2024-519638-22-00招募中3 期
A multicenter open-label extension study to evaluate the long-term safety and tolerability of zigakibart in adults with primary IgA nephropathy
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 69
- 试验地点
- 44
- 主要终点
- Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)
研究概览
简要总结
The primary objective of this study is to evaluate the long-term safety and tolerability of zigakibart in eligible participants receiving open-label zigakibart.
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
- 否
入选标准
- •Signed informed consent must be obtained prior to participation in the OLE study.
- •Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol
- •Per Investigator’s clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.
排除标准
- •Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason
- •Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
- •History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.
- •Confirmed IgG levels < 3 g/L prior to first study treatment administration in the OLE study.
- •Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
- •Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.
- •Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥ 30 days) or who require kidney transplantation.
- •Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
- •Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.
- •Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.
- •Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for > 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.
- •Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.
- •Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction [PCR] will be allowed), or antibodies to HIV-1 and/or HIV-
- •Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are eligible for the study).
研究组 & 干预措施
Bion 1301/FUB523
Test
干预措施: Bion 1301/FUB523 (Drug)
结局指标
主要结局
Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)
Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)
Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI)
Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI)
次要结局
- Change from Baseline to Weeks 48 and 96 in UPCR based on 24h-urine collection
- Change from Baseline to Week 96 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation
- Change from BEYOND parent study Baseline to Week 96 of OLE study in eGFR
- Serum concentrations of zigakibart
- Changes from baseline in immunoglobulin levels
- Presence of circulating binding and neutralizing antidrug antibodies (ADA/Nab)
- Safety laboratory parameters and vital signs
研究者
Novartis Pharma Arzneimittel GmbH
Scientific
Novartis Pharma AG
研究点 (44)
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