Actively Recruiting
Seronegative Myasthenia Gravis - Efgartigimod IV
Led by University Health Network, Toronto · Updated on 2024-09-19
30
Participants Needed
1
Research Sites
100 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
This is to study the efficacy, safety and tolerability of efgartigimod in patients with seronegative generalized myasthenia gravis. This is an open label study. There will be 30 participants to enroll at University Health Network Toronto General Hospital. Study duration is 43 weeks from screening to end of study.
CONDITIONS
Official Title
Seronegative Myasthenia Gravis - Efgartigimod IV
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent and willingness to comply with the study protocol and visits
- Male or female aged 18 years or older
- Diagnosis of seronegative generalized myasthenia gravis confirmed by clinical signs, abnormal neuromuscular transmission test, negative anti-AChR and anti-MuSK antibodies, and limited response to immunotherapy or acetylcholinesterase treatment
- MGFA Clinical Classification Class II, III, or IV at screening and baseline
- Moderate to severe myasthenia gravis with MG impairment index score above 11 or MG-ADL score of at least 5 with predominantly non-ocular symptoms
- Stable or worsening disease as shown by stable or increasing MGII score during 4-week run-in period
- Stable dose of standard myasthenia gravis treatment (acetylcholinesterase inhibitors, steroids, or immunosuppressants) for at least one month prior to screening
- Patients who discontinued previous efgartigimod trials early for reasons other than pregnancy, rescue therapy, or serious adverse events
- Females of childbearing potential must use highly effective contraception during study and for 3 months after last dose
- Non-sterilized males sexually active with female partners of childbearing potential must use condoms during study and for 3 months after last dose
- Normal or clinically acceptable vital signs, ECG, and laboratory tests at screening
- Documented IgG levels above 6 g/L within one month of screening
- COVID-19 vaccination at least 2 weeks prior to screening
You will not qualify if you...
- Early discontinuation from efgartigimod trials due to pregnancy, rescue therapy, or serious adverse events posing life-threatening or serious safety risks
- Pregnant or breastfeeding women, or women intending to become pregnant during the study or within 3 months after last dose
- Males not willing to use effective contraception or planning to donate sperm during study or within 3 months after last dose
- Known positive tests for hepatitis B, hepatitis C, or HIV
- Autoimmune diseases other than myasthenia gravis that may interfere with symptom assessment
- Significant other diseases or recent major surgery that may affect study results or participant safety
- Impaired kidney or liver function as defined by specified laboratory thresholds
- Known allergy to efgartigimod components
- Use of rituximab or eculizumab within 6 months before screening
- Thymectomy within 3 months before screening
- Intravenous immunoglobulin or plasma exchange within 4 weeks before screening
- Active or uncontrolled bacterial, viral, or fungal infections at screening
- Receipt of live or live-attenuated vaccines within 1 month before screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University Health Network, Division of Neurology, Toronto General Hospital
Toronto, Ontario, Canada, M5G 2C4
Actively Recruiting
Research Team
E
Eduardo Ng
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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