CTRI/2025/12/099352尚未招募2 期
A Study Evaluating Monthly (Every 4 Weeks) Dosing of Atacicept in Patients with IgAN
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 90
- 试验地点
- 11
- 主要终点
- Evaluate the effect of atacicept on Gd-IgA1 in patients with
研究概览
简要总结
Atacicept is currently in Phase 3 clinical development for the treatment of IgAN and is administered 150 mg once-weekly via prefilled syringe (PFS). Because of the health-relatedquality of life and economic benefits, ongoing efforts aim to improve convenience with afocus on the frequency and ease of administration. Exploring a longer dosing interval (ie,once-monthly injection) is supported by the long half-life of atacicept.The primary objective of this Phase 2 study is to explore the dose-response relationship ofonce-monthly atacicept PFS across different dose levels (300 mg, 450 mg, and 600 mg)versus 150 mg once-weekly atacicept PFS in patients with IgAN. The safety, tolerability, andefficacy/pharmacodynamics of atacicept compared with once-weekly atacicept will also be investigated.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •1 Must have the ability to understand and sign a written informed consent form which must be obtained prior to initiation of study assessments 2 Adult male or female of greater than or equal to 18 years of age or as per country specific legally or nationally recognized adult age who provides written informed consent prior to performing any study assessments 3 Diagnosis of IgAN as demonstrated by renal biopsy conducted within 10 years of the screening visit 4 Total urine protein excretion greater than or equal to zero point 75 g per 24 hour or urine protein to creatinine ratio UPCR greater than or equal to zero point 75 mg per mg based on a 24 hour urine sample during the screening period 5 eGFR greater than or equal to 30 mL per min per 1 point 73 m2 at screening as per the Chronic Kidney Disease Epidemiology Collaboration CKD EPI equation 6 On a stable prescribed regimen of RASi ACEi or ARB for at least 8 weeks that is at the maximum labeled or tolerated dose at screening and from screening to study Day 1 The participant is eligible if they do not tolerate RASi provided their management of IgAN is standard of care per local practice This intolerance must be documented by the investigator and discussed with the Medical Monitor SGLT2i MRA ERA and or GLP 1RA are permitted provided the dosing regimens is stable for at least 8 weeks prior to screening 7 Systolic blood pressure less than or equal to 160 mmHg and diastolic blood pressure less than or equal to 90 mmHg at screening 8 A female is eligible if she is not pregnant that is 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 as defined in Appendix 1 OR Is a WOCBP who agrees to use a highly effective contraceptive method that is has a failure rate of less than 1 percent per year as listed in Appendix 1 at least 7 days prior to randomization through 175 days after the last dose of study drug.
排除标准
- •1 Participation in a study of atacicept or any previous treatment with atacicept 2 IgAN secondary to another condition eg liver cirrhosis or other causes of mesangial IgA deposition including IgA vasculitis example Henoch-Schonlein purpura systemic lupus erythematosus dermatitis herpetiformis ankylosing spondylitis 3 Evidence of rapidly progressive glomerulonephritis loss of greater than or equal to 50 Percentage of eGFR within 3 months of screen 4 Total urine protein excretion greater than or equal to 5g per 24 hours or UPCR greater than or equal to 5 mg per mg based on a 24 hour urine sample during the screening perioding 5 Evidence of nephrotic syndrome within 6 months of screening serum albumin less than 3point0 g per dL in association with UPCR greater than 3point5 mg per mg 6 Renal or other organ transplantation prior to or expected during the study, with the exception of corneal transplants 7 Concomitant chronic renal disease in addition to IgAN example diabetic nephropathy primary focal segmental glomerulosclerosis membranous nephropathy C3 glomerulopathy, lupus nephritis 8 Uncontrolled diabetes defined as hemoglobin A1c HbA1c greater than 7point5 percentage at screening 9 History of tuberculosis TB, untreated latent TB infection LTBI or evidence of active TB determined by a positive Quantiferon test at the screening visit If the participant is undergoing current treatment for LTBI they must have received at least 4 continuous weeks of an appropriate LTBI treatment prior to the screening visit without evidence of reexposure 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 study 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 Indeterminate Quantiferon tests may be repeated once by the same test