Myasthenia Gravis Inebilizumab Trial

Running, not enrolling · Phase 3 · Has a placebo group

Conditions studied: Myasthenia Gravis

In brief

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

Key facts

Study ID

NCT04524273

Run by

Amgen

People needed

238

Starts

2020-10-15

Expected to finish

2029-06-07

Last updated by the study team

2026-05-15

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Diagnosis of MG with anti-AChR or anti-MuSK antibody.
• MGFA Clinical Classification Class II, III, or IV.
• MG-ADL score of 6 or greater at screening and at randomization with > 50% of this score attributed to non-ocular items.
• QMG score of 11 or greater.
• Participants must be on:
• Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or
• One allowed non-steroidal immunosuppressive therapy (IST), with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization, or
• Combination of (1) corticosteroids with no dose increase within 4 weeks prior to randomization and (2) one allowed non-steroidal IST with continuous use for at least 6 months prior to randomization and no dose increase within 4 months prior to randomization.
• Allowed ISTs, alone or in combination with corticosteroids, are azathioprine, mycophenolate mofetil, and mycophenolic acid.

You may not qualify if…

• Receipt of the following medications within the 4 weeks prior to Day 1:
• Cyclosporine (except eye drops)
• Tacrolimus (except topical)
• Methotrexate
• Current use of:
• Corticosteroids (Prednisone > 40 milligram (mg)/day or > 80 mg over a 2-day period (or equivalent dose of other corticosteroids).
• Acetylcholinesterase inhibitors (pyridostigmine) > 480 mg/day) or unstable dose in the 2 weeks prior to Day 1.
• Azathioprine > 3 mg/kilogram (kg)/day
• Mycophenolate mofetil > 3 grams/day or mycophenolic acid > 1440 mg/day
• Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Where it is running

• Viela Bio Investigative Site - 1002 — New Haven, Connecticut, United States
• Viela Bio Investigative Center - 1024 — Washington D.C., District of Columbia, United States
• Viela Bio Investigative Site - 1005 — Tampa, Florida, United States
• Viela Bio Investigative Site - 1012 — Kansas City, Kansas, United States
• Viela Bio Investigative Site - 1018 — Charlotte, North Carolina, United States
• Viela Bio Investigative Site - 1025 — Canton, Ohio, United States
• Viela Bio Investigative Site - 1001 — Cincinnati, Ohio, United States
• Viela Bio Investigative Site - 1009 — Columbus, Ohio, United States
• Viela Bio Investigative Site - 1008 — Pittsburgh, Pennsylvania, United States
• Viela Bio Investigative Site - 1019 — Austin, Texas, United States
• Viela Bio Investigative Site - 1003 — Houston, Texas, United States
• Viela Bio Investigative Site - 1014 — San Antonio, Texas, United States
• Viela Bio Investigative Site - 1017 — Salt Lake City, Utah, United States
• Viela Bio Investigative Site - 1004 — Burlington, Vermont, United States
• Viela Bio Investigative Site - 1006 — Richmond, Virginia, United States
• Viela Bio Investigative Site - 2001 — Buenos Aires, Argentina
• VielaBio Investigative Site - 2002 — Buenos Aires, Argentina
• Viela Bio Investigative Site - 2003 — Buenos Aires, Argentina
• Viela Bio Investigative Site - 5203 — Grodno, Belarus
• Viela Bio Investigative Site - 5204 — Minsk, Belarus
• Viela Bio Investigative Site - 5201 — Vitebsk, Belarus
• VielaBio Investigative Site - 2201 — Porto Alegre, Brazil
• VielaBio Investigative Site - 2203 — Porto Alegre, Brazil
• VielaBio Investigative Site - 2207 — Ribeirão Preto, Brazil
• Viela Bio Investigative Site - 1015 — Orange, California, United States

Full record on ClinicalTrials.gov

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