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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 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. The trial reports 1 study location across 1 state.

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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.

Interventions

  • DRUG Efgartigimod

Study Locations (1)

Colorado

  • University of Colorado - Aurora

Trial Details

FieldValue
Enrollment Target 20 participants
Start Date 2025-03-06
Est. Completion 2026-12-31
Phase Phase 4

Sponsor

University of Colorado, Denver

1,283 total trials

What the Registry Record Tells You About NCT06860633

The ClinicalTrials.gov registry entry for NCT06860633 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 20 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is University of Colorado, Denver, which has 1,283 total studies on file at ClinicalTrials.gov.

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 1 study location spanning 1 distinct geographic area - top geographies include 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.

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