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

NCT04188379 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 131

Last updated 2025-03-13

Study results available
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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

  • Primary Immune Thrombocytopenia

Interventions

BIOLOGICAL

efgartigimod

Intravenous infusion of efgartigimod

OTHER

Placebo

Intravenous infusion of placebo

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-12-16
Primary Completion
2022-02-03
Completion
2022-02-03
FDA Drug
Yes

Countries

  • United States
  • Austria
  • Belgium
  • Bulgaria
  • Czechia
  • France
  • Georgia
  • Germany
  • Hungary
  • Italy
  • Japan
  • Netherlands
  • Poland
  • Russia
  • Spain
  • Turkey (Türkiye)
  • Ukraine
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04188379 on ClinicalTrials.gov