An Efficacy and Safety Study of ARGX-113 in Patients With Myasthenia Gravis Who Have Generalized Muscle Weakness

Part of paid clinical trials in Phoenix, Arizona.

Sponsor
argenx
Study ID
NCT03669588
Phase
PHASE3
Status
Completed

Conditions

  • Generalized Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • ARGX-113 — BIOLOGICAL
    Intravenous administration of ARGX-113
  • Placebo — BIOLOGICAL
    Intravenous administration of placebo

Study Details

A randomized, double-blind, placebo controlled, multicenter Phase 3 trial to evaluate the efficacy, safety, tolerability, quality of life and impact on normal daily activities of ARGX-113 in patients with gMG.

Key Dates

Start date
Aug 22, 2018
Status verified
Mar 2021
Primary completion
Apr 6, 2020
Completion
Apr 6, 2020

Study Design

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

Arms

  • Experimental: ARGX-113
  • Placebo Comparator: Placebo

Primary Outcome Measure

Percentage of MG-ADL Responders During Cycle 1 (C1); Analyzed in the AChR-Ab Seropositive Population [ Time Frame: Baseline up to Day 63 (end of TC1) ]

Locations (25)

FacilityCityStateZIPSite coordinators
Investigator Site 29PhoenixArizona85018-
Investigator Site 66CarlsbadCalifornia92011-
Investigator Site 49Los AngelesCalifornia90095-
Investigator Site 5Los AngelesCalifornia90033-
Investigator Site 18OrangeCalifornia92868-
Investigator Site 40Palo AltoCalifornia94304-
Investigator Site 59San FranciscoCalifornia94115-
Investigator Site 58AuroraColorado80045-
Investigator Site 34JacksonvilleFlorida32209-
Investigator Site 4TampaFlorida33612-
Investigator Site 30SpringfieldIllinois62702-
Investigator Site 25Iowa CityIowa52242-
Investigator Site 21Kansas CityKansas66160-
Investigator Site 27BostonMassachusetts02115-
Investigator Site 48DetroitMichigan48201-
Investigator Site 53BuffaloNew York14202-
Investigator Site 3Chapel HillNorth Carolina27599-
Investigator Site 20ClevelandOhio44195-
Investigator Site 9PortlandOregon97239-
Investigator Site 17CharlestonSouth Carolina29425-
Investigator SiteCordovaTennessee38018-
Investigator Site 44HoustonTexas77030-
Investigator Site 6San AntonioTexas78229-
Investigator Site 2CharlottesvilleVirginia22908-
Investigator Site 16SeattleWashington98195-

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