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New treatment option for Paroxysmal Nocturnal Hemoglobinuria
Official title 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
ClinicalTrials.gov ID: NCT07154745
What this study is testing
What is Pozelimab?
Pozelimab is an investigational medicine, being studied as a potential treatment for paroxysmal nocturnal hemoglobinuria.
Also referred to as REGN3918.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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).
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Diagnosis of PNH confirmed by a history of high-sensitivity flow cytometry from prior testing
- Currently treated with marketed eculizumab, ravulizumab, or crovalimab at the labeled dose for at least 6 months
- LDH persistently \> 1.5 × Upper Limit of Normal (ULN) in the previous 6 months that the Principal Investigator (PI) attributes is due to...
- At least 2 screening LDH values from different visits as described in the protocol
- Willing and able to comply with clinic/remote visits and study-related procedures, including completion of the full series of meningococcal...
You likely can't join if
- Receipt of an organ transplant, history of bone marrow transplantation or other hematologic transplants
- Body weight \<40 kilograms at screening visit
- Patients with a known or suspected C5 mutation that is refractory to their current C5i treatment as described in the protocol
- Any active or ongoing infection within 2 weeks of screening or during the screening period or any recent infection as described in the protocol
- Known hereditary complement deficiency Note: Other protocol-defined Inclusion/ Exclusion Criteria apply
The study team makes the final eligibility decision.
Where it's taking place
- Ribeirão Preto, São Paulo, Brazil
- Santo André, São Paulo, Brazil
- Lévis, Quebec, Canada
- Rome, Lazio, Italy
- Florence, Tuscany, Italy
- Torino, Italy
- Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
- Seoul, South Korea
- Bilbao, Vizcaya, Spain
- Barcelona, Spain
- Cáceres, Spain
- Murcia, Spain
- Salamanca, Spain
- Istanbul, Turkey (Türkiye)
- Izmir, Turkey (Türkiye)
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ribeirão Preto, São Paulo, Brazil; Santo André, São Paulo, Brazil; Lévis, Quebec, Canada; Rome, Lazio, Italy; Florence, Tuscany, Italy; Torino, Italy and 9 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.