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A Phase 3 Study to Evaluate the Safety and Efficacy of Efgartigimod PH20 Subcutaneous in Adult Patients With Primary Immune Thrombocytopenia

NCT04812925 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 173

Last updated 2026-01-12

No results posted yet for this study

Summary

A Phase 3 study to evaluate the safety and efficacy of efgartigimod PH20 subcutaneous in adult patients with primary immune thrombocytopenia

Conditions

  • Primary Immune Thrombocytopenia

Interventions

BIOLOGICAL

efgartigimod PH20 SC

Subcutaneous injection with efgartigimod PH20 SC

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-11-17
Primary Completion
2026-10-01
Completion
2026-10-01
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Australia
  • Bulgaria
  • Chile
  • China
  • Georgia
  • Greece
  • Ireland
  • Italy
  • Japan
  • Jordan
  • Mexico
  • New Zealand
  • Norway
  • Poland
  • Portugal
  • Romania
  • Russia
  • South Africa
  • South Korea
  • Thailand
  • Tunisia
  • Turkey (Türkiye)
  • 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 NCT04812925 on ClinicalTrials.gov