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OncoMatch/Clinical Trials/NCT05133531

A Study to Evaluate How Safe Pozelimab + Cemdisiran Combination Therapy is and How Well it Works in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) Who Have Not Recently Received or Have Not Received Complement Inhibitor Treatment

Is NCT05133531 recruiting? Yes, currently enrolling (May 2026). This Phase 3 trial studies multiple treatments including Ravulizumab and Pozelimab for paroxysmal nocturnal hemoglobinuria.

Phase 3RecruitingRegeneron PharmaceuticalsNCT05133531Data as of May 2026

Treatment: Ravulizumab · Pozelimab · Cemdisiran · EculizumabThis study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH and how the combination compares with 2 existing treatments: ravulizumab and eculizumab. The pozelimab + cemdisiran combination may be referred to as "study drugs". Ravulizumab and eculizumab may also be called the "comparator drug". The study is looking at several research questions, including: * How effective is the pozelimab + cemdisiran combination compared to ravulizumab? * How effective is pozelimab + cemdisiran combination compared to eculizumab? * What side effects may happen from taking the study drugs? * How much study drugs are in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the study drugs less effective or could lead to side effects)

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Extracted eligibility criteria

Prior therapy

Cannot have received: complement inhibitor (eculizumab)

Prior treatment with eculizumab within 3 months prior to screening

Cannot have received: complement inhibitor (ravulizumab)

ravulizumab within 6 months prior to screening

Cannot have received: complement inhibitor

other complement inhibitors within 5 half-lives of the respective agent prior to screening

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

US trial sites

  • The Oncology Institute of Hope & Innovation · Whittier, California

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