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Study identifier: NCT06544499 Synced from ClinicalTrials.gov · July 29, 2026
● Recruiting

A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia

Condition: Primary Immune Thrombocytopenia (ITP)  ·  Sponsor: argenx

PhasePhase 3
Planned participants69
Who can joinAll sexes, 18 Years to no upper limit
Healthy volunteersNo

About this study

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

This description comes directly from the study's public registry record.

Talk to the study team

Sabine Coppieters, MD  ·  857-350-4834  ·  Clinicaltrials@argenx.com

Always discuss trial participation with your own doctor first.

Locations (94)

Mayo Clinic Hospital ScottsdalePhoenix, Arizona, United StatesRecruiting
University of Southern California Norris Comprehensive Cancer CenterLos Angeles, California, United StatesRecruiting
Sharp Memorial HospitalOceanside, California, United StatesRecruiting
University of Colorado HospitalAurora, Colorado, United StatesRecruiting
Yale University School of MedicineNew Haven, Connecticut, United StatesRecruiting
Georgetown University HospitalWashington D.C., District of Columbia, United StatesRecruiting
The University of Chicago MedicineChicago, Illinois, United StatesRecruiting
The University of Iowa Hospitals & ClinicsIowa City, Iowa, United StatesRecruiting
Tulane UniversityNew Orleans, Louisiana, United StatesRecruiting
Henry Ford HealthDetroit, Michigan, United StatesRecruiting
University of MinnesotaMinneapolis, Minnesota, United StatesRecruiting
Regional Cancer Care Associates, LLC (RCCA)Little Silver, New Jersey, United StatesRecruiting

+ 82 more locations — full list on the registry record.

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Source record: clinicaltrials.gov/study/NCT06544499