2025-521752-26-00招募中2 期
A Phase 2 Study to Assess ADX-038 in Participants With Complement-Mediated Kidney Disease
Adarx Pharmaceuticals Inc.7 个研究点 分布在 2 个国家目标入组 7 人开始时间: 2026年1月15日最近更新:
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 7
- 试验地点
- 7
- 主要终点
- Incidence and severity of TEAEs
研究概览
简要总结
To evaluate the safety and tolerability of ADX-038
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
- 否
入选标准
- •Age ≥18 years at the time of signing informed consent.
- •Has clinical evidence of active kidney disease based on mean UPCR ≥0.8 g/g from two 24 hour urine collections within the Screening Period closest to Day 1 attributed to the kidney disease of the cohort in which they are enrolling, per the Investigator’s opinion.
- •Has been on supportive care including a stable dosing regimen of ACEi or ARB at the maximally tolerated dose (per Investigator’s judgment and local practice and not exceeding the locally approved maximal daily dose) for at least 30 days before Day 1 and the dosing regimen is expected to remain stable for the duration of the study. Participants with allergies or intolerance to ACEi/ARB are eligible, but the Investigator must document the reason for not taking these medications.
- •If taking diuretics, other antihypertensive therapy dose should be stable for 30 days. If taking renoprotective medications (including mineralocorticoid antagonists, SGLT2 inhibitors, GLP-1, sparsentan), the doses should be stable for at least 90 days prior to Day 1 and the dosing regimen is expected to remain stable for the duration of the study.
- •The following vaccine requirements need to be completed at least 2 weeks prior to Day 1: a. Completed vaccination schedule for Streptococcus pneumoniae, Haemophilus influenzae, and Neisseria meningitidis serotypes ACWY with appropriate boosters per local guidance. b. Completed at least 2 doses of a 3-dose vaccine series for Neisseria meningitidis serotype B (MenB). The third dose may be administered during the study.
- •Participants agree to receive vaccine boosters for MenACWY, MenB, Streptococcus pneumoniae, and Haemophilus influenzae as appropriate per local guidance during the study.
- •Women of childbearing potential must have 2 negative serum pregnancy tests during Screening and a negative urine pregnancy test on Day 1 before study drug administration and must agree to use highly effective contraceptive methods if engaged in sexual activity of childbearing potential (refer to Section 13.2) from the time of signing the informed consent form (ICF) until the EOS Visit or 28 days after the last dose of study drug, whichever is longer.
- •Participants must have been offered, or unable to take (due to reasons such as intolerance, availability, or patient/physician preference), any approved medications for the disease under study.
- •Women must not be breastfeeding.
- •Fertile men must agree to use acceptable contraceptive methods if engaged in sexual activity with a partner of childbearing potential (refer to Section 13.2) from the time of signing the ICF until the EOS Visit or 28 days after the last dose of study drug, whichever is longer.
- •Fertile men must agree not to donate sperm after study drug administration on Day 1 until the EOS Visit or 28 days after the last dose of study drug, whichever is longer.
- •Participants with IgAN (Cohort 1 and Cohort 3): Has a diagnosis of primary IgAN as confirmed by a kidney biopsy performed within 60 months prior to Screening or during Screening. The biopsy report must be reviewed and the diagnosis confirmed by the Investigator and must also show less than 50% global fibrosis and less than 50% glomeruli with cellular crescents.
- •Participants with C3G or IC-MPGN (Cohort 2): Has a diagnosis of C3G (including DDD) or IC-MPGN as confirmed by a kidney biopsy performed within 18 months prior to Screening or during Screening. The biopsy report must be reviewed and the diagnosis confirmed by the Investigator and must also show less than 50% global fibrosis and less than 50% glomeruli with cellular crescents.
- •Participants with C3G or IC-MPGN (Cohort 2): Participants on systemic corticosteroids or mycophenolic acid derivatives (ie, MMF or MPA), must be on a stable dose for at least 3 months prior to Screening and is expected to remain stable for the duration of the study. The systemic corticosteroid dose must be ≤15 mg/day prednisone or equivalent.
- •Has provided written informed consent and any authorizations required by local law and be willing to comply with all study requirements for the duration of the study.
- •Has a mean eGFR ≥30 mL/min/1.73m2 (using the creatinine-based the Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula 2021 for adults) from both Screening Visits (Inker 2021).
排除标准
- •Has a known or suspected hereditary or acquired complement deficiency.
- •Has evidence of monoclonal gammopathy of unclear significance (MGUS), infections, malignancy, autoimmune diseases, or other conditions to which C3G, IC-MPGN, or IgAN is secondary. This includes a diagnosis of Henoch-Schonlein Purpura (IgA vasculitis).
- •For IgAN, has taken chronic systemic corticosteroids at any dose (including budesonide) within 3 months prior to Screening, with the exception of corticosteroids used for <7 days for an acute reason >2 weeks prior to Day
- •For C3G or IC MPGN, has taken systemic corticosteroids >15 mg/day prednisone or equivalent for >7 days within 2 weeks prior to Day
- •Received complement inhibitor treatments (including eculizumab or ravulizumab) within 6 months prior to Day 1 or are considered to be nonresponders to complement inhibitor treatments.
