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

NCT06932744 · Status: RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 66

Last updated 2025-05-09

No results posted yet for this study

Summary

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

Conditions

  • Paroxysmal Nocturnal Haemoglobinuria (PNH)

Interventions

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

Sponsors & Collaborators

  • Wuhan Createrna Science and Technology Co., Ltd

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-30
Primary Completion
2025-12-30
Completion
2025-12-30

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06932744 on ClinicalTrials.gov