BridgeMD
New treatment option for PNH - Paroxysmal Nocturnal Hemoglobinuria
Official title A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
ClinicalTrials.gov ID: NCT07256301
What this study is testing
What is EA5?
EA5 is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for pnh - paroxysmal nocturnal hemoglobinuria.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Male or female people aged ≥18 years.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- Patients diagnosed with PNH, confirmed by flow cytometry demonstrating a PNH clone size (glycosylphosphatidylinositol-anchored protein-deficient...
- a) Previously naive to complement inhibitor therapy; or
- b) Previously treated with a complement inhibitor, which has been discontinued for ≥5 half-lives prior to screening.
You likely can't join if
- History of allogeneic bone marrow transplantation.
- History of Neisseria meningitidisinfection within 6 months prior to screening and before the first dose.
- Known or suspected immunodeficiency (e.g., history of frequent or recurrent infections).
- Known or suspected hereditary complement deficiency.
- Evidence of active tuberculosis (TB) within 6 months prior to screening, or a history of active TB without having completed an appropriate...
- History of major surgery (Grade 3 or 4 surgery) within 3 months prior to the first dose.
See the full eligibility criteria
Who can join
- Male or female people aged ≥18 years.
- Body weight between 40 kg and 100 kg (inclusive) at screening.
- Patients diagnosed with PNH, confirmed by flow cytometry demonstrating a PNH clone size (glycosylphosphatidylinositol-anchored protein-deficient granulocytes or monocytes) of ≥10% in peripheral blood, and meeting one of...
- a) Previously naive to complement inhibitor therapy; or
- b) Previously treated with a complement inhibitor, which has been discontinued for ≥5 half-lives prior to screening.
- Lactate dehydrogenase (LDH) level ≥1.5 times the upper limit of normal (ULN) at screening.
- Presence of one or more of the following PNH-related signs or symptoms within 3 months prior to screening: fatigue, hemoglobinuria, abdominal pain, shortness of breath (dyspnea), anemia (hemoglobin \<10 g/dL), history...
- Vaccination against Neisseria meningitidis(serogroups A, C, W, Y) within \<3 years prior to the initiation of study treatment; OR if not previously vaccinated, receipt of the meningococcal vaccine (MPV-ACYW) at least 14...
- Vaccination against Streptococcus pneumoniaeaccording to national vaccination recommendations (e.g., ACIP guidelines). OR if not previously vaccinated, receipt of the pneumococcal vaccine at least 14 days prior to the...
- For patients receiving concomitant therapies (e.g., immunosuppressants, corticosteroids, iron supplements, anticoagulants, erythropoiesis-stimulating agents): the dose must have been stable for ≥28 days prior to the...
- Platelet count ≥30 × 10\^9/L at screening (without transfusion support within 7 days), and absolute neutrophil count (ANC) ≥0.5 × 10\^9/L (without short-acting granulocyte colony-stimulating factor (G-CSF) within 14...
- Adequate liver function, defined as alanine aminotransferase (ALT) ≤3 × ULN, OR both direct bilirubin and alkaline phosphatase (ALP) ≤2 × ULN at screening.
- Adequate renal function, defined as serum creatinine ≤2.5 × ULN and an estimated creatinine clearance ≥30 mL/min as calculated by the Cockcroft-Gault formula.
- Male people must agree to use effective contraception (including vasectomy, abstinence, or condom) from screening until 6 months after the final study intervention. Women of childbearing potential (WOCBP) must have a...
- Ability to understand the procedures and methods of the study, willingness to provide written informed consent, and commitment to strictly adhere to the clinical study protocol to complete the study.
What rules you out
- History of allogeneic bone marrow transplantation.
- History of Neisseria meningitidisinfection within 6 months prior to screening and before the first dose.
- Known or suspected immunodeficiency (e.g., history of frequent or recurrent infections).
- Known or suspected hereditary complement deficiency.
- Evidence of active tuberculosis (TB) within 6 months prior to screening, or a history of active TB without having completed an appropriate, documented course of treatment; OR chest X-ray (posteroanterior and lateral) or...
- History of major surgery (Grade 3 or 4 surgery) within 3 months prior to the first dose.
- Presence of an autoimmune disease, OR use of systemic immunosuppressive/immunomodulatory agents (including, but not limited to, methotrexate, cyclosporine, mycophenolate, tacrolimus, penicillamine, sulfasalazine...
- Active systemic bacterial, viral, or fungal infection within 14 days prior to the first dose; OR requirement for hospitalization or intravenous antibiotic therapy for an infection between 28 days prior to screening and...
- Occurrence of fever (≥38°C) within 7 days prior to the first drug administration.
- Administration of any live-attenuated vaccine within 1 month prior to the first dose.
- History of malignancy within 5 years prior to screening and before the first dose, with the following exceptions: patients with any malignancy that has been treated with curative intent and who have been disease-free...
- History of allergy to any component of EA5, including a history of hypersensitivity to human, humanized, or murine monoclonal antibodies, or known hypersensitivity to any excipient of the product.
- Any contraindication to receiving the meningococcal vaccination and/or antibiotic prophylaxis (e.g., beta-lactam antibiotics, ciprofloxacin) as required by the study protocol.
- Participation in another treatment therapeutic clinical trial involving an investigational drug or receipt of any experimental therapy within 3 months (or within 5 half-lives of the investigational agent, whichever is...
- History of drug abuse within 12 months prior to screening, as judged by the investigator.
- Alcohol abuse, or regular alcohol consumption exceeding 14 units per week within 6 months prior to screening (1 unit of alcohol ≈ 360 mL of beer, or 45 mL of 40% spirits, or 150 mL of wine).
- Splenectomy performed within ≤6 months prior to screening.
- Positive for hepatitis C virus (HCV) antibody at screening (except for those with a negative HCV RNA result), positive for human immunodeficiency virus (HIV) antibody, positive for anti-Treponema pallidumantibody...
- History of or ongoing cryoglobulinemia at the time of screening.
- History of myelodysplastic syndromes (MDS), with a Revised International Prognostic Scoring System (IPSS-R) risk category of Intermediate, High, or Very High.
- Any other condition that, in the opinion of the investigator, renders the subject unsuitable for participation in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Tianjin, Tianjin Municipality, China
- Hangzhou, Zhejiang, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Tianjin, Tianjin Municipality, China; Hangzhou, Zhejiang, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.