Clinical Trials Logo
  1. Home
  2. Other
  3. 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 — ACCESS-1  

Paroxysmal Nocturnal Hemoglobinuria Clinical Trial

Official title:
A Randomized, Open-Label, C5 Inhibitor-Controlled Study to Evaluate the Efficacy and Safety of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria Who Are Complement Inhibitor Treatment-Naive or Have Not Recently Received Complement Inhibitor Therapy

Clinical Trial Summary

This study is researching a clinical treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on patients with paroxysmal nocturnal hemoglobinuria (PNH). The aim of the study is to see how safe and effective the pozelimab + cemdisiran combination is for patients with PNH and how the combination compares with 2 existing treatments, one called ravulizumab and the other called 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)

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05133531
Study type Interventional
Source Regeneron Pharmaceuticals
Contact Clinical Trials Administrator
Phone 844-734-6643
Email clinicaltrials@regeneron.com
Status Recruiting
Phase Phase 3
Start date August 1, 2022
Completion date March 29, 2027
View Details
See also
  Status Clinical Trial Phase
Recruiting NCT04432584 - A Study Evaluating The Safety, Pharmacokinetics, and Efficacy Of Crovalimab Versus Eculizumab In Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Currently Treated With Complement Inhibitors Phase 3
Completed NCT05828485 - Effect of Food on Pharmacokinetics of MY008211A Tablets in Healthy Adult Subjects Phase 1
Recruiting NCT02179359 - Hematopoietic Stem Cell Transplant for High Risk Hemoglobinopathies N/A
Active, not recruiting NCT04434092 - A Phase III Study Evaluating the Efficacy and Safety of Crovalimab Versus Eculizumab in Participants With Paroxysmal Nocturnal Hemoglobinuria (PNH) Not Previously Treated With Complement Inhibitors. Phase 3
Terminated NCT05131204 - Efficacy and Safety of the Combination of Pozelimab and Cemdisiran Versus Continued Eculizumab or Ravulizumab Treatment in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria Phase 3
Recruiting NCT01374360 - Paroxysmal Nocturnal Hemoglobinuria (PNH) Registry
Active, not recruiting NCT05389449 - A Long-term Safety and Efficacy Study of Danicopan as an Add-on Therapy to Complement Component 5 Inhibitor (C5i) in Participants With PNH Phase 3
Recruiting NCT06100900 - Dose Escalation of BCX10013 in Subjects With Paroxysmal Nocturnal Hemoglobinuria Phase 1
Completed NCT01272817 - Nonmyeloablative Allogeneic Transplant N/A
Completed NCT06326814 - A Study to Test if SAR443809 is Tolerated and Safe When Taken as a Single Dose in Healthy Adults Phase 1
Completed NCT04463056 - Efficacy and Safety of Elizaria® vs. Soliris® in Patients With PNH Phase 3
Recruiting NCT05476887 - To Evaluate the Safety, Tolerability, Pharmacokinetics, Pharmacodynamics, and Efficacy of KP104 Phase 2
Completed NCT01192399 - Safety and Efficacy Study of Eculizumab in Paroxysmal Nocturnal Hemoglobinuria Patients Phase 2
Active, not recruiting NCT06051357 - Proof of Concept Study to Assess the Efficacy, Safety of HRS-5965 in Patients With Paroxysmal Nocturnal Hemoglobinuria Phase 2
Recruiting NCT06154512 - A Real-world, Multi-center, Prospective, Observational Study for PNH in China
Completed NCT04128943 - Electronic Patient-reported Outcome Monitoring in Aplastic Anemia and Paroxysmal Nocturnal Hemoglobinuria
Active, not recruiting NCT03329365 - Paroxysmal Nocturnal Hemoglobinuria in ESUS & ETUS
Recruiting NCT05755867 - Global PNH Patient Registry
Completed NCT04679103 - A Safety and Immunogenicity Study in Long-term Treatment of Eculizumab (JSC "GENERIUM", Russian Federation) Phase 3
Completed NCT05642585 - A Study of Single-dose MY008211A in Healthy Adults Phase 1