RecruitingPhase 3NCT05744921

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

An Open-Label Extension Study to Evaluate the Long-Term Safety, Tolerability, and Efficacy of Pozelimab and Cemdisiran Combination Therapy in Patients With Paroxysmal Nocturnal Hemoglobinuria


Sponsor

Regeneron Pharmaceuticals

Enrollment

202 participants

Start Date

Mar 7, 2023

Study Type

INTERVENTIONAL

Conditions

Summary

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)


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called Cemdisiran and a drug called Pozelimab for people with paroxysmal nocturnal hemoglobinuria. The study is currently recruiting participants at 44 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPozelimab

Administered per the protocol

DRUGCemdisiran

Administered per the protocol


Locations(46)

Toronto General Hospital

Toronto, Ontario, Canada

Hospital Pablo Tobon Uribe

Medellín, Antioquia, Colombia

Semmelweis University/Semmelweis Egyetem

Budapest, Hungary

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

Chandigarh, India

Bhagwan Mahaveer Cancer Hospital and Research Centre (BMCHRC)

Jaipur, India

Aou Careggi

Florence, Firenze, Italy

SC Hematology, AOU Città della Salute e della Scienza di Torino

Torino, Italy

Japanese Red Cross Aichi Medical Center Nagoya Daini Hospital

Nagoya, Aichi-ken, Japan

University of Tsukuba Hospital

Tsukuba, Ibaraki, Japan

Jordan University Hospital (JUH)

Amman, Jordan

Hospital Tg Ampuan Afzan

Kuantan, Pahang, Malaysia

Hospital Queen Elizabeth

Kota Kinabalu, Sabah, Malaysia

Hospital Ampang

Ampang, Selangor, Malaysia

Clinica San Felipe

Lima, Peru

St Lukes Medical Center

Quezon City, National Capital Region, Philippines

In-Vivo Sp. z o.o.

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland

University Clinical Center Medical University of Gdansk

Gdansk, Pomeranian Voivodeship, Poland

Szpital Uniwersytecki Nr2 Bydgoszcz

Bydgoszcz, Poland

Prof Dr Ion Chiricuta Cancer Institute

Cluj-Napoca, Cluj, Romania

National University Hospital

Singapore, Singapore

St. Vincent Hospital

Suwon, Gyeonggi-do, South Korea

Ajou University Medical Center

Suwon, Gyeonggi-do, South Korea

Gachon University Gil Medical Center

Incheon, Namdong-Gu, South Korea

Pusan National University Hospital

Busan, South Korea

Severance Hospital Yonsei University Health System

Seoul, South Korea

Samsung Medical Center

Seoul, South Korea

The Catholic University of Korea, Seoul St. Mary's Hospital

Seoul, South Korea

Ewha Womans University Mokdong Hospital

Seoul, South Korea

Hospital Universitario Basurto

Bilbao, Vizcaya, Spain

Hospital Clinic de Barcelona

Barcelona, Spain

China Medical University Hospital

Taichung, Central Taiwan, Taiwan

Chang Gung Memorial Hospital - Linkou Branch

Taoyuan, Hunan Province, Taiwan

Changhua Christian Hospital

Changhua, Taiwan

Hualien Tzu Chi Hospital

Hualien City, Taiwan

National Taiwan University Hospital

Taipei, Taiwan

Tri-Service General Hospital

Taipei, Taiwan

Prince Of Songkla Hospital, Prince Of Songkhla University

Hat Yai, Changwat Songkhla, Thailand

King Chulalongkorn Memorial Hospital

Bangkok, Thailand

Chiang Mai University

Chiang Mai, Thailand

Faculty of Medicine Khon Kaen University

Khon Kaen, Thailand

Ege University Faculty of Medicine

Bornova, İzmir, Turkey (Türkiye)

Istanbul University

Istanbul, Turkey (Türkiye)

Leeds Teaching Hospitals NHS Trust - St. James Institute of Oncology

Leeds, United Kingdom

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NCT05744921


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