- •Is currently using any systemic immunosuppressant biologics or broad immunosuppressants such as cyclophosphamide, JAK inhibitors, or CNI within 3 months prior to Day 1 with the exception of those permitted (eg, MMF for C3GN or IC MPGN). Use of longer acting biologics such as rituximab or obinutuzumab within 6 months prior to Day 1 is also exclusionary.
- •Has a history of active tuberculosis (TB [treated or untreated]), untreated latent TB infection (LTBI), or evidence of active TB during Screening (preferred testing is by Quantiferon when available and per local regulations). Note: Participants with history of treated latent TB are permitted to enroll if they have evidence of completion of treatment and they meet all other eligibility criteria.
- •Has an active systemic viral (including COVID-19), bacterial, or fungal infection within 14 days prior to Day
- •Has known HIV infection (per participant history and/or medical records) or a positive HIV test during Screening.
- •Has a positive serology test for hepatitis B surface antigen (HBsAg), has a prior diagnosis of untreated latent hepatitis B, or positive serology test for hepatitis C virus (HCV) with a detectable RNA concentration during Screening.
- •Has liver dysfunction as indicated by any of the following abnormal LFTs during Screening: a. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >1.5 × upper limit of normal (ULN). b. Total bilirubin >1.5 × ULN (unless due to Gilbert’s syndrome).
- •Has a systolic blood pressure >160 mmHg or a diastolic blood pressure >90 mmHg on Day
- •Optional retest may be performed as needed.
- •Received a kidney transplant or has received renal replacement therapy for >72 hours consecutively at any time.
- •Has any of the following laboratory parameters during Screening: a. White blood cell count >1.2 × ULN or <0.8 × lower limit of normal (LLN). b. Hemoglobin <9 mg/dL. c. Platelet count <100,000/μL.
- •Participated in an interventional drug study within the last 90 days or 5 half-lives, whichever is longer, prior to Screening.
- •Donated any blood products (>200 mL) within 30 days prior to Screening.
- •Received a blood transfusion within 90 days prior to Screening.
- •Received prior treatment with another CFB RNA/DNA-based therapy.
- •Has any other significant medical conditions that, in the opinion of the Investigator, would make the participant unsuitable for inclusion in the study, or could interfere with study assessments or put the participant at risk for experiencing significant adverse effects during the study.
- •Has a history of a major solid organ transplant (eg, heart, lung, liver) or has received a hematopoetic stem cell/bone marrow transplant.
- •Has other significant kidney diseases (outside of cohort in which they are enrolling) that would interfere with interpretation of the study.
- •Has presence of rapidly progressive glomerular nephritis or acute kidney injury.
- •Has a history of recurrent invasive infections caused by encapsulated bacteria (eg, meningococcus or pneumococcus).
- •Has a major concurrent comorbidity, including but not limited to advanced cardiac disease (eg, New York Heart Association class IV) or severe pulmonary disease (eg, severe pulmonary hypertension [World Health Organization class IV]). Any major cardiovascular event in the past year, including a myocardial infarction or a cerebrovascular event requiring hospitalization.
- •Has an active malignancy and/or a history of malignancy in the past 5 years, with the exception of completely excised non-melanoma skin cancer or low-grade cervical intraepithelial neoplasia and with no evidence of recurrence for ≥3 years prior to Day
- •Has a history of splenectomy.
研究组 & 干预措施
ADX-038
Test
干预措施: ADX-038 (Drug)
Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine, Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine, Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine, Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine
Auxiliary
干预措施: Nimenrix powder and solvent for solution for injection in pre-filled syringe Meningococcal groups A, C, W-135 and Y conjugate vaccine (Drug)
Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)., Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)., Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed)., Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed).
Auxiliary
干预措施: Infanrix hexa, Powder and suspension for suspension for injection. Diphtheria (D), tetanus (T), pertussis (acellular, component) (Pa), hepatitis B (rDNA) (HBV), poliomyelitis (inactivated) (IPV) and Haemophilus influenzae type b (Hib) conjugate vaccine (adsorbed). (Drug)
Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed), Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed)
Auxiliary
干预措施: Prevenar 20 suspension for injection in pre-filled syringe Pneumococcal polysaccharide conjugate vaccine (20-valent, adsorbed) (Drug)
Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed), Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed), Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed), Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed)
Auxiliary
干预措施: Bexsero suspension for injection in pre-filled syringe Meningococcal group B Vaccine (rDNA, component, adsorbed) (Drug)
结局指标
主要结局
Incidence and severity of TEAEs
Incidence and severity of TEAEs
次要结局
- 1. Change from baseline in UPCR as measured by 24-hour urine over time
- 2. Change from baseline in UPCR as measured by spot urine over time
研究者
Aditya Patel
Scientific
Adarx Pharmaceuticals Inc.
研究点 (7)
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