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

Paroxysmal nocturnal haemoglobinuria (PNH)

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

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Eculizumab Injection and a drug called MY008211A tablets for people with paroxysmal nocturnal haemoglobinuria (pnh). The study is currently recruiting participants at 2 locations. People eligible for this study include aged 18 Years to 75 Years.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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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)

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, Beijing Municipality, China

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, Tianjin Municipality, China

View Full Details on ClinicalTrials.gov

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NCT06932744