NCT06932744

Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy

A Randomized, Multicenter, Active-comparator Controlled, Open-label Trial to Evaluate Efficacy and Safety of MY008211A Tablets in PNH Patients Who Are Naive to Complement Inhibitor Therapy

• Status: Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 66 (estimated)
• Sponsor: Wuhan Createrna Science and Technology Co., Ltd · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.

Detailed description

This is a multi-center, randomized, open-label, active comparator-controlled, parallel group study. The purpose of this study is to determine whether MY008211A compared to eculizumab is efficacious and safe for the treatment of PNH patients who were naive to complement inhibitor therapy.

Conditions

• Paroxysmal Nocturnal Haemoglobinuria (PNH)

Interventions

Type	Name	Description
DRUG	MY008211A tablets	Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks
DRUG	Eculizumab Injection	Eculizumab Injection for 24 weeks

Timeline

• Start date: 2024-08-30
• Primary completion: 2025-12-30
• Completion: 2025-12-30
• First posted: 2025-04-17
• Last updated: 2025-05-09

Locations

2 sites across 1 country: China