NCT05125068

Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy (IgAN)

A Phase 2a, Multicenter, Open-Label Study to Evaluate the Safety and Efficacy of AT-1501 in Patients With IgA Nephropathy

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 24 (actual)
• Sponsor: Eledon Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 99 Years
• Healthy volunteers: Not accepted

Summary

This is a phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of screening.

Detailed description

Phase 2a, multicenter, open-label study designed to evaluate the safety and efficacy of AT-1501 in patients with biopsy proven IgAN and at least 0.75 g/24 hours of protein in their urine at the time of Screening. Up to 42 eligible patients will receive one of 2 doses of AT-1501. All patients are scheduled to receive AT-1501 by intravenous infusion every 3 weeks for approximately 2 years.

Conditions

• IgA Nephropathy
• IgAN

Interventions

Type	Name	Description
DRUG	AT-1501	AT-1501 monoclonal antibody targeting CD40L given as an IV infusion

Timeline

• Start date: 2022-03-21
• Primary completion: 2023-07-31
• Completion: 2023-07-31
• First posted: 2021-11-18
• Last updated: 2024-03-26

Locations

26 sites across 10 countries: Australia, Croatia, Malaysia, New Zealand, Philippines, Poland, Spain, Sri Lanka, Thailand, United Kingdom