Study of NM8074 in Adult C3 Glomerulopathy Patients

NCT ID: NCT05647811

Last Updated: 2024-11-18

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2025-11-30
• Study Completion Date: 2027-07-31

Brief Summary

This is a Phase Ib, open-label, dose-escalation study designed to evaluate the safety, efficacy, and immunogenicity of NM8074 administered intravenously to patients with C3 Glomerulopathy.

Detailed Description

The proposed study, NM8074-C3G-101, will enroll a planned number of 18 patients, with the potential to enroll more patients. There will be 3 cohorts with 6 patients each dosed at 5, 10, or 20 mg/kg depending on which cohort they are assigned to. Enrollment in the subsequent higher dose level cohort will occur after the previous cohort has been evaluated for safety.

Conditions

C3 Glomerulopathy

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: SEQUENTIAL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Cohort 1

6 subjects will receive NM8074 at 5 mg/kg weekly.

Group Type: EXPERIMENTAL

NM8074

Intervention Type: DRUG

NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Cohort 2

6 subjects will receive NM8074 at 10 mg/kg every 2 weeks.

Group Type: EXPERIMENTAL

NM8074

Intervention Type: DRUG

NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Cohort 3

6 subjects will receive NM8074 at 20 mg/kg every 2 weeks.

Group Type: EXPERIMENTAL

NM8074

Intervention Type: DRUG

NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Interventions

NM8074

NM8074 will be administered as an intravenous infusion. Multiple dosing duration will range from 5 to 9 weeks.

Intervention Type: DRUG

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)

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

NovelMed Therapeutics

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Rekha Bansal

Role: CONTACT

clinicalsae@novelmed.com

216-440-2696

Other Identifiers

NM8074-C3G-101

Identifier Type: -

Identifier Source: org_study_id