Myasthenia Gravis Trial, Recruiting NCT07570589 Sponsor: Centre Hospitalier Universitaire de Nice Condition: Myasthenia Gravis
Back to Myasthenia Gravis

Myasthenia Gravis Trial, Recruiting

NCT07570589
Recruiting Not Applicable

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 old or older
  • You have been diagnosed with Myasthenia Gravis (MG), confirmed by a doctor's examination and blood tests showing specific antibodies (anti-AChR or anti-MuSK)
  • Your MG affects more than just your eyes and falls into a moderate-to-severe category as defined by the Myasthenia Gravis Foundation of America (class IIa, IIb, IIIa, or IIIb) (confirm with trial site)
  • Your blood protein (IgG) levels are high enough to be suitable for the study treatment (confirm with trial site)
  • You have either never received the study treatment (rozanolixizumab) before, or your last dose was more than 3 months ago
  • Your MG symptoms score at least 3 points on a standard scale, with at least 3 of those points coming from symptoms not related to the eyes
  • You are up to date with all required vaccinations in your country
  • You are able to understand and sign a consent form agreeing to take part
  • You are willing and able to attend all appointments and follow all study requirements
  • You are covered by a European social security system

Who may not be able to join:

  • You have a mental health condition, dementia, or a low score on a standard memory and thinking test that might affect your ability to take part safely
  • You have any other illness or health condition that the study doctor believes could affect the results or put you at extra risk
  • You have or have had a cancer (except certain fully treated skin cancers or a fully treated cervical condition)
  • You currently have a significant bacterial, viral, or fungal infection that is not under control
  • You are currently being treated with certain other medications, including rituximab, anti-FcRn therapies, complement inhibitors, or plasma exchange (PLEX)
  • You previously stopped taking rituximab without following the specific rules required before starting this study treatment (confirm with trial site)
  • You have a very advanced illness that would prevent you from being properly assessed or treated during the study
  • You have an active infection that is not being treated
  • You are known to be allergic to the study drug or any of its ingredients, including histidine, proline, or polysorbate 80
  • You are, or a close family member is, directly involved in running this study at the trial site
  • You are protected by law, under guardianship, or are otherwise unable to participate in a clinical trial under French public health law

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
This study is not part of the standard drug-approval phase pathway (for example an observational, device, behavioural, or registry study), so a phase success rate does not apply.

GP referral letter

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

Trial details

Status
Recruiting
Phase
Not Applicable
Registry
ClinicalTrials.gov
Start date
15 June 2026
Est. completion
1 March 2028

Where this trial is recruiting

🇫🇷 France

Primary endpoints

To assess in real-life the impact of the ROZ on MG symptoms PRO score in generalized MG patients with anti-AChR or anti-MUSK antibodies

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