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
Running, not enrolling · Phase 3
Conditions studied: Paroxysmal Nocturnal Hemoglobinuria
In brief
This 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)
Key facts
- Study ID
- NCT05133531
- Run by
- Regeneron Pharmaceuticals
- People needed
- 202
- Starts
- 2022-08-01
- Expected to finish
- 2026-10-26
- Last updated by the study team
- 2026-04-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Ion Chiricuta Oncology Institute — Cluj-Napoca, Cluj, Romania
- The Oncology Institute of Hope & Innovation — Whittier, California, United States
- Centro de Estudos e Pesquisas em Hematologia e Oncologia — Santo André, São Paulo, Brazil
- A Beneficencia Portuguesa de Sao Paulo, BP Mirante — São Paulo, Brazil
- Casa de Saude Santa Marcelina — São Paulo, Brazil
- Toronto General Hospital — Toronto, Ontario, Canada
- Peking Union Medical College Hospital — Beijing, Beijing Municipality, China
- Hospital Pablo Tobon Uribe — Medellín, Antioquia, Colombia
- George Papanikolaou Hospital — Thessaloniki, Greece
- Semmelweis University — Budapest, Hungary
- Malabar Cancer Center, Kerala — Kannur, Kerala, India
- Amrita Institute of Medical Sciences (AIMS) and Research Centre Aims — Kochi, Kerala, India
- K J Somaiya Super Specialty Hospital & Research Centre — Mumbai, Maharashtra, India
- Rajiv Gandhi Cancer Institute & Research Center (RGCIRC) - Rohini Campus — New Delhi, National Capital Territory of Delhi, India
- Postgraduate Institute of Medical Education & Research (PGIMER) — Chandigarh, Punjab, India
- King George Hospital — Lucknow, Uttar Pradesh, India
- Sanjay Gandhi Postgraduate Institute of Medical Sciences — Lucknow, Uttar Pradesh, India
- Bhagwan Mahaveer Cancer Hospital and Research Centre (BMCHRC) — Jaipur, India
- Aou Careggi — Florence, Firenze, Italy
- Fondazione Policlinico Universitario A. Gemelli - IRCCS — Rome, Roma, Italy
- Hematology Citta della Salute e della Scienza di Torino — Turin, Italy
- Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital — Nagoya, Aichi-ken, Japan
- Ogaki Municipal Hospital — Ōgaki, Gifu, Japan
- University of Tsukuba Hospital — Tsukuba, Ibaraki, Japan
- Institute of Hematology and Transfusion Medicine — Warsaw, Poland
Full record on ClinicalTrials.gov
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