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Satralizumab for Myasthenia Gravis

Phase 3
Recruiting
Research Sponsored by Hoffmann-La Roche
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Confirmed diagnosis of gMG (anti-AChR, anti-MuSK or anti-LRP4 present at screening)
Ongoing gMG treatment at a stable dose
Timeline
Screening 3 weeks
Treatment Varies
Follow Up week 24
Awards & highlights

Study Summary

This trial will test if satralizumab is safe and effective in treating generalized myasthenia gravis.

Who is the study for?
This trial is for individuals with generalized myasthenia gravis (gMG), a condition causing muscle weakness. Participants must have a confirmed diagnosis, be able to follow the study protocol, and if of childbearing potential, agree to use contraception or abstain from sex during the study and for 3 months after. Exclusions include recent thymectomy, certain vaccinations, pregnancy/breastfeeding intentions within study duration plus 3 months post-study, ocular MG or recent myasthenic crisis.Check my eligibility
What is being tested?
The trial is testing Satralizumab's effectiveness compared to a placebo in treating gMG. It will assess how well it works (efficacy), its safety profile, how the body processes it (pharmacokinetics), and what it does in the body (pharmacodynamics).See study design
What are the potential side effects?
While specific side effects are not listed here, common ones associated with medications like Satralizumab may include injection site reactions, increased risk of infections due to immune system suppression, potential liver issues indicated by hepatitis exclusion criteria.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have been diagnosed with generalized Myasthenia Gravis.
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I am currently on a stable dose of medication for myasthenia gravis.
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My parents or guardian and I have both agreed to my participation in the study.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~week 24
This trial's timeline: 3 weeks for screening, Varies for treatment, and week 24 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Mean change from baseline in Myasthenia Gravis Activities of Daily Living (MG-ADL) score in AChR-antibody seropositive population
Secondary outcome measures
Mean change from baseline in Myasthenia Gravis Quality of Life 15 Scale (MG-QOL 15r) score
Mean change from baseline in Quality of Life in Neurological Disorders (Neuro-QoL) Fatigue Subscale score
Mean change from baseline in Quantitative Myasthenia Gravis (QMG) score
+5 more

Side effects data

From 2021 Phase 3 trial • 85 Patients • NCT02028884
100%
Haemoglobin decreased
100%
Localised infection
100%
Abdominal pain
100%
Neutrophil count decreased
100%
White blood cell count decreased
100%
Oropharyngeal pain
100%
Ear infection
100%
White blood cell count increased
100%
Pruritus
100%
Rhinitis
100%
Rectal haemorrhage
100%
Diarrhoea
100%
Headache
100%
Hypotension
100%
Rash
100%
Haemorrhoids
100%
Tonsillitis
100%
Lymphocyte percentage decreased
100%
Lymphocyte percentage increased
100%
Monocyte count increased
100%
Neutrophil count increased
100%
Neutrophil percentage increased
100%
Platelet count increased
100%
Dysmenorrhoea
100%
80%
60%
40%
20%
0%
Study treatment Arm
Satralizumab Open-Label Period
Satralizumab + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Double Blind Period
Placebo + Baseline Treatment Open Label Period
Satralizumab + Baseline Treatment Open Label Period

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: SatralizumabExperimental Treatment1 Intervention
Participants will receive Satralizumab at Weeks 0, 2, 4, and Q4W thereafter. Adolescent patients who first enter the study in the OLE period will receive satralizumab SC loading doses at Week 0, 2, and 4 in the OLE, followed by maintenance doses Q4W thereafter and will remain on stable background therapy until Week 24 of the OLE.
Group II: PlaceboPlacebo Group1 Intervention
Participants will receive placebo at Weeks 0, 2, 4, and Q4W thereafter
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Satralizumab
2014
Completed Phase 3
~180

Find a Location

Who is running the clinical trial?

Hoffmann-La RocheLead Sponsor
2,427 Previous Clinical Trials
1,088,966 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
272 Patients Enrolled for Myasthenia Gravis
Chugai PharmaceuticalIndustry Sponsor
94 Previous Clinical Trials
21,334 Total Patients Enrolled
Clinical TrialsStudy DirectorHoffmann-La Roche
2,198 Previous Clinical Trials
888,406 Total Patients Enrolled
2 Trials studying Myasthenia Gravis
272 Patients Enrolled for Myasthenia Gravis

Media Library

Placebo Clinical Trial Eligibility Overview. Trial Name: NCT04963270 — Phase 3
Myasthenia Gravis Research Study Groups: Satralizumab, Placebo
Myasthenia Gravis Clinical Trial 2023: Placebo Highlights & Side Effects. Trial Name: NCT04963270 — Phase 3
Placebo 2023 Treatment Timeline for Medical Study. Trial Name: NCT04963270 — Phase 3

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any known serious side effects to taking Satralizumab?

"There is some evidence that suggests satralizumab is effective and multiple rounds of data that support its safety, thus it received a 3 on our safety scale."

Answered by AI

What have been the previous findings of other research groups when studying Satralizumab?

"There are currently 2 active clinical trials researching satralizumab. Of those, 2 are in Phase 3. Mendoza and Guipuzcoa have the most active trials for this medication, but there are a total of 181 clinical trial sites."

Answered by AI

Is this trial taking place at a lot of hospitals in North America?

"Currently, the study is live at 18 clinical sites. Some of these locations include Pasadena, Jacksonville and Chicago. To minimize the burden of travelling, it is encouraged that patients select the trial site closest to their location."

Answered by AI

Have patients undergone this experimental treatment before?

"There are 2 ongoing studies concerning the effects of satralizumab in 56 different cities and 26 countries. The first study, which was completed in 2021, was sponsored by Hoffmann-La Roche. It involved 127 patients and finished its Phase 3 drug approval stage. Since 2021, there have been 18240 similar studies conducted."

Answered by AI
~54 spots leftby Mar 2025