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NCT04963270 · ClinicalTrials.gov registry record · Phase 3
A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis
A Phase 3 study, sponsored by Hoffmann-La Roche.
- Terminated
- Registry status
- Phase 3
- Development phase
- 188
- Enrollment target
NCT04963270: Clinical Trial Phase 3 study, sponsored by Hoffmann-La Roche.
NCT04963270 is a Phase 3 study that was terminated before completion, run by Hoffmann-La Roche. The registered enrollment target is 188 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04963270, a Phase 3 study, was terminated before completion, sponsored by Hoffmann-La Roche.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 188 participants
- Enrollment target
Study Summary
This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
Primary Outcome
The MG-ADL scale was used to assess the degree of gMG symptoms (six items: diplopia, ptosis, difficulties with chewing, swallowing, talking, and respiratory problems) and functional limitations in carrying out activities of daily living (two items: ability to brush teeth or comb hair and impairment in the ability to arise from a chair) that are present and clinically relevant in gMG participants. Each of the eight items was ranked on a 0-3 scale, with 3 representing the most severe symptoms or i
Interventions
- OTHER Placebo
- DRUG Satralizumab
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 188 participants |
| Start Date | 2021-10-19 |
| Est. Completion | 2024-09-02 |
| Phase | Phase 3 |
Why NCT04963270 stopped before completion
NCT04963270 is an interventional study that assigns participants to a tested intervention. The registered 188 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (76% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04963270 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04963270 about?
NCT04963270 is a clinical study titled "A Study To Evaluate Efficacy, Safety, Pharmacokinetics, And Pharmacodynamics Of Satralizumab In Patients With Generalized Myasthenia Gravis". This study will evaluate the efficacy, safety, pharmacokinetics, and pharmacodynamics of satralizumab compared with placebo in participants with generalized myasthenia gravis (gMG).
What is the current status of trial NCT04963270?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 188 participants. The study started on 2021-10-19. Estimated completion is 2024-09-02.
What interventions are being tested in trial NCT04963270?
The interventions under investigation include: Placebo (OTHER), Satralizumab (DRUG).
Who is sponsoring clinical trial NCT04963270?
This trial is sponsored by Hoffmann-La Roche, which has 909 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04963270's enrollment target sits among peer trials
188 1408th of 2000 higher than 591 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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.
Source ClinicalTrials.gov registry export · 2026-08-08
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