Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.

NCT04188379 · ClinicalTrials.gov registry record · Phase 3

A Study to Assess the Efficacy and Safety of Efgartigimod in Adult Patients With Primary Immune Thrombocytopenia (ITP).

A Phase 3 study of Primary Immune Thrombocytopenia, sponsored by argenx.

Completed
Registry status
Phase 3
Development phase
131
Enrollment target
20
Study locations

NCT04188379 is a Phase 3 study of Primary Immune Thrombocytopenia that has completed, run by argenx. The registered enrollment target is 131 participants, above the 107-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (22% higher). The trial reports 20 study locations across 8 states.

View on ClinicalTrials.gov ↗

View your shortlist →

The verdict

NCT04188379, a Phase 3 study of Primary Immune Thrombocytopenia, has completed, sponsored by argenx.

COMPLETED
Registry status
Phase 3
Development phase
131 participants
Enrollment target
20
Study locations

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.

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

FieldValue
Enrollment Target 131 participants
Start Date 2019-12-16
Est. Completion 2022-02-03
Phase Phase 3

Sponsor

argenx

49 total trials

What the Registry Record Tells You About NCT04188379

The ClinicalTrials.gov registry entry for NCT04188379 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 131 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 107-participant average among 4 other Primary Immune Thrombocytopenia trials with a reported enrollment target (22% higher). The listed sponsor is argenx, which has 49 total studies on file at ClinicalTrials.gov.

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.

NCT04188379 reports 20 study locations spanning 8 distinct geographic areas - top geographies include Other, Florida, Ohio.

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.

What interventions are being tested in trial NCT04188379?

The interventions under investigation include: Placebo (OTHER), efgartigimod (BIOLOGICAL).

Who is sponsoring clinical trial NCT04188379?

This trial is sponsored by argenx, which has 49 total clinical trials registered on ClinicalTrials.gov.

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.

Similar trials for Primary Immune Thrombocytopenia

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.