Actively Recruiting
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Led by Shanghai Lanyi Therapeutics Co., Ltd. · Updated on 2026-05-14
24
Participants Needed
2
Research Sites
147 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is a multicenter, open-label, Phase Ib clinical trial designed to evaluate the safety, pharmacokinetics (PK), and pharmacodynamics (PD) of multiple doses of the humanized monoclonal antibody EA5 in adult patients with paroxysmal nocturnal hemoglobinuria (PNH).
CONDITIONS
Official Title
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female subjects aged 18 years.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- Diagnosed with PNH confirmed by flow cytometry showing a PNH clone size 10% in peripheral blood.
- Previously naive to complement inhibitor therapy or discontinued complement inhibitor therapy at least 5 half-lives before screening.
- Lactate dehydrogenase (LDH) level at least 1.5 times the upper limit of normal at screening.
- Presence of PNH-related symptoms within 3 months prior to screening or history of packed red blood cell transfusion due to PNH.
- Vaccinated against Neisseria meningitidis and Streptococcus pneumoniae according to study requirements.
- Stable dose of concomitant therapies for at least 28 days prior to first dose.
- Platelet count 30 10^9/L and absolute neutrophil count 0.5 10^9/L without recent growth factor support.
- Adequate liver and renal function as defined by study criteria.
- Agreement to use effective contraception during and for 6 months after the study.
- Ability to understand study procedures and provide informed consent.
You will not qualify if you...
- History of allogeneic bone marrow transplantation.
- History of Neisseria meningitidis infection within 6 months prior to screening.
- Known or suspected immunodeficiency or hereditary complement deficiency.
- Evidence or history of active tuberculosis without completed treatment.
- Major surgery within 3 months prior to first dose.
- Autoimmune disease or recent use of systemic immunosuppressive agents.
- Active infection or recent use of antibiotics or hospitalization for infection within specified periods.
- Fever of 386C within 7 days prior to first drug administration.
- Live-attenuated vaccine within 1 month prior to first dose.
- History of malignancy within 5 years with specified exceptions.
- Allergy or hypersensitivity to EA5 or its components.
- Contraindications to meningococcal vaccination or required antibiotic prophylaxis.
- Participation in another investigational drug trial within 3 months prior to screening.
- History of drug or alcohol abuse within specified time frames.
- Splenectomy within 6 months prior to screening.
- Positive for certain viral infections or antibodies except under specified conditions.
- History or ongoing cryoglobulinemia or high-risk myelodysplastic syndromes.
- Any condition making the subject unsuitable for trial participation as judged by the investigator.
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
The Institute of Hematology & Blood Diseases Hospital (Chinese Academy of Medical Sciences)
Tianjin, Tianjin Municipality, China, 300020
Actively Recruiting
2
The First Affiliated Hospital, Zhejiang University School of Medicine, Chengzhan Campus
Hangzhou, Zhejiang, China, 310009
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Research Team
F
Fengkui zhang, Dr.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
3
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