Efgartigimod IV: Intravenous infusion of efgartigimod
Placebo IV: Intravenous infusion of placebo
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
| Facility | City | Region | Status |
|---|---|---|---|
| Mayo Clinic Hospital Scottsdale | Phoenix | Arizona | Recruiting |
| University of Southern California Norris Comprehensive Cancer Center | Los Angeles | California | Recruiting |
| Sharp Memorial Hospital | Oceanside | California | Recruiting |
| University of Colorado Hospital | Aurora | Colorado | Recruiting |
| Yale University School of Medicine | New Haven | Connecticut | Recruiting |
| Georgetown University Hospital | Washington D.C. | District of Columbia | Recruiting |
| The University of Chicago Medicine | Chicago | Illinois | Recruiting |
| The University of Iowa Hospitals & Clinics | Iowa City | Iowa | Recruiting |
| Tulane University | New Orleans | Louisiana | Recruiting |
| Henry Ford Health | Detroit | Michigan | Recruiting |
| University of Minnesota | Minneapolis | Minnesota | Recruiting |
| Regional Cancer Care Associates, LLC (RCCA) | Little Silver | New Jersey | Recruiting |
| Clinical Research Alliance Inc. | Westbury | New York | Terminated |
| Duke University Medical Center | Durham | North Carolina | Recruiting |
| Brody School of Medicine at East Carolina University | Greenville | North Carolina | Recruiting |
| University Hospitals Cleveland Medical Center | Cleveland | Ohio | Recruiting |
| Ohio State University Hospital East | Columbus | Ohio | Recruiting |
| INTEGRIS Cancer Institute of Oklahoma | Oklahoma City | Oklahoma | Recruiting |
| Allgemeines Krankenhaus der Stadt Linz | Linz | Austria | Recruiting |
| Ordensklinikum Linz GmbH Elisabethinen | Linz | Austria | Recruiting |
| Klinikum Kreuzschwestern Wels | Wels | Austria | Recruiting |
| Acibadem City clinic Tokuda hospital | Sofia | Bulgaria | Recruiting |
| UMHAT Aleksandrovska | Sofia | Bulgaria | Recruiting |
| University Multi-Profile Hospital for Active Treatment (UMHAT) St. Ivan Rilski | Sofia | Bulgaria | Recruiting |
| National Specialized Hospital for Active Treatment of Hematology Diseases | Sofia | Bulgaria | Recruiting |
| UMHAT SofiaMed | Sofia | Bulgaria | Recruiting |
| University Hospital Prof. Dr. Stoyan Kirkovich AD | Stara Zagora | Bulgaria | Recruiting |
| Beijing YouYi Hospital-Beijing Friendship Hospital Capital Medical University | Beijing | China | Recruiting |
| Peking University Third Hospital | Beijing | China | Recruiting |
| The First Affiliated Hospital Of Bengbu Medical College | Bengbu | China | Recruiting |
| The Affiliated Hospital of Chengde Medical University | Chengde | China | Recruiting |
| The Affiliated Hospital of Inner Mongolia Medical University | Hohhot | China | Recruiting |
| The Affiliated Huaian No.1 People's Hospital of Nanjing Medical University | Huai'an | China | Recruiting |
| Huizhou Central People's Hospital | Huizhou | China | Recruiting |
| Institute of Hematology & Blood Diseases Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College | Tianjin | China | Recruiting |
| Union Hospital Tongji Medical College of Huazhong University of Science and Technology (HUST) | Wuhan | China | Recruiting |
| Wuxi People's Hospital (Wuxi No.1 People's Hospital) | Wuxi | China | Recruiting |
| Affiliated Hospital of Jiangsu University | Zhenjiang | China | Recruiting |
| University Hospital Center Zagreb | Zagreb | Croatia | Recruiting |
| Fakultni Nemocnice Ostrava | Ostrava | Czechia | Recruiting |
+ 54 more sites — see the full list on the official registry below.
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT06544499 on ClinicalTrials.gov ↗ ← All trials in the USA