Status:
ACTIVE_NOT_RECRUITING
Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis
Lead Sponsor:
Immunovant Sciences GmbH
Conditions:
Generalized Myasthenia Gravis
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this 4-period study is to confirm the efficacy and safety of batoclimab in participants with gMG. In Period 1, participants will be randomized 1:1:1 to receive batoclimab 680 milligrams...
Eligibility Criteria
Inclusion
- 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
- 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) 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.
Key Trial Info
Start Date :
June 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2025
Estimated Enrollment :
240 Patients enrolled
Trial Details
Trial ID
NCT05403541
Start Date
June 27 2022
End Date
April 1 2025
Last Update
August 7 2024
Active Locations (105)
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1
Site Number -1022
Phoenix, Arizona, United States, 85028
2
Site Number -1029
Scottsdale, Arizona, United States, 85251
3
Site Number -1002
Carlsbad, California, United States, 92011
4
Site Number -1009
Irvine, California, United States, 92697