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Withdrawn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

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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