A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturna… (NCT07256301) | Clinical Trial Compass
RecruitingPhase 1
A Phase Ib, Multicenter, Open-Label Study of Multiple-Dose EA5 in Adults With Paroxysmal Nocturnal Hemoglobinuria (PNH)
China24 participantsStarted 2024-01-03
Plain-language summary
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).
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Male or female subjects 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 the following criteria:
* 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 of major thrombotic event (including thrombosis), dysphagia, or erectile dysfunction; or a history of packed red blood cell (pRBC) transfusion due to PNH.
* 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 days prior to the first dose of the investigational product. If the vaccine is administered within 14 days before dosing, antibiotic prophylaxis must be provided until 2 weeks post-vaccination.
* Vaccination against Streptococcus pneumoniaeaccording to n…
What they're measuring
1
Number of Participants With Treatment Emergent Adverse Events (TEAEs)