Clinical Trials in Spain / NCT04524273
Active, not recruiting
Phase 3
Myasthenia Gravis Inebilizumab Trial
NCT04524273 · tracked via the Priya Life Science Spain tracker
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
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)
- Change From Baseline at Week 26 in Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the Overall Study Population — Baseline and Week 26
MG-ADL score is an 8-item questionnaire that focuses on relevant symptoms and functional performance of activities of daily living over the previous 7 days. The MG-ADL score assesses disability secondary to ocular (2 items), bulbar (3 items), respiratory (1 item) and gross motor or limb (2 items) impairment related to effects from MG. Each response is graded 0 (normal) to 3 (most severe). The range of total MG-ADL scores is 0-24. A higher score represents more severe disease Outcome measure is reported for the overall population.
Trial sites (104)
| Facility | City | Region | Status |
|---|---|---|---|
| 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.
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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 Spain