Study of NM8074 in Adult C3 Glomerulopathy Patients

Launched by NOVELMED THERAPEUTICS · Dec 3, 2022

Keywords

ClinConnect Summary

This clinical trial is studying a new medication called NM8074 to see how safe it is and how well it works for adults with a condition called C3 Glomerulopathy, which affects the kidneys. The study is in the early stages and will involve patients who are between 18 and 65 years old and have been diagnosed with C3 Glomerulopathy through a kidney biopsy in the past year. To participate, patients need to have specific low levels of a protein called C3 in their blood and must be willing to follow study procedures, including signing consent forms and attending scheduled visits.

Participants in this trial can expect to receive NM8074 through an intravenous (IV) infusion, meaning it will be given through a vein. Before starting the treatment, all participants will need to be vaccinated against certain infections. It’s important to note that some patients may not be eligible if they have other serious kidney diseases, are taking other experimental drugs, or have certain health conditions. This trial aims to gather important information about NM8074 and how it can help patients with this kidney disease.

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • Patients ≥ 18 and ≤ 65 years at the time of consent
• • Diagnosis of C3 Glomerulopathy as confirmed by C3 nephropathy in biopsy within 12 months prior to enrollment
• • Reduced serum C3 levels (defined as less than 0.85 x lower limit of the central laboratory normal range) at Screening
• • Patients with confirmed proteinuria
• • Willing and able to understand and complete informed consent procedures, including signing and dating the informed consent form (ICF), and comply with the study visit schedule
• • Women of child-bearing potential (WOCBP), defined as all women physiologically capable of becoming pregnant, must have a negative pregnancy test at screening and must agree to use highly effective methods of contraception during dosing and for 1 week after stopping of investigational drug
• • Males must agree to use contraceptives and refrain from donating sperm for the duration of the study
• • Patients must have documentation of previous vaccination or be willing to be vaccinated prior to dosing with NM8074. All patients will be vaccinated against Neisseria meningitidis, Streptococcus pneumoniae and Haemophilus influenzae according to the most current Advisory Committee on Immunization Practices (ACIP) recommendations.
• • Estimated glomerular filtration (eGFR) rate of ≤ 60 ml/min but ≥ 20 ml/min
• Exclusion Criteria:
• • Use of other investigational drugs at the time of enrollment
• • Patients with other renal diseases that would interfere with interpretation of the study
• • Estimated glomerular filtration rate of ≤ 20 mL/min/1.73m2 based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) at Screening
• • Has alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 5 times the upper limit of normal (xULN)
• • Has a known history of meningococcal disease or N. meningitidis
• • Currently active systemic infection or suspicion of active bacterial, viral, or fungal infection that requires antibiotic, antifungal, antiparasitic, or antiviral mediations
• • Temperature \> 38°C for more than two weeks prior to screening
• • History of renal organ transplantation
• • Pregnant, planning to become pregnant, or nursing female subjects
• • C3G patients currently under complement blocker treatments
• • Participation in any experimental small molecule or non-antibody therapy within 60 days prior to dosing on Day 1 (participation in observational studies and/or registry studies is permitted)