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

Part of paid clinical trials in Tucson, Arizona.

Sponsor
argenx
Study ID
NCT04188379
Phase
PHASE3
Status
Completed

Conditions

  • Primary Immune Thrombocytopenia

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 participants with primary ITP.

Key Dates

Start date
Dec 16, 2019
Status verified
Feb 2025
Primary completion
Feb 3, 2022
Completion
Feb 3, 2022

Study Design

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

Arms

  • Experimental: efgartigimod
    Patient receiving efgartigimod
  • Placebo Comparator: Placebo
    Patients receiving placebo

Primary Outcome Measure

Percentage of Participants With Chronic ITP With a Sustained Platelet Count Response Defined as Achieving Platelet Counts of at Least 50×10^9/L for at Least 4 of the 6 Visits Between Week 19 and 24 of the Trial. [ Time Frame: From Week 19 up to Week 24 ]

Locations (9)

FacilityCityStateZIPSite coordinators
Investigator Site 0010038TucsonArizona85711-
Investigator Site 0010045Washington D.C.District of Columbia20007-
Investigator Site 0010034JacksonvilleFlorida32204-
Investigator site 0010037OcalaFlorida34474-
Investigator Site 0010042Iowa CityIowa52242-
Investigator Site 0010046GreenvilleNorth Carolina27834-
Investigator Site 0010049ClevelandOhio44106-
Investigator Site 0010040ColumbusOhio44106-
Investigator Site 0010041PhiladelphiaPennsylvania19104-

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