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OncoMatch/Clinical Trials/NCT07154745

A Study to Evaluate How Pozelimab + Cemdisiran Combination Therapy Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Whose Current Treatment is Not Working Efficiently

Is NCT07154745 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Pozelimab and Cemdisiran for paroxysmal nocturnal hemoglobinuria.

Phase 3RecruitingRegeneron PharmaceuticalsNCT07154745Data as of May 2026

Treatment: Pozelimab · CemdisiranThis study is researching a treatment combination with two experimental drugs called pozelimab and cemdisiran referred to as "study drugs". Researchers are looking for a better way to treat Paroxysmal Nocturnal Hemoglobinuria (PNH). The aim of the study is to see how well the pozelimab and cemdisiran combination works to lower hemolysis in participants whose PNH has been not well controlled even after taking other complement component 5 (C5) inhibitors, eculizumab/eculizumab biosimilar, ravulizumab or crovalimab. The study is looking at several other research questions, including: * What side effects may happen from taking the study drugs? * How much of the study drugs are in the blood at different times? * Whether the body makes antibodies against the study drug (which could make the study drugs not work as well or could lead to side effects)

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Extracted eligibility criteria

Biomarker criteria

Excluded: C5 mutation that is refractory to their current C5i treatment

Patients with a known or suspected C5 mutation that is refractory to their current C5i treatment as described in the protocol

Prior therapy

Must have received: C5 inhibitor (eculizumab, ravulizumab, crovalimab) — current

Currently treated with marketed eculizumab, ravulizumab, or crovalimab at the labeled dose for at least 6 months

Cannot have received: organ transplant

Receipt of an organ transplant

Cannot have received: bone marrow transplantation or other hematologic transplants

history of bone marrow transplantation or other hematologic transplants

Structured fields extracted by AI. May contain errors — verify against the official protocol.

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