Phase 3 Myasthenia Gravis Trial, Recruiting NCT07217587 Sponsor: Janssen Research & Development, LLC Condition: Myasthenia Gravis
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Phase 3 Myasthenia Gravis Trial, Recruiting

NCT07217587
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 in generally stable health, based on a physical exam, blood tests, heart tracing (ECG), and medical history done at the screening visit.
  • You have been diagnosed with myasthenia gravis (MG) that affects muscles throughout your body (not just your eyes), and your condition falls into a moderate-to-severe category as defined by a standard MG grading system (MGFA class II, III, or IV).
  • Your blood test shows a specific antibody linked to MG (called acetylcholine receptor, or AChR, antibody).
  • Your MG symptoms score on a daily living questionnaire (MG-ADL) is 5 or higher, and fewer than half of those points come from eye-related symptoms — measured at both your screening and first study visits.

If you are joining Arms 1 or 2 only:

  • Your current MG treatment is not working well enough, according to your doctor, OR you have stopped certain MG medications (such as steroids or immune-suppressing drugs) at least 4 weeks before the study starts, because they caused side effects or did not work.

If you are joining Arm 3 only:

  • You have already received at least one full course of a specific MG treatment called efgartigimod (given by drip or injection), and your last course followed the standard guidelines for that medicine.

Who may not be able to join:

  • You have a confirmed or suspected immune system disorder unrelated to your MG treatment, or you have a family history of an inherited immune system condition (unless tests confirm you do not have it).
  • You had your thymus gland removed (thymectomy) within the past year, or you are planning to have this surgery during the study.
  • You currently have cancer, or you have had cancer at any point in the 3 years before joining the study.

If you are joining Arms 1 or 2 only:

  • You have previously been treated for MG with a type of medication that targets a protein called FcRn (confirm with trial site if unsure whether your medication falls into this category).

If you are joining Arm 3 only:

  • You are currently taking certain types of medications called IgG monoclonal antibodies or similar treatments (including some replacement therapies), unless that medication is efgartigimod.

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

Principal Investigator: Janssen Research & Development, LLC Clinical Trial, Janssen Research & Development, LLC

Phone: 844-434-4210

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
5 January 2026
Est. completion
28 September 2027

Where this trial is recruiting

🇮🇱 Israel 🇨🇭 Switzerland 🇺🇸 United States

Primary endpoints

Arms 1 and 2: Averaged Mean Percent Change from Baseline in Total Immunoglobulin G (IgG) Levels Over Weeks 8, 10 and 12

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