Phase 3 Myasthenia Gravis Trial, Terminated NCT04963270 Sponsor: Hoffmann-La Roche Condition: Myasthenia Gravis
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Trial results

AI generated results 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

According to the results reported on ClinicalTrials.gov, this trial (NCT04963270) looked at a medicine called satralizumab in people with a condition called generalised myasthenia gravis (gMG) — a disease that causes muscle weakness affecting things like swallowing, speaking, breathing, and everyday movements. A total of 188 people took part in the main 24-week double-blind phase, with 92 receiving a placebo (an inactive dummy injection) and 96 receiving satralizumab. Neither the participants nor the medical team knew who was getting which treatment during this phase. The main thing being measured was change in a symptom score called the MG-ADL, which rates how much the disease affects daily activities on a scale from 0 (no problems) to 24 (most severe). The reported data shows that, in the main 24-week period, participants in the placebo group who had a specific antibody type (AChR+) had an average reduction in their MG-ADL symptom score of about 2.6 points, while those receiving satralizumab had an average reduction of about 3.6 points. When looking at all participants regardless of antibody type, the reported reductions were similar — around 2.5 points for the placebo group and 3.5 points for the satralizumab group. For a separate doctor-assessed score called the QMG (also measuring disease severity, scored 0–39), the reported average reductions were approximately 1.8 points (placebo) and 3.4 points (satralizumab) in the AChR+ group, and roughly 1.7 points (placebo) and 3.4 points (satralizumab) across all participants. The reported data also shows that, at 24 weeks, about 59% of placebo participants and about 71% of satralizumab participants in the AChR+ group had their MG-ADL score reduce by at least 2 points — a threshold the researchers used to define a meaningful change. Across all participants, the figures were approximately 61% and 70% respectively. The trial also included a longer open-label extension phase of 92 weeks where all continuing participants received satralizumab, but completion figures for that phase were not reported in the submitted data. These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 3 Myasthenia Gravis Trial, Terminated

NCT04963270
Terminated 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 have agreed to take part and signed a consent form (for teenagers, a parent or guardian must also sign, and the young person must agree to join)
  • You are able to follow the study schedule and procedures
  • You have been diagnosed with a type of myasthenia gravis (MG) confirmed by a specific antibody test (anti-AChR, anti-MuSK, or anti-LRP4) done at the screening visit
  • Your MG symptoms score (called MG-ADL) is 5 or higher, and more than half of those points come from symptoms affecting parts of the body other than the eyes
  • Your MG severity falls within a moderate-to-severe range as measured by a standard scale (MGFA Class II, III, or IV)
  • You are already receiving treatment for MG and have been on a steady, unchanged dose
  • If you are a woman who could become pregnant, you agree to avoid pregnancy by abstaining from sex or using reliable contraception during the study and for at least 3 months after your last dose of the study medicine

Who may not be able to join:

  • You had surgery to remove your thymus gland within the past 12 months
  • Your MG only affects your eyes (MGFA Class I), or you have had a severe MG crisis (MGFA Class V) in the last 3 months
  • You have another medical condition that could interfere with the study (confirm with trial site)
  • Your blood tests show signs of hepatitis B or hepatitis C infection
  • There are signs that you have active or hidden (latent) tuberculosis, unless you are already taking medication to prevent it
  • You have received a live vaccine within 6 weeks before the study starts
  • You are currently pregnant or breastfeeding, or you plan to become pregnant during the study or within 3 months after your last dose

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: Clinical Trials, Hoffmann-La Roche

Australian sites

Concord Repatriation General Hospital, Concord, New South Wales

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Terminated
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
19 October 2021
Est. completion
29 January 2024

Where this trial is recruiting

🇦🇷 Argentina 🇦🇺 Australia 🇧🇷 Brazil 🇨🇦 Canada 🇨🇳 China 🇩🇰 Denmark 🇫🇷 France 🇩🇪 Germany 🇮🇹 Italy 🇯🇵 Japan 🇵🇱 Poland 🇷🇺 Russia 🇰🇷 South Korea 🇪🇸 Spain 🇹🇼 Taiwan Turkey (Türkiye) 🇺🇸 United States

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

Primary endpoints

DB Period: Mean Change From Baseline in Total Myasthenia Gravis Activities of Daily Living (MG-ADL) Score in the AChR+ Population

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