NCT06932744 Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complement Inhibitor Therapy
| NCT ID | NCT06932744 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Wuhan Createrna Science and Technology Co., Ltd |
| Condition | Paroxysmal Nocturnal Haemoglobinuria (PNH) |
| Study Type | INTERVENTIONAL |
| Enrollment | 66 participants |
| Start Date | 2024-08-30 |
| Primary Completion | 2025-12-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 66 participants in total. It began in 2024-08-30 with a primary completion date of 2025-12-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
The main purpose of this study is to evaluate the efficacy of MY008211A compared to eculizumab in PNH patients.
Eligibility 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06932744 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Paroxysmal Nocturnal Haemoglobinuria (PNH). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06932744 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 66 participants.
Is NCT06932744 currently recruiting?
Yes, NCT06932744 is actively recruiting participants. Contact the research team at lcyxzx@createrna.com for enrollment information.
Where is the NCT06932744 trial being conducted?
This trial is being conducted at Beijing, China, Tianjin, China.
Who is sponsoring the NCT06932744 clinical trial?
NCT06932744 is sponsored by Wuhan Createrna Science and Technology Co., Ltd. The trial plans to enroll 66 participants.