A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
Start Date
10/18/2024
Completion Date
6/1/2028
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
Eligibility Criteria
Age Range: 18 years to No maximum
Interventions
Efgartigimod IV
Placebo IV
Conditions
Locations
Mayo Clinic Hospital Scottsdale
Phoenix, Arizona 85054
United States
University of Southern California Norris Comprehensive Cancer Center
Los Angeles, California 90033
United States
Sharp Memorial Hospital
Oceanside, California 92056
United States
University of Colorado Hospital
Aurora, Colorado 80045
United States
Yale University School of Medicine
New Haven, Connecticut 06510
United States
Georgetown University Hospital
Washington D.C., District of Columbia 20007
United States
The University of Chicago Medicine
Chicago, Illinois 60637
United States
The University of Iowa Hospitals & Clinics
Iowa City, Iowa 52242
United States
Tulane University
New Orleans, Louisiana 70112
United States
Henry Ford Health
Detroit, Michigan 48202
United States
University of Minnesota
Minneapolis, Minnesota 55422
United States
Regional Cancer Care Associates, LLC (RCCA)
Little Silver, New Jersey 07739
United States
Clinical Research Alliance Inc.
Westbury, New York 11590
United States
Duke University Medical Center
Durham, North Carolina 27710
United States
Brody School of Medicine at East Carolina University
Greenville, North Carolina 27834
United States
University Hospitals Cleveland Medical Center
Cleveland, Ohio 44106
United States
Ohio State University Hospital East
Columbus, Ohio 43203
United States
INTEGRIS Cancer Institute of Oklahoma
Oklahoma City, Oklahoma 73109
United States
Allgemeines Krankenhaus der Stadt Linz
Linz, 4020
Austria
Ordensklinikum Linz GmbH Elisabethinen
Linz, 4020
Austria
Klinikum Kreuzschwestern Wels
Wels, 4600
Austria
Acibadem City clinic Tokuda hospital
Sofia, 1407
Bulgaria
UMHAT Aleksandrovska
Sofia, 1431
Bulgaria
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
Sofia, 1431
Bulgaria
National Specialized Hospital for Active Treatment of Hematology Diseases
Sofia, 1797
Bulgaria
UMHAT SofiaMed
Sofia, 1797
Bulgaria
University Hospital Prof. Dr. Stoyan Kirkovich AD
Stara Zagora, 6003
Bulgaria
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University
Beijing, 100050
China
Peking University Third Hospital
Beijing, 100191
China
The First Affiliated Hospital Of Bengbu Medical College
Bengbu, 233004
China
The Affiliated Hospital of Chengde Medical University
Chengde, 067020
China
The Affiliated Hospital of Inner Mongolia Medical University
Hohhot, 010050
China
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
Huai'an, 223300
China
Huizhou Central People's Hospital
Huizhou,
China
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
Tianjin, 300020
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, 214023
China
Affiliated Hospital of Jiangsu University
Zhenjiang, 212001
China
University Hospital Center Zagreb
Zagreb, 10000
Croatia
Fakultni Nemocnice Ostrava
Ostrava, 708 52
Czechia
Fakultni nemocnice Kralovske Vinohrady
Prague, 100 34
Czechia
CHU d'Amiens-Picardie - Hopital SUD
Amiens, 80054
France
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
Créteil, 94010
France
Centre Hospitalier Universitaire Dijon Bourgogne Medecine Interne et Immunologie Clinique
Dijon, 21079
France
University Hospital Carl Gustav Carus
Dresden, 01307
Germany
Universitaetsklinikum Essen (AoR)
Essen, 45147
Germany
Semmelweis University-Internal Medicine and Haematology
Budapest, 1088
Hungary
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
Győr, 9024
Hungary
Mater Misericordiae University Hospital
Dublin, D07 R2WY
Ireland
St James's Hospital - Cancer Clinical Trials Office
Dublin, D08 NHY1
Ireland
Azienda ULSS 7 Pedemontana
Bassano del Grappa, 36061
Italy
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
Florence, 50134
Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
Italy
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
Milan, 20122
Italy
ASST Grande Ospedale Metropolitano Niguarda
Milan, 20162
Italy
AO Maggiore Della Carita
Novara, 28100
Italy
U.O.C. Ematologia Ospedale Santa Maria delle Croci
Ravenna, 48121
Italy
Arcispedale Santa Maria Nuova (ASMN) Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
Reggio Emilia, 42123
Italy
A.O.U. Citta della Salute e della Scienza di Torino
Torino, 10126
Italy
AO Ordine Mauriziano di Torino
Torino, 10128
Italy
Azienda Sanitaria Universitaria Integrata
Trieste, 34125
Italy
ASST Sette Laghi Ospedale di circolo e Fondazione Macchi
Varese, 21100
Italy
Szpital Uniwersytecki nr 2 im. Dr Jana Biziela w Bydgoszczy
Bydgoszcz, 85-168
Poland
Pratia Onkologia Katowice
Katowice, 40-519
Poland
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
Lodz, 93-513
Poland
NZOZ Neuromed M. i M. Nastaj Sp.P.
Lublin, 20-064
Poland
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie Centrum Innowacyjnych Terapii
Lublin, 20-090
Poland
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
Nowy Sącz, 33-300
Poland
Wojewodzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
Torun, 87-100
Poland
Unidade Local de Saude de Braga
Braga, 4710
Portugal
Unidade Local de Saude Gaia e Espinho, E.P.E.
Vila Nova de Gaia, 4434-502
Portugal
Spitalul Clinic Coltea, Clinica de Hematologie
Bucharest, 030171
Romania
Spitalul Clinic Colentina
Bucharest, 20125
Romania
Spitalul Clinic Judetean de Urgenta Sibiu (SCJS) (Clinical County Hospital Sibiu)
Sibiu, 550245
Romania
Spitalul Clinic Judetean de Urgenta Targu-Mures
Târgu Mureş, 540136
Romania
Clinical Center of Serbia
Belgrade, 11000
Serbia
University Clinical Centre of Kragujevac
Kragujevac, 34000
Serbia
Clinical Center of Nis
Niš, 18000
Serbia
University Clinical Hospital Center Zemun
Zemun, 11080
Serbia
General Hospital Djordje Joanovic
Zrenjanin, 23101
Serbia
Complejo Hospitalario Universitario A Coruna
A Coruña, 15006
Spain
Instituto Catalan de Oncologia - Hospital Duran i Reynals
L'Hospitalet de Llobregat, 08908
Spain
Hospital Universitario Ramon y Cajal
Madrid, 28034
Spain
Hospital General Universitario Morales Meseguer
Murcia, 30008
Spain
University Hospital Quironsalud Madrid
Pozuelo de Alarcón, 28223
Spain
Hospital Clinico Universitario - University of Valencia
Valencia, 46010
Spain
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
Birmingham, B15 2GW
United Kingdom
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
Bradford, BD9 6RJ
United Kingdom
University Hospitals Coventry and Warwickshire NHS Trust
Coventry, CV2 2DX
United Kingdom
Glasgow Royal Infirmary - North Glasgow University Hospital Division
Glasgow, G4 0ET
United Kingdom
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
Leicester, LE1 5WW
United Kingdom
Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust
London, E1 2ES
United Kingdom
Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust
London, W12 0HS
United Kingdom
Royal Cornwall Hospital (RCH)
Truro, TR1 3LJ
United Kingdom