A Study in Adult Patients With Paroxysmal Nocturnal Hemoglobinuria (PNH) to Evaluate How Safe Long-term Treatment With Pozelimab + Cemdisiran Combination Therapy is and How Well it Works
Recruiting now · Phase 3
Conditions studied: Paroxysmal Nocturnal Hemoglobinuria
In brief
This study is researching an experimental treatment combination with two experimental drugs called pozelimab and cemdisiran. The study is focused on people with paroxysmal nocturnal hemoglobinuria (PNH). The aim of this study is to see how safe and effective the pozelimab + cemdisiran combination is for people with PNH in the long term. The pozelimab + cemdisiran combination may be referred to as "study drugs" in this section. This study is looking at several other research questions, including: * How effective is the pozelimab + cemdisiran combination? * What side effects may happen from taking the study drugs? * How much of each study drug is in the blood at different times? * Whether the body makes antibodies against the study drugs (which could make the drugs less effective or could lead to side effects)
Key facts
- Study ID
- NCT05744921
- Run by
- Regeneron Pharmaceuticals
- People needed
- 202
- Starts
- 2023-03-07
- Expected to finish
- 2028-10-10
- Last updated by the study team
- 2026-07-30
Who can join
Age: 18 and older. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Toronto General Hospital — Toronto, Ontario, Canada (enrolling)
- Semmelweis University/Semmelweis Egyetem — Budapest, Hungary (enrolling)
- Amrita Institute of Medical Sciences (AIMS) and Research Centre Aims — Kochi, Kerala, India (enrolling)
- K J Somaiya Super Specialty Hospital & Research Centre — Mumbai, Maharashtra, India (enrolling)
- Rajiv Gandhi Cancer Institute & Research Center (RGCIRC) - Rohini Campus — New Delhi, National Capital Territory of Delhi, India (enrolling)
- Postgraduate Institute of Medical Education & Research — Chandigarh, India (enrolling)
- Bhagwan Mahaveer Cancer Hospital and Research Centre (BMCHRC) — Jaipur, India (enrolling)
- Aou Careggi — Florence, Firenze, Italy (enrolling)
- SC Hematology, AOU Città della Salute e della Scienza di Torino — Torino, Italy (enrolling)
- Leeds Teaching Hospitals NHS Trust - St. James Institute of Oncology — Leeds, United Kingdom (enrolling)
- Hospital Pablo Tobon Uribe — Medellín, Antioquia, Colombia (enrolling)
- University of Tsukuba Hospital — Tsukuba, Ibaraki, Japan (enrolling)
- Jordan University Hospital (JUH) — Amman, Jordan (enrolling)
- Hospital Tg Ampuan Afzan — Kuantan, Pahang, Malaysia (enrolling)
- Hospital Queen Elizabeth — Kota Kinabalu, Sabah, Malaysia (enrolling)
- Hospital Ampang — Ampang, Selangor, Malaysia (enrolling)
- Clinica San Felipe — Lima, Peru (enrolling)
- St Lukes Medical Center — Quezon City, National Capital Region, Philippines (enrolling)
- In-Vivo Sp. z o.o. — Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland (enrolling)
- University Clinical Center Medical University of Gdansk — Gdansk, Pomeranian Voivodeship, Poland (enrolling)
- Prof Dr Ion Chiricuta Cancer Institute — Cluj-Napoca, Cluj, Romania (enrolling)
- National University Hospital — Singapore, Singapore (enrolling)
- St. Vincent Hospital — Suwon, Gyeonggi-do, South Korea (enrolling)
- Ajou University Medical Center — Suwon, Gyeonggi-do, South Korea (enrolling)
- Gachon University Gil Medical Center — Incheon, Namdong-Gu, South Korea (enrolling)
Full record on ClinicalTrials.gov
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