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MY008211A vs Eculizumab in Naive PNH
NCT06932744Phase 3
Key facts
- Status
- Recruiting
- Start
- Aug 2024
- Primary completion
- Dec 2025
- Countries
- 1
- Modality
- Small Molecules
- Drugs
- MY-008
- Conditions
- paroxysmal nocturnal hemoglobinuria (PNH)
01
Overview
Phase 3, randomised, open-label trial of MY-008 in paroxysmal nocturnal hemoglobinuria (PNH) (2 arms), sponsored by Wuhan Createrna Science and Technology Co., Ltd. Primary endpoint: Proportion of Participants With Sustained Hemoglobin Levels of ≥ 120 g/L in the Absence of Red Blood Cell Transfusions. Started Aug 2024; status: recruiting.
02
Design
2 arms- Study design
- RandomizedOpen-label
MY008211A
MY008211A tablets 400mg BID
Eculizumab
Eculizumab Injection
03
Who it enrols
Adult PNH patients naive to complement inhibitor therapy with Hb < 100 g/L, LDH > 1.5x ULN, and PNH clone size >= 10%.
04
Endpoints
Primary
Proportion of Participants With Sustained Hemoglobin Levels of ≥ 120 g/L in the Absence of Red Blood Cell Transfusions
Secondary
Proportion of subjects with an increase in hemoglobin concentration ≥ 20 g/L from baseline among subjects who do not receive RBC transfusion
Proportion of patients with LDH < 1.5 ULN among those without RBC transfusion
Change (Expressed as Percentages) in LDH level from baseline
Change in reticulocyte count from baseline
Proportion of patients without RBC transfusion
Change in FACIT-F score from baseline
The Clinical Breakthrough Hemolysis (BTH) Rate
The Major Adverse Vascular Events (MAVE) Rate
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