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Clinical Trials in Denmark / NCT04524273
Active, not recruiting Phase 3

Myasthenia Gravis Inebilizumab Trial

NCT04524273 · tracked via the Priya Life Science Denmark tracker
Sponsor
Phase
Phase 3
Started
2020-10-15
Last updated
2026-05-15

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

inebilizumab →IV Placebo

inebilizumab: Participants will receive IV inebilizumab

IV Placebo: Participants will receive IV placebo matched to inebilizumab

Study summary

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

Eligibility

Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria: 1. Diagnosis of MG with anti-AChR or anti-MuSK antibody. 2. MGFA Clinical Classification Class II, III, or IV. 3. MG-ADL score of 6 or greater at screening and at randomization with \> 50% of this score attributed to non-ocular items. 4. QMG score of 11 or greater. 5. Participants must be on: 1. Corticosteroids only, with no dose increase within 4 weeks prior to randomization, or 2. 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 3. 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. Exclusion Criteria: 1. Receipt of the following medications within the 4 weeks prior to Day 1: 1. Cyclosporine (except eye drops) 2. Tacrolimus (except topical) 3. Methotrexate 2. Current use of: 1. Corticosteroids (Prednisone \> 40 milligram (mg)/day or \> 80 mg over a 2-day period (or equivalent dose of other corticosteroids). 2. Acetylcholinesterase inhibitors (pyridostigmine) \> 480 mg/day) or unstable dose in the 2 weeks prior to Day 1. 3. Azathioprine \> 3 mg/kilogram (kg)/day 4. Mycophenolate mofetil \> 3 grams/day or mycophenolic acid \> 1440 mg/day 5. Any IST, alone or in combination with corticosteroids, except for azathioprine, mycophenolate mofetil, and mycophenolic acid.

Primary outcome measure(s)

Trial sites (104)

FacilityCityRegionStatus
Viela Bio Investigative Site - 1015 Orange California
Viela Bio Investigative Site - 1002 New Haven Connecticut
Viela Bio Investigative Center - 1024 Washington D.C. District of Columbia
Viela Bio Investigative Site - 1005 Tampa Florida
Viela Bio Investigative Site - 1012 Kansas City Kansas
Viela Bio Investigative Site - 1018 Charlotte North Carolina
Viela Bio Investigative Site - 1025 Canton Ohio
Viela Bio Investigative Site - 1001 Cincinnati Ohio
Viela Bio Investigative Site - 1009 Columbus Ohio
Viela Bio Investigative Site - 1008 Pittsburgh Pennsylvania
Viela Bio Investigative Site - 1019 Austin Texas
Viela Bio Investigative Site - 1003 Houston Texas
Viela Bio Investigative Site - 1014 San Antonio Texas
Viela Bio Investigative Site - 1017 Salt Lake City Utah
Viela Bio Investigative Site - 1004 Burlington Vermont
Viela Bio Investigative Site - 1006 Richmond Virginia
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
VielaBio Investigative Site - 2206 São Paulo Brazil
Viela Bio Investigative Site - 2205 São Paulo Brazil
Viela Bio Investigative Site - 1102 Toronto Ontario
Viela Bio Investigative Site - 1101 Montreal Quebec
Viela Bio Investigative Site - 1103 Montreal Quebec
Viela Bio Investigative Site 4009 Beijing China
Viela Bio Investigative Site - 4007 Beijing China
Viela Bio Investigative Site 4003 Beijing China
Viela Bio Investigative Site - 4005 Guiyang China
Viela Bio Investigative site 4010 Hunan China
Viela Bio Investigative Site - 4011 Jinan China
Viela Bio Investigative Site - 4006 Shanghai China
Viela Bio Investigative Site - 4008 Suzhou China
Viela Bio Investigative Site - 4004 Tianjin China
Viela Bio Investigative Site 4012 Xi'an China

+ 64 more sites — see the full list on the official registry below.

More Amgen trials in Denmark

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04524273 on ClinicalTrials.gov ↗ ← All trials in Denmark