RecruitingPhase 3NCT06932744
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
Sponsor
Wuhan Createrna Science and Technology Co., Ltd
Enrollment
66 participants
Start Date
Aug 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
Eligibility
Min Age: 18 YearsMax Age: 75 Years
Inclusion Criteria4
- Male and female participants ≥ 18 years of age and BMI ≥ 18.0 kg/m2 with a diagnosis of PNH confirmed by high-sensitivity flow cytometry with clone size ≥ 10%.
- Mean hemoglobin level <100 g/L at screening.
- LDH > 1.5 x Upper Limit of Normal (ULN) at screening.
- Vaccination against Neisseria meningitidis infection is required prior to the start of study treatment. If not received previously, vaccination against Streptococcus pneumoniae and Haemophilus influenzae infections should be given.
Exclusion Criteria6
- Patients with reticulocytes <100x10\^9/L; platelets <30x10\^9/L; neutrophils <0.5x10\^9/L.
- History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus.
- Known or suspected hereditary complement deficiency.
- Previous bone marrow or hematopoietic stem cell transplantation.
- Previous splenectomy.
- A history of malignancy within 5 years before screening, except cured local basal cell carcinoma of the skin and carcinoma in situ of the cervix.
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Interventions
DRUGMY008211A tablets
Participants will receive MY008211A at a dose of 400 mg orally b.i.d for 24 weeks
DRUGEculizumab Injection
Eculizumab Injection for 24 weeks
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06932744