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NCT06134414
A Multi-center, Randomized, Parallel, Open-label Clinical Phase II Study, to Evaluate the Efficacy and Safety of MY008211A in Adult Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients With Signs of Active Hemolysis
Phase 2 trial testing MY008211A tablets in Paroxysmal Nocturnal Hemoglobinuria (PNH) in 40 participants. Not yet recruiting.
1 July 2027
Quick facts
| Lead sponsor | Wuhan Createrna Science and Technology Co., Ltd |
|---|---|
| Phase | Phase 2 |
| Status | Not yet recruiting |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | none |
| Primary purpose | treatment |
| Enrollment | 40 |
| Start date | 1 December 2025 |
| Primary completion | 1 July 2027 |
| Estimated completion | 1 December 2027 |
Drugs / interventions tested
- MY008211A tablets — full drug profile →
Conditions studied
- Paroxysmal Nocturnal Hemoglobinuria (PNH) — all drugs for Paroxysmal Nocturnal Hemoglobinuria (PNH) →
Sponsor
Wuhan Createrna Science and Technology Co., Ltd — full company profile →
Who can join
Adults 18 to 75, any sex, with Paroxysmal Nocturnal Hemoglobinuria (PNH). Patients with the condition only — healthy volunteers not accepted.
What's being measured
Primary outcomes are the specific endpoints the trial is designed to prove or disprove.
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The proportion of subjects with an increase in hemoglobin concentration ≥ 20 g/L from baseline among subjects who do not receive RBC transfusion after 4 weeks of dosing
Time frame: Day 70
Proportion of participants achieving a sustained increase from baseline in hemoglobin levels of ≥ 20 g/L assessed , in the absence of red blood cell transfusions
Sponsor's own description
The main purpose of this study is to evaluate the efficacy of MY008211A in adult patients with PNH, showing signs of active hemolysis.
Publications & conference data
2 peer-reviewed publications reference this trial (live from Europe PMC):
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Factor B as a therapeutic target for the treatment of complement-mediated diseases.
Kavanagh D, Barratt J, Schubart A, Webb NJA, et al · · 2025 · cited 10× · PMID 40028332 · DOI 10.3389/fimmu.2025.1537974 -
The varieties of therapeutic experience: navigating treatment options for patients with PNH.
Bienz M, Patriquin CJ. · · 2025 · PMID 41348037 · DOI 10.1182/hematology.2025000701
Verify or expand the search:
- PubMed search for NCT06134414
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
Other trials of MY008211A tablets
Trials testing the same drug.
- NCT06687174 — Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) · Phase 2 · not yet recruiting
- NCT06933914 — Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 2, PHASE3 · recruiting
- NCT06932744 — Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complem · Phase 3 · recruiting
- NCT06932471 — Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment · Phase 3 · recruiting
- NCT06543459 — To Evaluate the Effect of Single Oral Dose of MY008211A Tablets on QTc Interval in Healthy Subjects · Phase 1 · not yet recruiting
Other recruiting trials for Paroxysmal Nocturnal Hemoglobinuria (PNH)
Currently open trials in the same condition.
- NCT07187401 — A First-in-Human Safety and Efficacy Study of ALN-CFB, a Small Interfering RNA (siRNA) Targeting Complement Factor B, in · Phase 1, PHASE2 · recruiting
- NCT07229235 — REAL-CARE: Real-world Effectiveness of Iptacopan in Italian Patients With Paroxysmal Nocturnal Hemoglobinuria · recruiting
- NCT06934967 — Study to Assess the Pharmacokinetics, Safety, and Tolerability of Iptacopan in Pediatric PNH Patients · Phase 3 · recruiting
- NCT06312644 — Study of Ultomiris® (Ravulizumab) Safety in Pregnancy · recruiting
- NCT06933914 — Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 2, PHASE3 · recruiting
Other Wuhan Createrna Science and Technology Co., Ltd trials
Trials by the same sponsor.
- NCT06687174 — Study to Evaluate the Efficacy and Safety of MY008211A in Subjects with Primary Immunoglobulin a Nephropathy (IgAN) · Phase 2 · not yet recruiting
- NCT06716970 — QR12000 Compound Tablets in Patients with Moderate to Severe Essential Hypertension · Phase 3 · not yet recruiting
- NCT06933914 — Long-term Safety and Tolerability of MY008211A Tablets in Patients With Paroxysmal Nocturnal Hemoglobinuria · Phase 2, PHASE3 · recruiting
- NCT06932744 — Study of Safety and Efficacy of MY008211A in Paroxysmal Nocturnal Hemoglobinuria (PNH) Patients Who Are Naive to Complem · Phase 3 · recruiting
- NCT06932471 — Study of Safety and Efficacy of MY008211A in Patients With Residual Anemia Despite Anti-C5 Antibody Treatment · Phase 3 · recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT06134414 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Wuhan Createrna Science and Technology Co., Ltd
- Last refreshed: 27 July 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT06134414.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing