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Recruiting Phase 3 Interventional

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

ClinicalTrials.gov ID: NCT06544499

Public ClinicalTrials.gov record NCT06544499. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.

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ClinicalTrials.gov public records Last synced Sep 2, 2026, 6:47 PM EDT

Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.

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

Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

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

Study identification

NCT ID
NCT06544499
Recruitment status
Recruiting
Study type
Interventional
Phase
Phase 3
Lead sponsor
argenx
Industry
Enrollment
69 participants

Conditions and interventions

Interventions

Biological · Other

Eligibility (public fields only)

Age range
18 Years and older
Sex
All
Healthy volunteers
Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date
Oct 17, 2024
Primary completion
May 31, 2028
Completion
May 31, 2028
Last update posted
Apr 30, 2026

2024 – 2028

United States locations

U.S. sites
18
U.S. states
15
U.S. cities
18
Facility City State ZIP Site status
Mayo Clinic Hospital Scottsdale Phoenix Arizona 85054 Recruiting
University of Southern California Norris Comprehensive Cancer Center Los Angeles California 90033 Recruiting
Sharp Memorial Hospital Oceanside California 92056 Recruiting
University of Colorado Hospital Aurora Colorado 80045 Recruiting
Yale University School of Medicine New Haven Connecticut 06510 Recruiting
Georgetown University Hospital Washington D.C. District of Columbia 20007 Recruiting
The University of Chicago Medicine Chicago Illinois 60637 Recruiting
The University of Iowa Hospitals & Clinics Iowa City Iowa 52242 Recruiting
Tulane University New Orleans Louisiana 70112 Recruiting
Henry Ford Health Detroit Michigan 48202 Recruiting
University of Minnesota Minneapolis Minnesota 55422 Recruiting
Regional Cancer Care Associates, LLC (RCCA) Little Silver New Jersey 07739 Recruiting
Clinical Research Alliance Inc. Westbury New York 11590 Terminated
Duke University Medical Center Durham North Carolina 27710 Recruiting
Brody School of Medicine at East Carolina University Greenville North Carolina 27834 Recruiting
University Hospitals Cleveland Medical Center Cleveland Ohio 44106 Recruiting
Ohio State University Hospital East Columbus Ohio 43203 Recruiting
INTEGRIS Cancer Institute of Oklahoma Oklahoma City Oklahoma 73109 Recruiting

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

Non-U.S. locations

This page focuses on the U.S. directory. The official record also lists 75 non-U.S. sites.

About this trial record page

What this page shows
Public field values for ClinicalTrials.gov record NCT06544499, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do
No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from
Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh
Last update posted Apr 30, 2026 · Synced Sep 2, 2026

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Open the official record

The complete protocol, eligibility criteria, and contact information for NCT06544499 live on ClinicalTrials.gov.

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