2024-519345-30-00招募中3 期
A Phase 3, Randomized, Double-blind, Placebo-controlled Study of Felzartamab in Adults with IgA Nephropathy (299IG301 / PREVAIL)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 201
- 试验地点
- 82
- 主要终点
- Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
研究概览
简要总结
The primary objective of the study is to evaluate the efficacy of felzartamab compared to placebo on proteinuria in participants with Immunoglobulin A nephropathy (IgAN)
研究设计
- 分配方式
- Randomized
- 主要目的
- A Ph3, Randomized,double-blind,placebo-controlled Study Of Felzartamab In Adults With Ig An (prevail)
- 盲法
- Double (Carer, Analyst, Subject, Monitor, Investigator)
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Biopsy-confirmed diagnosis of IgAN within the past 10 years prior to signature of the informed consent form (ICF). For participants with diabetes mellitus type 2, biopsy confirmation of IgAN diagnosis must be done within the past 24 months prior to signing the ICF.
- •An eGFR ≥ 30 mL/min/1.73m^2 at Screening as calculated using the 2021 chronic kidney disease epidemiology (CKD-EPI) creatinine formula. An eGFR of ≥ 20 and < 30 mL/min/1.73m^2 is acceptable for the cohorts 3 and
- •Clinically stable on a maximally tolerated dose or maximally approved dose of angiotensin-converting enzyme inhibitors (ACEI) or angiotensin receptor blockers (ARB) for at least 12 weeks prior to Screening, or intolerant of ACEI or ARB. If intolerant, this must be discussed with the Medical Monitor prior to randomization. Participants may also be using sodium-glucose cotransporter-2 inhibitors (SGLT2is), endothelin receptor antagonists (ERAs) approved for the treatment of IgAN, dual endothelin angiotensin receptor antagonists (DEARAs) approved for the treatment of IgAN, and/or mineralocorticoid receptor antagonists (MRAs) as long as the dose is stable for at least 12 weeks prior to Screening. Participants should remain on stable doses of these background medications for the duration of the study. Once the ICF is signed and thereafter, the doses cannot be changed during the study nor the drugs discontinued except if deemed related to an AE. Participants using sparsentan will not be permitted to use simultaneous ACEI or ARB medication.
- •Proteinuria of ≥ 1.0 gram per day (g/day) or UPCR ≥0.8 gram per gram (g/g) as assessed by an adequate 24-hour urine collection.
排除标准
- •Secondary forms of IgAN, indicated by the presence of any other systemic disease potentially leading to IgA deposits as determined by the Investigator.
- •Previously treated with immunosuppressive or other immunomodulatory agents such as but not limited to cyclophosphamide, rituximab, infliximab, eculizumab, canakinumab, MMF or mycophenolate sodium (MPS), cyclosporine, tacrolimus, sirolimus, everolimus, or systemic corticosteroids exposure (> 7.5 mg/d prednisone/prednisolone equivalent) within 4 months (or 12 months for rituximab) prior to Screening.
- •Note: Other protocol defined Inlcusion/Exclusion criteria may apply
- •Participants currently treated with oral budesonide. Patients who have stopped this therapy ≥ 4 months prior to Screening may be eligible.
- •Active clinically significant infections, known history of recurrent clinically significant infection, or Screening laboratory evidence consistent with an active infection, or IV anti- infectives (antibacterials, antivirals, or antifungals). Participants with a history of opportunistic infections are excluded.
- •History of rapidly progressive variant of IgAN, defined as eGFR loss by > 50% per 3 months and not explained by changes in RAS blockade or other factors.
- •Nephrotic syndrome presumed to be due to minimal change disease (MCD) variant
- •Concomitant other progressive glomerulonephritis or non-immunologic glomerular disease such as diabetic nephropathy.
- •Type 2 diabetes mellitus with hemoglobin A1c (HbA1c) > 8% at Screening, or evidence of diabetic nephropathy on biopsy, history of diabetic microvascular or macrovascular disease (eg, diabetic retinopathy, peripheral neuropathy).
- •Any diagnosed or suspected immunosuppressed or immunodeficient state such as asplenia, Human Immunodeficiency virus (HIV), primary immunodeficiencies, organ or bone marrow transplantation, with the exception of corneal transplants.
- •Hypogammaglobulinemia: Serum Immunoglobin G (IgG) < 6.0 gram per litre (g/L), at Screening
结局指标
主要结局
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
Percent Change From Baseline in Proteinuria as Measured by the Urine Protein: Creatinine Ratio (UPCR)
次要结局
- Change From Baseline in Estimated Glomerular Filtration Rate (eGFR) Values Calculated Using the Chronic Kidney Disease Epidemiology (CKD-EPI) Creatinine Equation
- Percentage of participants who progressed to Kidney Malfunction. The percentage of participants progressing to kidney malfunction will be reported based on one of the following, 1. ≥ 40% reduction in eGFR sustained for ≥ 30 days; 2. eGFR < 15 mL/min/1.73m2 for ≥ 30 days; 3. Undergoing dialysis for ≥ 30 days; 4. Undergoing kidney transplantation; 5. Died from kidney failure
- Percentage of participants requiring rescue therapy
- Felzartamab serum concentrations over time
- Number of patients with anti-drug antibodies (ADAs) against felzartamab
- Percentage of Participants With Treatment Emergent Adverse Event (TEAE) and Treatment Emergent Serious Adverse Event (TESAE)
- Number of Participants With Clinically Significant Change From Baseline in Vital Signs Abnormalities
- Number of Participants With Clinically Significant Change From Baseline in Physical Examination Abnormalities
- Percentage of participants Achieving complete response (CR) CR is defined as UPCR value (based on 24-hour urine collection) of <0.5 gram per gram (g/g), a reduction in UPCR of ≥50%, and a stable eGFR (decrease from baseline in eGFR of ≤25%)
- Change in Baseline in EGFR Values Calculated Using the CKD-EPI Creatinine Equation
- Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities
- Number of Participants With Clinically Significant Change From Baseline in Electrocardiogram (ECG) Abnormalities
研究者
Clinical Trials Information Desk
Scientific
Biogen Idec Research Limited
研究点 (82)
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