Pozelimab
DrugAdministered per the protocol
Other names: REGN3918
NCT Number: NCT07154745
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)
Interested in participating?
Request Info18 year and older
All sexes
Interventional
Phase 3
Hospital das Clinicas da FMRP USP, Ribeirão Preto, São Paulo, Brazil
The treatment period has two parts, a Treatment Period (TP, 28 weeks) and an Extension treatment Period (EP, 52 weeks).
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
Key Inclusion Criteria:
Key Exclusion Criteria:
Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
Administered per the protocol
Other names: REGN3918
Administered per the protocol
Other names: ALN-CC5
Time frame: From baseline to week 28
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Not requiring a Red Blood Cell (RBC) transfusion as per protocol algorithm based on hemoglobin values
Time frame: Through week 52
Participants who do not receive an RBC transfusion and have no decrease in hemoglobin level of ≥2 g/dL
Time frame: Through week 52
Time frame: Through week 52
As measured by the Functional Assessment of Chronic Illness Therapy (FACIT)-Fatigue Scale.
The FACIT-Fatigue assesses the level of fatigue using a 5-point Likert scale ranging from 0 (not at all) to 4 (very much). Scores range from 0 to 52, with higher scores indicating a higher quality of life
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: Through week 52
Time frame: From baseline to week 24 and week 52
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
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
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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