Phase 3 Myasthenia Gravis Trial, Recruiting NCT06447597 Sponsor: Shanghai Jiaolian Drug Research and Development Co., Ltd Condition: Myasthenia Gravis
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Phase 3 Myasthenia Gravis Trial, Recruiting

NCT06447597
Recruiting Phase 3

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 willing and able to sign a consent form agreeing to take part in the study
  • You have been diagnosed with generalized myasthenia gravis (a condition that causes muscle weakness throughout the body)
  • A blood test taken during the screening period shows that you are positive for either AChR or MuSK antibodies (proteins linked to myasthenia gravis)
  • Your myasthenia gravis symptoms are scoring 5 or above on a standard daily activities scale (MG-ADL) at the time of screening and at the start of the trial
  • Before joining the trial, you have been taking at least one standard approved treatment for myasthenia gravis at a stable dose, and you are willing to keep that dose the same throughout the study
  • You agree to use effective birth control from the time you sign the consent form until 1 year after your last dose, and if you could become pregnant, you must have a negative pregnancy blood test before your first dose

Who may not be able to join:

  • You have a specific type of myasthenia gravis classified as MGFA Class I or Class V (confirm with trial site)
  • You are currently taking certain medications that are not allowed in this trial (confirm with trial site for specific drugs)
  • You have certain medical conditions or a history of certain illnesses that are not permitted in this trial (confirm with trial site for specific conditions)
  • Your test results show abnormalities that the study doctor feels make it unsafe for you to participate
  • You have a known history of severe allergic reactions to humanized monoclonal antibody medicines, or you are allergic to any ingredient in the study drug (B007)
  • You have received a live vaccine too close to the start of the trial, or you plan to receive one too soon after your last dose (confirm with trial site for specific timeframes)
  • You have had major surgery or taken part in another clinical trial too recently before screening (confirm with trial site for specific timeframes)
  • You are currently pregnant or breastfeeding
  • You are a woman who could become pregnant but are not willing to use effective birth control from signing the consent form until 1 year after your last dose
  • You are a sexually active man who is not willing to use effective birth control during the trial and for 1 year after your last dose, or who plans to donate sperm during the trial or within 1 year after your last dose
  • You have a history of alcohol or drug misuse within the past 12 months
  • The study doctors have identified any other reason they feel makes it unsuitable for you to participate

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: 0086-021-52888045

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
Sponsor
Shanghai Jiaolian Drug Research and Development Co., Ltd
Registry
ClinicalTrials.gov
Start date
1 July 2024
Est. completion
30 June 2026

Where this trial is recruiting

🇨🇳 China

Primary endpoints

Proportion of subjects:MG-ADL(Myasthenia gravis-activities of daily living profile) decreased by ≥2

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