NCT06454110

Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

A Phase II, Open-Label Study of NM8074 in Patients With Immunoglobulin A Nephropathy (IgAN)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 10 (estimated)
• Sponsor: NovelMed Therapeutics · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

This is a Phase II, open-label study designed to To evaluate the safety and efficacy of NM8074 in reducing proteinuria relative to baseline in IgAN patients after 99 days of treatment.

Detailed description

The proposed study, NM8074-IgAN-601, will enroll a planned total of 10 patients as subjects for the trial. All subjects will be administered 17 mg/kg of NM8074 intravenously every week, for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Conditions

• IgA Nephropathy

Interventions

Type	Name	Description
DRUG	NM8074	NM8074 will be administered as an intravenous infusion. All subjects will be administered 17 mg/kg of NM8074 intravenously weekly for a total of 15 doses from Day 1 to Day 99 of the Treatment Period.

Timeline

• Start date: 2028-02-01
• Primary completion: 2030-12-01
• Completion: 2031-12-01
• First posted: 2024-06-12
• Last updated: 2026-04-13

Regulatory

• FDA-regulated drug study