Evaluating the Pharmacodynamic Noninferiority of Efgartigimod PH20 SC Administered Subcutaneously as Compared to Efgartigimod Administered Intravenously in Patients With Generalized Myasthenia Gravis

Part of paid clinical trials in Carlsbad, California.

Sponsor
argenx
Study ID
NCT04735432
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • efgartigimod PH20 SC — BIOLOGICAL
    Subcutaneous injection with efgartigimod PH20 SC
  • efgartigimod IV — BIOLOGICAL
    Intravenous infusion of efgartigimod

Study Details

The purpose of this study is to investigate the Pharmacodynamics (PD), Pharmacokinetics (PK), safety, tolerability, immunogenicity, and clinical efficacy of efgartigimod coformulated with recombinant human hyaluronidase PH20 (rHuPH20) as compared to efgartigimod IV infused in patients with generalized myasthenia gravis (gMG). The study duration is approximately 12 weeks. After screening, patients will be randomized to receive either efgartigimod infusions or efgartigimod PH20 subcutaneously (SC)

Key Dates

Start date
Feb 5, 2021
Status verified
Jan 2023
Primary completion
Nov 2, 2021
Completion
Dec 13, 2021

Study Design

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

Arms

  • Experimental: efgartigimod PH20 SC
    Patients receiving efgartigimod PH20 subcutaneous (SC) treatment
  • Experimental: efgartigimod
    Patients receiving efgartigimod intravenous (IV) treatment

Primary Outcome Measure

Percent Change From Baseline in Total IgG Levels at Day 29 (mITT Analysis Set) [ Time Frame: From week 0 to week 4 ]

Locations (14)

FacilityCityStateZIPSite coordinators
Investigator site 2 - US0010032CarlsbadCalifornia92011-
Investigator Site 41 - US0010004OrangeCalifornia92868-
Investigator site 2 - US0010108Boca RatonFlorida33428-
Investigator site 1 - US0010110Port CharlotteFlorida33952-
Investigator Site 27 - US0010006TampaFlorida41076-
Investigator Site 47 - US0010113AugustaGeorgia30912-
Investigator Site 42 - US0010015Kansas CityKansas66205-
Investigator Site 11 - US0010111AmherstNew York14226-
Investigator Site 40 - US0010003Chapel HillNorth Carolina27514-
Investigator Site 38 - US0010077DurhamNorth Carolina27710-
Investigator Site 43 - 0010019ClevelandOhio44195-
Investigator site 4 - US0010008CordovaTennessee38018-
Investigator Site 28 - US0010066AustinTexas78756-
Investigator Site 46 - US0010009Texas CityTexas78229-

Find similar trials in Carlsbad, CA

By research site
Investigator site 2 - US0010032· Carlsbad, CAInvestigator Site 41 - US0010004· Orange, CAInvestigator site 2 - US0010108· Boca Raton, FLInvestigator site 1 - US0010110· Port Charlotte, FLInvestigator Site 27 - US0010006· Tampa, FLInvestigator Site 47 - US0010113· Augusta, GA

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