🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in India / NCT04524273
Active, not recruiting Phase 3

Myasthenia Gravis Inebilizumab Trial

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

Condition(s) studied

Myasthenia Gravis

Investigational drug(s) / intervention(s)

inebilizumabIV 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 India

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 India