Evaluating MY008211A for treating PNH patients new to complement inhibitors
Official title: 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
Run by Wuhan Createrna Science and Technology Co., Ltd · NCT06932744 · Data updated 2026-11-12
This study is testing a new medication called MY008211A to see if it works better than the standard treatment for people with Paroxysmal Nocturnal Hemoglobinuria who haven't used complement inhibitors before.
Quick facts
| Phase | Phase 3 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Enrollment | 66 (estimated) |
| Sponsor | Wuhan Createrna Science and Technology Co., Ltd Industry-sponsored |
| Drugs / interventions | eculizumab |
| Locations | 2 sites (Beijing, Beijing Municipality and 1 other locations) |
| Status | Recruiting |
| Started | August 30, 2024 |
| Main results expected | December 30, 2025 |
| Study ends | December 30, 2025 |
| Registry record updated | May 9, 2025 |
| Trial ID | NCT06932744 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates for this study are adults aged 18 and older with a confirmed diagnosis of PNH and specific laboratory criteria.
✕Probably not a fit
Patients with severe blood cell deficiencies or a history of certain infections or malignancies may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This clinical trial aims to assess the safety and efficacy of MY008211A compared to eculizumab in patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have not previously received complement inhibitor therapy. It is a multi-center, randomized, open-label study that will involve parallel groups receiving either MY008211A tablets or eculizumab injections. The study will measure various health outcomes to determine the effectiveness of MY008211A in improving patient conditions compared to the standard treatment.
Why it matters
Potential benefit: If successful, this treatment could provide a new effective option for PNH patients who have not yet been treated with complement inhibitors.
How similar studies have gone: Other studies have shown success with complement inhibitors in treating PNH, but the efficacy of MY008211A is being specifically evaluated in this novel approach.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: 1. 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%. 2. Mean hemoglobin level \<100 g/L at screening. 3. LDH \> 1.5 x Upper Limit of Normal (ULN) at screening. 4. 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: 1. Patients with reticulocytes \<100x10\^9/L; platelets \<30x10\^9/L; neutrophils \<0.5x10\^9/L. 2. History of recurrent invasive infections caused by encapsulated organisms,e.g. meningococcus or pneumococcus. 3. Known or suspected hereditary complement deficiency. 4. Previous bone marrow or hematopoietic stem cell transplantation. 5. Previous splenectomy. 6. 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.
Where it's running
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Chinese Academy of Medical Sciences Hematology Hospital
Tianjin, Tianjin Municipality, China Recruiting -
Peking Union Medical College Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, China Not yet recruiting
Study contacts
- Study coordinator: Wuhan Createrna Science and Technology Co.,Ltd
- Email: lcyxzx@createrna.com
- Phone: 027-68788900
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Long-term safety and tolerability of MY008211A tablets for patients with PNH
This study is testing how safe and well-tolerated MY008211A tablets are for people with Paroxysmal Nocturnal Hemoglobinuria (PNH) who have already benefited from the treatment in earlier trials.
-
Evaluating MY008211A for treating anemia in PNH patients on anti-C5 therapy
This study is testing a new treatment called MY008211A to see if it can help people with PNH who still have anemia even while on anti-C5 therapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.