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Phase 3 Study to Assess Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG)
EU CTIS ID: 2024-512258-91-00
What this study is testing
To evaluate the efficacy of batoclimab 680 mg SC QW or 340 mg SC QW compared to placebo as Induction Therapy in AChRAb+ participants as assessed by change in the Myasthenia Gravis Activities of Daily Living (MG-ADL) score.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Are ≥ 18 years of age at the Screening Visit.
- Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
- Have a QMG score ≥ 11 at the Screening and Baseline Visits.
- Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
- Additional inclusion criteria are defined in the protocol.
You likely can't join if
- Have experienced myasthenic crisis within 3 months of the Screening Visit.
- Have had a thymectomy performed < 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
- Have any active or untreated malignant thymoma.
- Have received any agent or therapy (exclusive of those identified within inclusion criteria) with immunosuppressive properties (e.g., stem cell therapy, chemotherapies, etc.) within the past year.
- Have used anti-FcRn treatment within 3 months prior to the Screening Visit or have a documented history of non-response to prior anti-FcRn treatment.
- Additional exclusion criteria are defined in the protocol.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Japan
- Serbia
- Canada
- United States
- United Kingdom
- Mexico
- Argentina
- Brazil
- Georgia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Japan; Serbia; Canada; United States; United Kingdom and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.