Phase 4 Myasthenia Gravis Trial, Recruiting NCT06860633 Sponsor: University of Colorado, Denver Condition: Myasthenia Gravis
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Phase 4 Myasthenia Gravis Trial, Recruiting

NCT06860633
Recruiting Phase 4

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • You are 18 years of age or older and have been diagnosed with generalized Myasthenia Gravis (MG), a condition where the immune system attacks the connection between nerves and muscles, confirmed by blood tests showing specific antibodies
  • Your MG diagnosis has been supported by at least one of the following: a positive response to a medication that helps nerve-muscle communication, an abnormal result on a nerve stimulation test, or an abnormal result on a specialized muscle electrical activity test
  • Your MG symptoms are getting worse and serious enough to require a hospital stay, as confirmed by a specialist using specific MG scoring tools that measure weakness and how it affects daily life
  • Your worsening symptoms may include breathing problems, trouble speaking, swallowing or chewing, limb weakness, double vision, or drooping eyelids
  • You are able to give written consent and be enrolled in the study within 24 hours of being admitted to hospital

Who may not be able to join:

  • Your MG worsening appears to be caused by an active infection or by certain medications (such as some antibiotics or other specific drugs)
  • You needed to be put on a breathing machine (ventilator) before you could give consent, or within 24 hours of being admitted to hospital
  • You have received a treatment called IVIG in the last 2 weeks, or have had plasma exchange, or received a drug called efgartigimod in the last 4 weeks before admission
  • You are currently taking ravulizumab or eculizumab (a type of medication that affects the immune system)
  • You have other medical conditions that, in the doctor's judgment, could affect how your muscle strength is measured during the study — for example, severe arthritis, bone fractures, or certain nerve or brain conditions (confirm with trial site)
  • You have a known history of blood clotting problems or have recently had serious bleeding, such as bleeding in the stomach or gut
  • You are currently pregnant or breastfeeding; pregnancy will need to be ruled out before starting treatment if there is any possibility you could become pregnant
  • Your blood levels of a protein called IgG are too low (below 600mg/dL)
  • You have an active or long-term Hepatitis B infection, untreated Hepatitis C infection, or HIV with a weakened immune system (confirm with trial site)

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 28 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Thomas Ragole, MD, University of Colorado, Denver

Phone: 303.724.3522

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 4
Registry
ClinicalTrials.gov
Start date
6 March 2025
Est. completion
31 December 2026

Where this trial is recruiting

🇺🇸 United States

Primary endpoints

Change from baseline in the Quantitative Myasthenia Gravis (QMG) score at day 11

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 28 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov