Phase 3 Myasthenia Gravis Trial, Recruiting NCT06517758 Sponsor: Novartis Pharmaceuticals Condition: Myasthenia Gravis
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Phase 3 Myasthenia Gravis Trial, Recruiting

NCT06517758
Recruiting Phase 3 🇦🇺 Australian site

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 between 18 and 85 years old and have been diagnosed with generalized Myasthenia Gravis (gMG)
  • A blood test has confirmed you have a specific antibody associated with Myasthenia Gravis (called AChR+ antibody)
  • Your Myasthenia Gravis is at a moderate to severe level, and your doctor does not expect you to need a breathing machine during the study
  • Your diagnosis has been confirmed by at least one of: a nerve/muscle electrical test, a positive response to a short-acting medication test, or noticeable improvement in your symptoms when taking Myasthenia Gravis medication
  • Your Myasthenia Gravis symptoms significantly affect your daily life (based on a specific score), and most of those difficulties are caused by symptoms other than eye-related issues
  • You have been receiving at least one established treatment for Myasthenia Gravis for at least 6 months before joining the study (this could include certain immune-suppressing drugs, regular plasma treatments, an approved FcRn-blocking drug, rituximab, or other approved Myasthenia Gravis treatments — but not complement inhibitors)
  • You have received, or are willing to receive, certain vaccines (against meningitis and pneumococcal infections) at least 2 weeks before starting the study treatment (confirm with trial site for US-specific requirements)

Who may not be able to join:

  • You have recently received certain treatments, including: IVIG or plasma exchange in the past month; rituximab in the past 6 months; eculizumab in the past 2 months; ravulizumab or other complement inhibitors in the past 3 months; efgartigimod or similar therapies in the past 3 months; or you have had, or are planning, a thymus gland removal surgery within 6 months
  • You currently have a significant active or long-term uncontrolled bacterial, viral, or fungal infection
  • You have active Hepatitis B, active Hepatitis C, or HIV with a serious related condition or very low immune cell count (confirm with trial site)
  • You are pregnant, breastfeeding, or planning to become pregnant
  • You are a woman capable of becoming pregnant and are not willing or able to use effective contraception during the study and for one week after the last dose
  • You have had a serious infection requiring hospitalisation or injected antibiotics within the 14 days before starting the study treatment
  • You have a history of repeated serious infections caused by certain bacteria (such as meningococcal or pneumococcal infections)
  • You have had a fever of 38°C (100.4°F) or higher within the 7 days before starting the study treatment

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 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 1-888-669-6682

Australian sites

Novartis Investigative Site, Camperdown, Sydney

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 3
Registry
ClinicalTrials.gov
Start date
31 July 2024
Est. completion
30 April 2027

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇳 China 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇬🇷 Greece 🇮🇱 Israel 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇵🇹 Portugal 🇷🇸 Serbia 🇰🇷 South Korea 🇪🇸 Spain 🇬🇧 United Kingdom 🇺🇸 United States

1 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

Change from baseline to Month 6 in Myasthenia Gravis Activity of Daily Living (MG-ADL) total score

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