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

Status: Recruiting
Location: See all (83) locations...
Intervention Type: Other, Biological
Study Type: Interventional
Study Phase: Phase 3
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• Is at least 18 years of age and the local legal age of consent for clinical studies when signing the informed consent form (ICF).

• Has documented baseline mean platelet count of \<30 x 10\^9/L before randomization

• Has a documented duration of primary immune thrombocytopenia (ITP) of more than 12 months on the date of informed consent form (ICF) signature.

• Has documented prior ITP treatment with at least 1 of the following treatments: corticosteroids, intravenous immunoglobulin (IVIg), anti-D immunoglobulin, thrombopoietin receptor agonist (TPO-RAs), or rituximab.

• Has documented insufficient response to a prior ITP treatment (the specific criteria can be found in the protocol).

• Has documented prior response defined as 1 platelet count of ≥50 × 109/L to at least 1 of the following ITP treatments in the 3 years before the date of ICF signature: prednisone, dexamethasone, other or nonspecified corticosteroids, IVIg, or anti-D immunoglobulin

Locations
United States
California
University of Southern California Norris Comprehensive Cancer Center
RECRUITING
Los Angeles
Sharp Memorial Hospital
RECRUITING
Oceanside
Connecticut
Yale University School of Medicine
RECRUITING
New Haven
Washington, D.c.
Georgetown University Hospital
RECRUITING
Washington D.c.
Iowa
The University of Iowa Hospitals & Clinics
RECRUITING
Iowa City
Illinois
The University of Chicago Medicine
RECRUITING
Chicago
Michigan
Henry Ford Health
RECRUITING
Detroit
North Carolina
Duke University Medical Center
RECRUITING
Durham
New Jersey
Regional Cancer Care Associates, LLC (RCCA)
RECRUITING
Little Silver
New York
Clinical Research Alliance Inc.
TERMINATED
Westbury
Ohio
Ohio State University Hospital East
RECRUITING
Columbus
Oklahoma
INTEGRIS Cancer Institute of Oklahoma
RECRUITING
Oklahoma City
Other Locations
Austria
Allgemeines Krankenhaus der Stadt Linz
RECRUITING
Linz
Ordensklinikum Linz GmbH Elisabethinen
RECRUITING
Linz
Klinikum Kreuzschwestern Wels
RECRUITING
Wels
Bulgaria
Acibadem City clinic Tokuda hospital
RECRUITING
Sofia
National Specialized Hospital for Active Treatment of Hematology Diseases
RECRUITING
Sofia
UMHAT Aleksandrovska
RECRUITING
Sofia
UMHAT SofiaMed
RECRUITING
Sofia
University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski
RECRUITING
Sofia
University Hospital Prof. Dr. Stoyan Kirkovich AD
RECRUITING
Stara Zagora
China
Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University
RECRUITING
Beijing
Peking University Third Hospital
RECRUITING
Beijing
The First Affiliated Hospital Of Bengbu Medical College
RECRUITING
Bengbu
The Affiliated Hospital of Chengde Medical University
RECRUITING
Chengde
The Affiliated Hospital of Inner Mongolia Medical University
RECRUITING
Hohhot
The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University
RECRUITING
Huai'an
Huizhou Central People's Hospital
RECRUITING
Huizhou
Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College
RECRUITING
Tianjin
Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST)
RECRUITING
Wuhan
Wuxi People's Hospital (Wuxi No.1 People's Hospital)
RECRUITING
Wuxi
Affiliated Hospital of Jiangsu University
RECRUITING
Zhenjiang
Croatia
University Hospital Center Zagreb
RECRUITING
Zagreb
France
CHU d'Amiens-Picardie - Hopital SUD
RECRUITING
Amiens
Centre Hospitalier Universitaire (CHU) - Hopital Henri Mondor
RECRUITING
Créteil
Centre Hospitalier Universitaire Dijon Bourgogne Medecine Interne et Immunologie Clinique
RECRUITING
Dijon
Germany
University Hospital Carl Gustav Carus
RECRUITING
Dresden
Universitaetsklinikum Essen (AoR)
RECRUITING
Essen
Hungary
Semmelweis University-Internal Medicine and Haematology
RECRUITING
Budapest
Gyor-Moson-Sopron Varmegyei Petz Aladar Egyetemi Oktato Korhaz
RECRUITING
Győr
Ireland
Mater Misericordiae University Hospital
RECRUITING
Dublin
St James's Hospital - Cancer Clinical Trials Office
RECRUITING
Dublin
Italy
Azienda ULSS 7 Pedemontana
RECRUITING
Bassano Del Grappa
Universita Degli Studi Di Firenze - Azienda Ospedaliero-Universitaria Careggi (AOUC)
RECRUITING
Florence
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
RECRUITING
Milan
Fondazione IRCCS Ca' Granda - Ospedale Maggiore Policlinico
RECRUITING
Milan
AO Maggiore Della Carita
RECRUITING
Novara
U.O.C. Ematologia Ospedale Santa Maria delle Croci
RECRUITING
Ravenna
Arcispedale Santa Maria Nuova (ASMN) Istituto di Ricovero e Cura a Carattere Scientifico (IRCCS)
RECRUITING
Reggio Emilia
A.O.U. Citta della Salute e della Scienza di Torino
RECRUITING
Torino
AO Ordine Mauriziano di Torino
RECRUITING
Torino
Azienda Sanitaria Universitaria Integrata
RECRUITING
Trieste
ASST Sette Laghi Ospedale di circolo e Fondazione Macchi
RECRUITING
Varese
Poland
Pratia Onkologia Katowice
RECRUITING
Katowice
Wojewodzkie Wielospecjalistyczne Centrum Onkologii i Traumatologii im. M. Kopernika w Lodzi
RECRUITING
Lodz
NZOZ Neuromed M. i M. Nastaj Sp.P.
RECRUITING
Lublin
Uniwersytecki Szpital Kliniczny Nr 4 w Lublinie Centrum Innowacyjnych Terapii
RECRUITING
Lublin
Szpital Specjalistyczny im. Jedrzeja Sniadeckiego w Nowym Saczu
RECRUITING
Nowy Sącz
Wojewodzki Szpital Zespolony im. Ludwika Rydygiera w Toruniu
RECRUITING
Torun
Portugal
Unidade Local de Saude de Braga
RECRUITING
Braga
Romania
Spitalul Clinic Colentina
RECRUITING
Bucharest
Spitalul Clinic Coltea, Clinica de Hematologie
RECRUITING
Bucharest
Spitalul Clinic Judetean de Urgenta Sibiu (SCJS) (Clinical County Hospital Sibiu)
RECRUITING
Sibiu
Spitalul Clinic Judetean de Urgenta Targu-Mures
RECRUITING
Târgu Mureş
Serbia
Clinical Center of Serbia
RECRUITING
Belgrade
University Clinical Centre of Kragujevac
RECRUITING
Kragujevac
Clinical Center of Nis
RECRUITING
Niš
University Clinical Hospital Center Zemun
RECRUITING
Zemun
General Hospital Djordje Joanovic
RECRUITING
Zrenjanin
Spain
Complejo Hospitalario Universitario A Coruna
RECRUITING
A Coruña
Instituto Catalan de Oncologia - Hospital Duran i Reynals
RECRUITING
L'hospitalet De Llobregat
Hospital Universitario Ramon y Cajal
RECRUITING
Madrid
Hospital General Universitario Morales Meseguer
RECRUITING
Murcia
University Hospital Quironsalud Madrid
RECRUITING
Pozuelo De Alarcón
Hospital Clinico Universitario - University of Valencia
RECRUITING
Valencia
United Kingdom
Queen Elizabeth Hospital Birmingham - University Hospitals Birmingham NHS Foundation Trust
RECRUITING
Birmingham
Bradford Royal Infirmary - Bradford Teaching Hospitals NHS Foundation
RECRUITING
Bradford
University Hospitals Coventry and Warwickshire NHS Trust
RECRUITING
Coventry
Glasgow Royal Infirmary - North Glasgow University Hospital Division
RECRUITING
Glasgow
University Hospitals of Leicester NHS Trust-Leicester Royal Infirmary
RECRUITING
Leicester
Barts and the London Pathology & Pharmacy Building - Barts Health NHS Trust
RECRUITING
London
Hammersmith Hospital, Imperial College School Of Medicine - Imperial College Healthcare NHS Trust
RECRUITING
London
Royal Cornwall Hospital (RCH)
RECRUITING
Truro
Contact Information
Primary
Sabine Coppieters, MD
Clinicaltrials@argenx.com
857-350-4834
Time Frame
Start Date: 2024-10-18
Estimated Completion Date: 2028-06
Participants
Target number of participants: 69
Treatments
Experimental: Efgartigimod IV
Participants receiving efgartigimod IV during the double-blinded treatment period and the open-label treatment period(s)
Experimental: Placebo IV
Participants receiving placebo IV during the double-blinded treatment period and receiving efgartigimod IV during the open-label treatment period(s)
Sponsors
Leads: argenx

This content was sourced from clinicaltrials.gov

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