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NCT06860633 · ClinicalTrials.gov registry record · Phase 4
Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod
A Phase 4 study of Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations, sponsored by University of Colorado, Denver.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 20
- Enrollment target
- 1
- Study location
NCT06860633: Recruiting Phase 4 study of Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations, sponsored by University of Colorado, Denver.
NCT06860633 is a Phase 4 study of Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations that is actively recruiting participants, run by University of Colorado, Denver. The registered enrollment target is 20 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06860633, a Phase 4 study of Myasthenia Gravis Crisis and Myasthenia Gravis Exacerbations, is actively recruiting participants, sponsored by University of Colorado, Denver.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 20 participants
- Enrollment target
- 1
- Study location
Study Summary
This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine receptor (AChR) antibody positive but has not been studied in the treatment of worsening weakness requiring hospital admission (known as "exacerbation"). This investigation aims to see if using efgartigimod in this way improves symptoms and recovery from exacerbation, and how it affects certain MG markers in the blood. The main questions it aims to answer are: * Is efgartigimod effective as a hospital-administered acute therapy for participants with worsening MG (MG exacerbation) who require hospitalization? * Will efgartigimod lead to clinical improvement with a similar reduction in validated research scales, such as the Quantitative MG (QMG) scale, as standard of care therapies? Participants will receive 4 doses of efgartigimod over the course of 4 weeks with an additional follow-up visit at the clinic.
Primary Outcome
The Quantitative Myasthenia Gravis (QMG) is a scoring system that quantifies disease severity by measuring ocular, bulbar, respiratory and limb strength. The total scores range from 0 to 39, with higher scores indicating greater disease severity.
Conditions Studied
Interventions
- DRUG Efgartigimod
Study Locations (1)
Colorado
- University of Colorado - Aurora
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 20 participants |
| Start Date | 2025-03-06 |
| Est. Completion | 2026-12-31 |
| Phase | Phase 4 |
What NCT06860633 shows while recruiting
NCT06860633 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 20 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (96% lower).
The record links to 3 conditions, with Myasthenia Gravis Crisis appearing as the primary indexed condition, and to 1 intervention - of which Efgartigimod is the first listed.
NCT06860633 reports a single indexed study location in Colorado.
Frequently Asked Questions
What is clinical trial NCT06860633 about?
NCT06860633 is a clinical study titled "Treatment of Myasthenia Gravis Exacerbation or Crisis With Efgartigimod". This study plans to learn more about if the drug efgartigimod can be used in the hospital to treat exacerbations in participants with myasthenia gravis (MG). Efgartigimod has been approved by the FDA for ongoing (chronic) treatment of generalized MG in adult patients who are anti-acetylcholine recep...
What is the current status of trial NCT06860633?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 20 participants. The study started on 2025-03-06. Estimated completion is 2026-12-31.
What conditions does trial NCT06860633 study?
This clinical trial studies the following conditions: Myasthenia Gravis Crisis, Myasthenia Gravis Exacerbations, AChR Myasthenia Gravis.
What interventions are being tested in trial NCT06860633?
The interventions under investigation include: Efgartigimod (DRUG).
Who is sponsoring clinical trial NCT06860633?
This trial is sponsored by University of Colorado, Denver, which has 1,283 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06860633 being conducted?
This trial has 1 study location across Colorado. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06860633's enrollment target sits among peer trials
20 1753rd of 2000 higher than 168 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 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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