RecruitingPhase 3NCT07154745

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

A Single Arm Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria With Inadequate Control of Intravascular Hemolysis on Currently Available C5 Inhibitor Therapy


Sponsor

Regeneron Pharmaceuticals

Enrollment

35 participants

Start Date

Jun 11, 2026

Study Type

INTERVENTIONAL

Conditions

Summary

This 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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cemdisiran and a drug called Pozelimab for people with paroxysmal nocturnal hemoglobinuria. The study is currently recruiting participants at 19 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPozelimab

Administered per the protocol

DRUGCemdisiran

Administered per the protocol


Locations(19)

Hospital das Clinicas da FMRP USP

Ribeirão Preto, São Paulo, Brazil

Faculdade de Medicina do ABC

Santo André, São Paulo, Brazil

CISSS-CA

Lévis, Quebec, Canada

Universita Cattolica del Sacro Cuore - Policlinico Universitario A. Gemelli

Rome, Lazio, Italy

AOU Careggi

Florence, Tuscany, Italy

SC Hematology, AOU Città della Salute e della Scienza di Torino

Torino, Italy

In-Vivo Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

Seoul National University Hospital

Seoul, South Korea

Severance Hospital

Seoul, South Korea

Seoul St. Mary's Hospital - The Catholic University of Korea

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

Institut Catala d'Oncologia

Barcelona, Spain

Hospital San Pedro de Alcantara

Cáceres, Spain

Hospital General JM Morales Meseguer

Murcia, Spain

Hospital Universitario de Salamanca

Salamanca, Spain

Istanbul University Istanbul Faculty of Medicine

Istanbul, Turkey (Türkiye)

Ege University

Izmir, Turkey (Türkiye)

View Full Details on ClinicalTrials.gov

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NCT07154745


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