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NCT04524273 · ClinicalTrials.gov registry record · Phase 3
Myasthenia Gravis Inebilizumab Trial
A Phase 3 study of Myasthenia Gravis, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 238
- Enrollment target
- 20
- Study locations
NCT04524273: Active Phase 3 study of Myasthenia Gravis, sponsored by Amgen.
NCT04524273 is a Phase 3 study of Myasthenia Gravis that is active but no longer recruiting, run by Amgen. The registered enrollment target is 238 participants, above the 184-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04524273, a Phase 3 study of Myasthenia Gravis, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 238 participants
- Enrollment target
- 20
- Study locations
Study Summary
Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
Primary Outcome
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
Conditions Studied
Interventions
- DRUG IV Placebo
- DRUG inebilizumab
Study Locations (20)
Other
- Viela Bio Investigative Site - 2001 - Buenos Aires
- VielaBio Investigative Site - 2002 - Buenos Aires
- Viela Bio Investigative Site - 2003 - Buenos Aires
- Viela Bio Investigative Site - 5203 - Grodno
Ohio
- Viela Bio Investigative Site - 1025 - Canton
- Viela Bio Investigative Site - 1001 - Cincinnati
- Viela Bio Investigative Site - 1009 - Columbus
Texas
- Viela Bio Investigative Site - 1019 - Austin
- Viela Bio Investigative Site - 1003 - Houston
- Viela Bio Investigative Site - 1014 - San Antonio
California
- Viela Bio Investigative Site - 1015 - Orange
Connecticut
- Viela Bio Investigative Site - 1002 - New Haven
District of Columbia
- Viela Bio Investigative Center - 1024 - Washington D.C.
Florida
- Viela Bio Investigative Site - 1005 - Tampa
Kansas
- Viela Bio Investigative Site - 1012 - Kansas City
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 238 participants |
| Start Date | 2020-10-15 |
| Est. Completion | 2027-11-29 |
| Phase | Phase 3 |
What the registry record for NCT04524273 still lists
NCT04524273 is an interventional study that assigns participants to a tested intervention. The registered 238 participants enrollment target is mid-sized for trials with a published cap, above the 184-participant average among 32 other Myasthenia Gravis trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Myasthenia Gravis appearing as the primary indexed condition, and to 2 interventions - of which IV Placebo is the first listed.
NCT04524273 names 20 study sites across 13 states, led by Other, Ohio, Texas.
Frequently Asked Questions
What is clinical trial NCT04524273 about?
NCT04524273 is a clinical study titled "Myasthenia Gravis Inebilizumab Trial". Randomized, double-blind, placebo-controlled, Phase 3, parallel-group study with optional open-label extension.
What is the current status of trial NCT04524273?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 238 participants. The study started on 2020-10-15. Estimated completion is 2027-11-29.
What conditions does trial NCT04524273 study?
This clinical trial studies the following conditions: Myasthenia Gravis.
What interventions are being tested in trial NCT04524273?
The interventions under investigation include: IV Placebo (DRUG), inebilizumab (DRUG).
Who is sponsoring clinical trial NCT04524273?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04524273 being conducted?
This trial has 20 study locations across California, Connecticut, District of Columbia, Florida, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT04524273's enrollment target sits among peer trials
238 8th of 32 higher than 25 of 32 other Myasthenia Gravis trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Myasthenia Gravis trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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