ClinicalTrials.gov record NCT06932471

Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment

Record copied from ClinicalTrials.gov: Oct 10, 2026AI summaries generated: Jul 27, 2026

A Multicenter, Single-arm, Open-label Phase III Study to Evaluate Efficacy and Safety of MY008211A Tablets in Patients With PNH and Residual Anemia, Despite Treatment With Anti-C5 Antibody.

StatusRecruitingThe study is currently enrolling participants. Only the study team can say whether a particular person can join.
Study typeInterventionalA study in which researchers assign participants to one or more interventions, such as a drug, procedure, device, behavioural programme or other approach, to measure their effects.
PhasePhase 3A later-stage study, usually with more participants, designed to give stronger evidence about how well a treatment works and how safe it is. It often compares the treatment with standard care or a placebo, and results may support an application for approval.
Age18 years old to 75 years old
SexAll
LocationChina
AI summaryWhat this study is about, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

This is a multicenter, single‑arm, open‑label Phase III study giving MY008211A tablets (400 mg twice daily) to adults with PNH who remain anemic despite anti‑C5 antibody treatment. The study evaluates safety and measures hemoglobin, transfusion use, markers of hemolysis, fatigue, and vascular events, with key assessments up to Day 168. There is no placebo or comparison group.

What it is studying. The study is testing the safety and efficacy of oral MY008211A tablets in people with PNH who remain anemic despite treatment with an anti‑C5 antibody. Outcomes include whether participants reach higher hemoglobin levels without red blood cell transfusion, changes in hemoglobin and markers of hemolysis (LDH and reticulocytes), transfusion needs, patient‑reported fatigue (FACIT‑F), and rates of clinical breakthrough hemolysis and major vascular events.

What the researchers hope to learn. To evaluate whether MY008211A is safe and produces measurable improvements in hemoglobin, reduces transfusion need, and affects hemolysis markers, fatigue, and vascular event rates in PNH patients with residual anemia despite anti‑C5 therapy.

What this study is about

The study's own summary, as published on ClinicalTrials.gov. Underlined terms have a short explanation.

The main purpose of this study is to evaluate the efficacy of MY008211A in PNH patients with residual anemia despite treatment with anti-C5 antibody.

Interventions being studied

Being studied in this trial does not mean the treatment or procedure is approved or available for this condition.

Drug
  • MY008211A tablets

Eligibility

The criteria exactly as listed on ClinicalTrials.gov. Only the study team can say whether they apply to you.

Inclusion criteria

  • 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%.
  • Stable regimen of anti-C5 antibody treatment for at least 6 months before treatment, and Hb was still < 100 g/L.
  • The average hemoglobin level of at least two tests in 4 months before screening < 100 g/L.
  • The average hemoglobin level of two tests in the central laboratory during screening < 100 g/L.
  • 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 criteria

  • 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.

Study description and what participation involves

The study's detailed description, as published on ClinicalTrials.gov.

Detailed description from the registry

This is a multicenter, single-arm, open-label phase III clinical trial. The purpose of this study is to determine whether MY008211A is efficacious and safe for the treatment of PNH patients Who Are Still Anemia After Anti-C5 Antibody Treatment.

AI summaryWhat participation may involve, in plain languageShow ▾Hide ▴

AI-written from the registry record, not the study's own wording. May contain errors or omissions. Check the registry text on this page and the original record ↗ before acting on it.

Participants will take the study drug MY008211A tablets orally, 400 mg twice daily. They will attend regular clinic visits for blood tests to check hemoglobin and markers of hemolysis, periodic safety assessments, and complete questionnaires about symptoms such as fatigue. Study assessments and monitoring are scheduled through the outcome assessment period reported (up to Day 168). The study team will monitor for side effects and collect data on transfusion status and other clinical outcomes.

How the study is structured. Interventional Phase III, single‑group, open‑label study. All participants receive MY008211A tablets 400 mg orally twice daily. There is no randomized control group or masking. Main outcome windows and assessments are conducted through about Day 168 after starting treatment.

Questions you could ask

These questions are suggestions for a conversation with the study team or your own clinician, not advice.

  • The listed sites are in China. Is any of them reachable for me, and does the study help with travel?
  • Which of the eligibility criteria would need to be checked with tests before I could join?

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Important dates

Study start
Aug 30, 2024
Primary completion
Dec 30, 2025 (estimated)
Study completion
Dec 30, 2025 (estimated)
Target enrollment
20 participants (estimated)
Last updated on registry
May 9, 2025
Data verified
Oct 10, 2026

Sponsor and research team

The lead sponsor funds and oversees the trial. A pharmaceutical or biotech company sponsor typically means the study is testing that company's drug or device; a hospital, university, or government agency usually indicates investigator-initiated or publicly funded research.

Lead sponsor
Wuhan Createrna Science and Technology Co., Ltd

Central study contact

If you're interested in participating, the central contact can answer general questions about the study — including eligibility requirements and how to find a recruiting site near you. Actual eligibility is determined by the site's medical team.

Participating sites (1)

Terms used on this page · explanations by MedicalUpdates.ai

Stable regimen
A dose that has not changed for a defined period before the study starts. Studies may require this so that background treatment is relatively stable when study measurements begin.
before screening
The checks done before enrolment to see whether a person qualifies, such as tests, scans or a review of medical history.
Inclusion Criteria
The conditions a person must meet to be considered for the study, for example a confirmed diagnosis, an age range or a test result.
Exclusion Criteria
The conditions that rule a person out even if they meet the inclusion criteria, for example other illnesses, certain medicines or pregnancy.
single-arm
All participants receive the same treatment or follow the same plan. There is no comparison group within the study.
open-label
No masking is used, so the assigned intervention is not deliberately hidden from participants or study staff.

The study record on this page is reproduced from ClinicalTrials.gov, a database of the U.S. National Library of Medicine, where it was submitted by the study sponsor. MedicalUpdates.ai does not own this content, is not affiliated with or endorsed by ClinicalTrials.gov, NIH, or the U.S. Government, and does not verify the record. Plain-language notes, the glossary and the questions above are added by this site; text in the boxes marked "AI summary" was written by an AI model and may contain errors. Registry records change over time. Check the original record for the current version and discuss eligibility or participation with a qualified healthcare professional.

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