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 May 5, 2026, 3:44 AM 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

Study identification

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

Conditions and interventions

Conditions

Primary Immune Thrombocytopenia (ITP)

Interventions

Efgartigimod IV Biological
Placebo IV Other

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 May 5, 2026

Open the official record

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

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