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

Sponsor
argenx
Study ID
NCT04274452
Phase
PHASE3
Status
Withdrawn

Conditions

  • Primary Immune Thrombocytopenia (ITP)

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • efgartigimod — BIOLOGICAL
    Intravenous infusion of efgartigimod
  • Placebo — OTHER
    Intravenous infusion of placebo

Study Details

This is a randomized, double-blind placebo-controlled multicenter phase 3 trial to evaluate the efficacy and safety of ARGX-113 in patients with primary ITP.

Key Dates

First listed
Feb 18, 2020
Start date
Jun 29, 2020
Status verified
Sep 2020
Primary completion
Sep 1, 2021
Completion
Sep 1, 2021

Study Design

Enrollment
0 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: efgartigimod
    Patients receiving an intravenous infusion of efgartigimod
  • Placebo Comparator: placebo
    Patients receiving an intravenous infusion of placebo

Primary Outcome Measure

Number of cumulative weeks over the planned 24 week treatment period with platelet counts of ≥50×10^9/L in patients with chronic ITP. [ Time Frame: Up to 24 weeks ]

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