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A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Sponsor: argenx
Summary
The main purpose of this study is to look at the effect (efficacy) and safety of efgartigimod IV in participants with primary immune thrombocytopenia (ITP). After an up to 2 weeks screening period, eligible participants will be randomized in a 2:1 ratio to receive either efgartigimod IV or placebo IV, respectively during the double-blinded treatment period (DBTP). At the end of the treatment period (up to 24 weeks), all participants will receive efgartigimod IV during the first 52-week open-label treatment period (OLTP1). At the end of the first OLTP1, participants may begin a second 52-week OLTP2. After the OLTP2, the participants will enter a follow-up period (approximately 8 weeks) while off study drug. The participants will be in the study for up to 138 weeks. More information can be found here: https://clinicaltrials.argenx.com/advancenext
Official title: A Phase 3, Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Arm Study Followed by an Open-Label Arm to Evaluate the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
69
Start Date
2024-10-18
Completion Date
2028-06
Last Updated
2026-03-11
Healthy Volunteers
No
Conditions
Interventions
Efgartigimod IV
Intravenous infusion of efgartigimod
Placebo IV
Intravenous infusion of placebo
Locations (94)
Mayo Clinic Hospital Scottsdale
Phoenix, Arizona, United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California, United States
Sharp Memorial Hospital
Oceanside, California, United States
University of Colorado Hospital
Aurora, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Georgetown University Hospital
Washington D.C., District of Columbia, United States
The University of Chicago Medicine
Chicago, Illinois, United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa, United States
Tulane University
New Orleans, Louisiana, United States
Henry Ford Health
Detroit, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Regional Cancer Care Associates, LLC (RCCA)
Little Silver, New Jersey, United States
Clinical Research Alliance Inc.
Westbury, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina, United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio, United States
Ohio State University Hospital East
Columbus, Ohio, United States
INTEGRIS Cancer Institute of Oklahoma
Oklahoma City, Oklahoma, United States
Allgemeines Krankenhaus der Stadt Linz
Linz, Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria
Klinikum Kreuzschwestern Wels
Wels, Austria
Acibadem City clinic Tokuda hospital
Sofia, Bulgaria
UMHAT Aleksandrovska
Sofia, Bulgaria
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
Sofia, Bulgaria
National Specialized Hospital for Active Treatment of Hematology Diseases
Sofia, Bulgaria
UMHAT SofiaMed
Sofia, Bulgaria
University Hospital Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, Bulgaria
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University
Beijing, China
Peking University Third Hospital
Beijing, China
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, China
The Affiliated Hospital of Chengde Medical University
Chengde, China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huai'an, China
Huizhou Central People's Hospital
Huizhou, China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, China
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
Wuhan, China
Wuxi People's Hospital (Wuxi No.1 People's Hospital)
Wuxi, China
Affiliated Hospital of Jiangsu University
Zhenjiang, China
University Hospital Center Zagreb
Zagreb, Croatia
Fakultni Nemocnice Ostrava
Ostrava, Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, Czechia
CHU d'Amiens-Picardie - Hopital SUD
Amiens, France
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
Créteil, France
Centre Hospitalier Universitaire Dijon Bourgogne Medecine Interne et Immunologie Clinique
Dijon, France
University Hospital Carl Gustav Carus
Dresden, Germany
Universitaetsklinikum Essen (AoR)
Essen, Germany
Semmelweis University-Internal Medicine and Haematology
Budapest, Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, Hungary
Mater Misericordiae University Hospital
Dublin, Ireland
St James's Hospital - Cancer Clinical Trials Office
Dublin, Ireland
Azienda ULSS 7 Pedemontana
Bassano del Grappa, Italy
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, Italy
AO Maggiore Della Carita
Novara, Italy
U.O.C. Ematologia Ospedale Santa Maria delle Croci
Ravenna, Italy
Arcispedale Santa Maria Nuova (ASMN) Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
Reggio Emilia, Italy
A.O.U. Citta della Salute e della Scienza di Torino
Torino, Italy
AO Ordine Mauriziano di Torino
Torino, Italy
Azienda Sanitaria Universitaria Integrata
Trieste, Italy
ASST Sette Laghi Ospedale di circolo e Fondazione Macchi
Varese, Italy
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, Poland
Pratia Onkologia Katowice
Katowice, Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, Poland
NZOZ Neuromed M. i M. Nastaj Sp.P.
Lublin, Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie Centrum Innowacyjnych Terapii
Lublin, Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sącz, Poland
Wojewodzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
Torun, Poland
Unidade Local de Saude de Braga
Braga, Portugal
Unidade Local de Saude Gaia e Espinho, E.P.E.
Vila Nova de Gaia, Portugal
Spitalul Clinic Coltea, Clinica de Hematologie
Bucharest, Romania
Spitalul Clinic Colentina
Bucharest, Romania
Spitalul Clinic Judetean de Urgenta Sibiu (SCJS) (Clinical County Hospital Sibiu)
Sibiu, Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures
Târgu Mureş, Romania
Clinical Center of Serbia
Belgrade, Serbia
University Clinical Centre of Kragujevac
Kragujevac, Serbia
Clinical Center of Nis
Niš, Serbia
University Clinical Hospital Center Zemun
Zemun, Serbia
General Hospital Djordje Joanovic
Zrenjanin, Serbia
Complejo Hospitalario Universitario A Coruna
A Coruña, Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat, Spain
Hospital Universitario Ramon y Cajal
Madrid, Spain
Hospital General Universitario Morales Meseguer
Murcia, Spain
University Hospital Quironsalud Madrid
Pozuelo de Alarcón, Spain
Hospital Clinico Universitario - University of Valencia
Valencia, Spain
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, United Kingdom
Glasgow Royal Infirmary - North Glasgow University Hospital Division
Glasgow, United Kingdom
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
Leicester, United Kingdom
Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust
London, United Kingdom
Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust
London, United Kingdom
Royal Cornwall Hospital (RCH)
Truro, United Kingdom