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

Part of paid clinical trials in Springdale, Arkansas.

Sponsor
argenx
Study ID
NCT04687072
Phase
PHASE3
Status
Completed

Conditions

  • Primary Immune Thrombocytopenia

Eligibility Criteria

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

Interventions

  • Efgartigimod PH20 SC — BIOLOGICAL
    Subcutaneous injection with efgartigimod PH20 SC
  • Placebo PH20 SC — OTHER
    Subcutaneous injection with placebo PH20 SC

Study Details

This is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group trial to evaluate the efficacy, safety, and effect on QoL/PRO of efgartigimod PH20 SC treatment in adult patients with primary ITP.

Key Dates

Start date
Dec 16, 2020
Status verified
Oct 2024
Primary completion
Oct 9, 2023
Completion
Oct 9, 2023

Study Design

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

Arms

  • Experimental: Efgartigimod PH20 SC
    Patients receiving efgartigimod PH20 SC treatment
  • Placebo Comparator: Placebo PH20 SC
    Patients receiving placebo PH20 SC treatment

Primary Outcome Measure

Percentage of Participants With Chronic Immune Thrombocytopenia (ITP) With a Sustained Platelet Count Response Between Weeks 19 and 24 [ Time Frame: Up to 6 weeks (between Weeks 19 and 24) ]

Locations (14)

FacilityCityStateZIPSite coordinators
Investigator Site 0010116SpringdaleArkansas72758-
Investigator site 0010036Los AngelesCalifornia90033-
Investigator Site 0010045Washington D.C.District of Columbia20007-
Investigator Site 0010104WestonFlorida33331-
Investigator site 0010112ChicagoIllinois60612-
Investigator site 0010193ChicagoIllinois60637-
Investigator Site 0010079LisleIllinois60187-
Investigator Site 0010062Fort WayneIndiana46804-
Investigator site 0010042Iowa CityIowa52242-
Investigator Site 0010083DetroitMichigan48202-
Investigator Site 0010102MinneapolisMinnesota55455-
Investigator site 0010040ColumbusOhio43210-
Investigator Site 0010095Oklahoma CityOklahoma73142-
Investigator Site 0010115PittsburghPennsylvania15222-

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