Recruiting

MY008211A Tablets for PNH Patients Naive to Complement Inhibitors

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

MY008211A tablets

+ Eculizumab Injection

Drug
Who is being recruted

Anemia+4

+ Anemia, Hemolytic

+ Bone Marrow Diseases

From 18 to 75 Years
+10 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 3
Interventional
Study Start: August 2024
See protocol details

Summary

Principal SponsorWuhan Createrna Science and Technology Co., Ltd
Study ContactWuhan Createrna Science and Technology Co.,Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: August 30, 2024

Actual date on which the first participant was enrolled.

This clinical trial is focused on testing a new tablet called MY008211A for patients with a rare blood disorder known as Paroxysmal Nocturnal Hemoglobinuria (PNH). The study specifically targets individuals who have not previously received treatments known as complement inhibitors. The goal is to see if MY008211A is safe and effective compared to an existing treatment called eculizumab. This study is important because finding effective treatments can improve the quality of life for people with PNH and offer new options for those who have never tried these types of medications before. Participants in this study are randomly assigned to receive either the MY008211A tablets or eculizumab. The study is open-label, meaning both the participants and the researchers know which treatment is being administered. The main focus is to evaluate how well MY008211A works in comparison to eculizumab and to monitor any side effects or safety concerns. By comparing the two treatments, the study aims to gather valuable information on the effectiveness and safety of the new tablet, which could lead to better treatment options for PNH patients.

Official TitleA 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
NCT06932744
Principal SponsorWuhan Createrna Science and Technology Co., Ltd
Study ContactWuhan Createrna Science and Technology Co.,Ltd
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

66 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 75 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

AnemiaAnemia, HemolyticBone Marrow DiseasesHematologic DiseasesHemic and Lymphatic DiseasesHemoglobinuria, ParoxysmalMyelodysplastic Syndromes

Criteria

4 inclusion criteria required to participate
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.

6 exclusion criteria prevent from participating
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.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

2 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
MY008211A tablets 400mg BID

Group II

Active Comparator
Eculizumab Injection

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 2 locations

Recruiting

Chinese Academy of Medical Sciences Hematology Hospital

Tianjin, ChinaOpen Chinese Academy of Medical Sciences Hematology Hospital in Google Maps
Recruiting soon

Peking Union Medical College Hospital, Chinese Academy of Medical Sciences

Beijing, China
Recruiting
2 Study Centers