Myasthenia Gravis Inebilizumab Trial

Part of paid clinical trials in Orange, California.

Sponsor
Amgen
Study ID
NCT04524273
Phase
PHASE3
Status
Active Not Recruiting

Conditions

  • Myasthenia Gravis

Eligibility Criteria

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

Interventions

  • inebilizumab — DRUG
    Participants will receive IV inebilizumab
  • IV Placebo — DRUG
    Participants will receive IV placebo matched to inebilizumab

Study Details

Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.

Key Dates

Start date
Oct 15, 2020
Status verified
May 2026
Primary completion
May 28, 2024
Completion
Jun 7, 2029

Study Design

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

Arms

  • Experimental: Inebilizumab, (AChR-Ab+) MG
    Participants will receive inebilizumab administered intravenously (IV) on Days 1, 15, and 183 of the RCP. Participants who elect to enter the open label phase (OLP) will receive inebilizumab administered IV on OLP Days 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
  • Placebo Comparator: Placebo, (AChR-Ab+) MG
    Participants will receive placebo administered IV on Days 1, 15, and 183 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.
  • Experimental: Inebilizumab, (MuSK-Ab+) MG
    Participants will receive inebilizumab administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Day 1, IV placebo on OLP Day 15 (to avoid potential unblinding), and inebilizumab IV on OLP Days 183, 365, 547, 729, and 911.
  • Placebo Comparator: Placebo, (MuSK-Ab+) MG
    Participants will receive placebo administered IV on Days 1 and 15 of the RCP. Participants who elect to enter the OLP will receive inebilizumab administered IV on OLP Days 1,15, 183, 365, 547, 729, and 911.

Primary Outcome Measure

Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population [ Time Frame: Baseline and Week 26 ]

Locations (16)

FacilityCityStateZIPSite coordinators
Viela Bio Investigative Site - 1015OrangeCalifornia92868-
Viela Bio Investigative Site - 1002New HavenConnecticut06519-
Viela Bio Investigative Center - 1024Washington D.C.District of Columbia20010-
Viela Bio Investigative Site - 1005TampaFlorida33612-
Viela Bio Investigative Site - 1012Kansas CityKansas66160-
Viela Bio Investigative Site - 1018CharlotteNorth Carolina28203-
Viela Bio Investigative Site - 1025CantonOhio44718-
Viela Bio Investigative Site - 1001CincinnatiOhio45219-
Viela Bio Investigative Site - 1009ColumbusOhio43210-
Viela Bio Investigative Site - 1008PittsburghPennsylvania15212-
Viela Bio Investigative Site - 1019AustinTexas78759-
Viela Bio Investigative Site - 1003HoustonTexas77030-
Viela Bio Investigative Site - 1014San AntonioTexas78229-
Viela Bio Investigative Site - 1017Salt Lake CityUtah84132-
Viela Bio Investigative Site - 1004BurlingtonVermont05401-
Viela Bio Investigative Site - 1006RichmondVirginia23298-

Find similar trials in Orange, CA

By research site
Viela Bio Investigative Site - 1015· Orange, CAViela Bio Investigative Site - 1002· New Haven, CTViela Bio Investigative Center - 1024· Washington D.C., DCViela Bio Investigative Site - 1005· Tampa, FLViela Bio Investigative Site - 1012· Kansas City, KSViela Bio Investigative Site - 1018· Charlotte, NC

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