
Adverse Events
时间窗: From baseline to the end-of-trial visit in Week 112.
次要结局
- Time to Progression of Chronic Kidney Disease, as defined in the protocol(Over 24 months)
- Proportion of Subjects with Clinical Remission as defined in the protocol(At 12 and 24 months)
- Annualized slope of Estimated Glomerular Filtration Rate (eGFR)(Over 12 and 24 months)
- Urine protein/creatinine ratio (uPCR) in a 24-hour collection(At 12 and 24 months)
研究者
研究点 (158)
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