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A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia
NCT06544499 · View on ClinicalTrials.gov ↗
Study 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. More information can be found here: https://clinicaltrials.argenx.com/advancenext
Conditions Studied
Interventions
- BIOLOGICAL Efgartigimod IV
- OTHER Placebo IV
Study Locations (20)
California
- University of Southern California Norris Comprehensive Cancer Center — Los Angeles
- Sharp Memorial Hospital — Oceanside
North Carolina
- Duke University Medical Center — Durham
- Brody School of Medicine at East Carolina University — Greenville
Ohio
- University Hospitals Cleveland Medical Center — Cleveland
- Ohio State University Hospital East — Columbus
Other
- Allgemeines Krankenhaus der Stadt Linz — Linz
- Ordensklinikum Linz GmbH Elisabethinen — Linz
Arizona
- Mayo Clinic Hospital Scottsdale — Phoenix
Colorado
- University of Colorado Hospital — Aurora
Connecticut
- Yale University School of Medicine — New Haven
District of Columbia
- Georgetown University Hospital — Washington D.C.
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 69 participants |
| Start Date | 2024-10-18 |
| Est. Completion | 2028-06 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06544499
The ClinicalTrials.gov registry entry for NCT06544499 describes a study currently listed as recruiting. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 69 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is argenx, which has 96 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Primary Immune Thrombocytopenia (ITP) appearing as the primary indexed condition, and to 2 interventions — of which Efgartigimod IV is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT06544499 reports 20 study locations spanning 16 distinct geographic areas — top geographies include California, North Carolina, Ohio. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT06544499 about?
NCT06544499 is a clinical study titled "A Study to Assess the Efficacy and Safety of Efgartigimod IV in Adult Participants With Primary Immune Thrombocytopenia". 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 I...
What is the current status of trial NCT06544499?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 69 participants. The study started on 2024-10-18. Estimated completion is 2028-06.
What conditions does trial NCT06544499 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia (ITP). These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT06544499?
The interventions under investigation include: Efgartigimod IV (BIOLOGICAL), Placebo IV (OTHER). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT06544499?
This trial is sponsored by argenx, which has 96 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT06544499 being conducted?
This trial has 20 study locations across Arizona, California, Colorado, Connecticut, District of Columbia. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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