and will be considered positive if retest results are positive or indeterminate 10 Use of any of the following prohibited medications Systemic corticosteroids including oral budesonide for the treatment of IgAN within 6 months prior to screening from screening to Day 1 or expected use during the study For glucocorticosteroids 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 otic and intranasal For nonIgAN indications eg gout flare exacerbation of asthma severe rash etc as follows Within 12 weeks prior to randomization Use of systemic corticosteroids or immunosuppressive medications for greater than 1 week or average dose greater than 0point5 mg per kg per day prednisolone or equivalent Immunosuppressive medications example mycophenolate mofetil MMF, azathioprine cyclophosphamide hydroxychloroquine for the treatment of IgAN within 12 weeks prior to screening from screening to Day 1 or expected use during the study Use of traditional Chinese medications and or Ayurvedic medications for IgAN within 12 weeks prior to screening from screening to Day 1 or during the study period Including but not limited to Lei Gong Teng Tripterygium Wilfordii Hook F Caulis sinomenii and Sinomenium acutum Any other medications used to treat IgAN that are not listed should be discussed with the Medical Monitor Use of B cell directed biologic therapies including but not limited to belimumab rituximab, or ocrelizumab for any period of time Use of other biologics example anti TNF abatacept, anti IL 6 and investigational biologics for any period of time 11 Clinically significant or predefined abnormalities per central laboratory tests at the screening visit meeting any of the following criteria Serum IgG below 7 g per L AST ALT or ALP level greater than 2point5 × upper limit of normal ULN or total bilirubin greater than 1point5 × 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 12 Administration of live and live attenuated vaccinations within 30 days prior to randomization 13 History or current diagnosis of any demyelinating disease such as but not restricted to multiple sclerosis or optic neuritis 14 Patients with history of unstable angina, Class III and IV congestive heart failure and or clinically significant arrhythmia as judged by the investigator 15 Any condition, including any uncontrolled disease state other than IgAN, that in theopinion of the investigator or the sponsor or designee constitutes an inappropriate risk or a contraindication for participation in the study or that could interfere with the study objectives conduct or evaluation.
- •16 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 or during the screening visit or completion of oral anti infectives within 2 weeks prior to or during the screening visit or a history of recurrent infections example 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 17 History of acute or chronic infection with human immunodeficiency virus HIV or hepatitis B virus HBV Positive hepatitis B surface antigen HBsAg is excluded Participants who are HBsAg negative hepatitis B core antibody HBcAb positive hepatitis B surface antibody HBsAb positive and with no detectable HBV DNA are eligible but will require monthly HBV DNA monitoring through safety follow up 18 Participants with positive hepatitis C virus 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 19 History of splenectomy 20 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 evidence of recurrence 21 Known hypersensitivity to atacicept or any component of the formulated atacicept 22 Major surgery within 6 weeks prior to the screening visit or planned or 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 chest or skull Types of surgery that have the highest risk include heart lung liver and abdomen surgeries or major operations on the bones and joints eg hip replacement 23 Clinically significant history of alcohol or drug abuse in the 1 year prior to the screening visit as per investigators opinion 24 Unwillingness or lack of capacity to follow all study procedures 25 Treatment with other investigational agents within the last 4 weeks or 5 half lives whichever is longer prior to the screening visit.
结局指标
主要结局
Evaluate the effect of atacicept on Gd-IgA1 in patients with
时间窗: Week 24
IgAN
时间窗: Week 24
次要结局
- Evaluate the effect of atacicept on serum immunoglobulins((IgA, IgG, IgM))
- Evaluate serum PK of atacicept(End of the study)
- Evaluate the immunogenicity of atacicept(End of the study)
- Evaluate the effect of atacicept on change in proteinuria(End of the study)
- Evaluate the safety and tolerability of atacicept at different dosing regimens
研究者
Seth Schulman
Worldwide Clinical Trials
研究点 (11)
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