Phase 4 Myasthenia Gravis Trial, Recruiting NCT07246564 Sponsor: UCB Biopharma SRL Condition: Myasthenia Gravis
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Phase 4 Myasthenia Gravis Trial, Recruiting

NCT07246564
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 must be 18 years of age or older at the time of signing the consent form
  • You have been diagnosed with generalized myasthenia gravis (a muscle weakness condition that affects the whole body, not just the eyes)
  • Your medical records show a positive test for specific antibodies linked to myasthenia gravis (either AChR or MuSK antibodies)
  • Your myasthenia gravis has been rated as moderate to severe (classified as Grade II to IV) by a doctor at your screening visit
  • Your myasthenia gravis symptoms — particularly those not related to your eyes — reach a certain level of severity based on two standard scoring tests used by doctors (confirm with trial site)
  • A doctor has decided that you would benefit from additional treatment for your condition
  • You weigh at least 35 kg (approximately 77 lbs) at your screening visit

Who may not be able to join:

  • You have had a known allergic reaction to the study drug or similar types of medications
  • You currently have an active or untreated infection that your doctor considers significant
  • You have a current or past tuberculosis (TB) infection, are at high risk of getting TB, have a latent (inactive) TB infection, or have had a similar type of bacterial infection
  • You have previously been treated with the specific study drug called rozanolixizumab
  • You have received any vaccine in the 4 weeks before starting the study treatment, or you plan to receive a vaccine within 2 weeks after your last dose of the study drug
  • You have recently taken certain medications — including some immune-suppressing drugs or biological treatments — that are not allowed within a required time period before joining (confirm with trial site)
  • You are currently experiencing severe weakness in your throat or breathing muscles, or you are having a myasthenia gravis crisis or are close to having one

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: UCB Cares, 001 844 599 22733 (UCB)

Phone: +18445992273

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
Sponsor
UCB Biopharma SRL
Registry
ClinicalTrials.gov
Start date
1 December 2025
Est. completion
15 October 2027

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Change from Baseline to Day 43 in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score in the first Treatment Cycle

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