A Phase 3, Multi-center, Randomized, Quadruple-blind, Placebo-controlled Study to Assess the Efficacy and Safety of Batoclimab as Induction andMaintenance Therapy in Adult Participants with Generalized Myasthenia Gravis (gMG).

Recruiting

18-100 years

All

Phase 3

2 participants needed

1 Location

Brief description of study

The purpose of the current Phase 3 study is to confirm the efficacy and safety of batoclimab in participants with gMG. The study will assess the efficacy of 2 different doses of subcutaneous injection of batoclimab compared to placebo as Induction Therapy. Additionally, in those participants who achieved a ≥ 2-point improvement from baseline in Myasthenia Gravis-Activities of Daily Living (MG-ADL) score with Induction Therapy, the study will assess the efficacy of 2 doses of batoclimab compared to placebo as Maintenance Therapy.

Detailed description of study

This study includes 5 periods: a 35-day Screening Period, a 12-week placebo-controlled Induction Period (Period 1), a 12-week Maintenance Period (Period 2), a 52-week long-term extension (LTE) (Period 3), and a 52-week optional long-term extension (OLTE) (Period 4). The total study duration will be approximately 133 weeks. Subjects will be randomized to receive treatment with batoclimab every week or every other week.

Eligibility of study

You may be eligible for this study if you meet the following criteria:

Conditions:
gMG,Generalized myasthenia gravis
Age: Between 18 Years - 100 Years
Gender: All

Inclusion Criteria:

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.

Exclusion Criteria:

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.

Updated on 09 Mar 2024. Study ID: 852992

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