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A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).
NCT04188379 · View on ClinicalTrials.gov ↗
Study Summary
This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
Conditions Studied
Interventions
- OTHER Placebo
- BIOLOGICAL efgartigimod
Study Locations (20)
Other
- Investigator Site 0430004 — Linz
- Investigator Site 0430002 — Vienna
- Investigator Site 0430003 — Vienna
- Investigator Site 0320012 — Brasschaat
- Investigator Site 0320011 — Bruges
- Investigator Site 0320015 — Leuven
- Investigator Site 0320014 — Turnhout
- Investigator Site 0320020 — Verviers
- Investigator site 0320002 — Yvoir
- Investigator Site 3590001 — Pleven
- Investigator Site 3590002 — Sofia
Florida
- Investigator Site 0010034 — Jacksonville
- Investigator site 0010037 — Ocala
Ohio
- Investigator Site 0010049 — Cleveland
- Investigator Site 0010040 — Columbus
Arizona
- Investigator Site 0010038 — Tucson
District of Columbia
- Investigator Site 0010045 — Washington D.C.
Iowa
- Investigator Site 0010042 — Iowa City
North Carolina
- Investigator Site 0010046 — Greenville
Pennsylvania
- Investigator Site 0010041 — Philadelphia
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 131 participants |
| Start Date | 2019-12-16 |
| Est. Completion | 2022-02-03 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04188379
The ClinicalTrials.gov registry entry for NCT04188379 describes a study currently listed as completed. 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 131 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 appearing as the primary indexed condition, and to 2 interventions — of which Placebo 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: NCT04188379 reports 20 study locations spanning 8 distinct geographic areas — top geographies include Other, Florida, 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 NCT04188379 about?
NCT04188379 is a clinical study titled "A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).". This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in participants with primary ITP.
What is the current status of trial NCT04188379?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 131 participants. The study started on 2019-12-16. Estimated completion is 2022-02-03.
What conditions does trial NCT04188379 study?
This clinical trial studies the following conditions: Primary Immune Thrombocytopenia. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04188379?
The interventions under investigation include: Placebo (OTHER), efgartigimod (BIOLOGICAL). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04188379?
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 NCT04188379 being conducted?
This trial has 20 study locations across Arizona, District of Columbia, Florida, Iowa, North Carolina. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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