NCT06687174

Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN)

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 72 (estimated)
• Sponsor: Wuhan Createrna Science and Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

Efficacy and safety of MY008211A in IgAN patients

Detailed description

This was a multicenter, randomized, double-blind, dose-ranging, parallel-group study. Two doses of MY008211A (200mg, 400mg) were compared with placebo. The study comprised a screening period of this study for 90 days, an efficacy observation period for 24 weeks, a long-term study for 80 weeks, and a follow-up period for 2 weeks.

Conditions

• IgA Nephropathy (IgAN)

Interventions

Type	Name	Description
DRUG	MY008211A tablets	MY008211A BID
DRUG	MY008211A tablets matched placebo	Matching placebo to MY008211A taken twice a day.

Timeline

• Start date: 2024-12-31
• Primary completion: 2026-06-15
• Completion: 2028-01-31
• First posted: 2024-11-13
• Last updated: 2024-11-18

Locations

1 site across 1 country: China