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Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis

NCT05403541

Active Not RecruitingPhase 3

Sponsor: Immunovant Sciences GmbH

Conditions: Generalized Myasthenia Gravis

Interventions: Batoclimab 680 mg SC weekly, Batoclimab 340 mg SC weekly, Matching Placebo SC, Batoclimab 340 mg SC bi-weekly

Countries: United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy

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 (mg) subcutaneously (SC) once a week (QW) or 340 mg SC QW or placebo. The primary efficacy endpoint will be assessed by change in the myasthenia gravis activities of daily living (MG- ADL) score in acetylcholine receptor antibody seropositive (AChRAb+) participants. In Period 2, participants previously treated with batoclimab will be re-randomized to stay on batoclimab (340 mg SC QW or 340 mg SC every two weeks) or receive placebo treatment. The secondary endpoint of maintenance of efficacy will be assessed by change in the MG- ADL score in AChRAb+ participants. Participants demonstrating a response to batoclimab during either Period 1 or 2 may enter the long-term extension (Period 3). Participants who complete Period 3 are eligible to participate in Period 4 (Optional Long-Term extension) according to their treatment assignment in Period 3.

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

1. Are ≥ 18 years of age at the Screening Visit.
2. Have mild to severe gMG by Myasthenia Gravis Foundation of America (MGFA) classification Class II, III, or IVa at the Screening Visit.
3. Have a QMG score ≥ 11 at the Screening and Baseline Visits.
4. Have a MG-ADL score of ≥ 5 at the Screening and Baseline Visits.
5. Additional inclusion criteria are defined in the protocol.

Exclusion Criteria:

1. Have experienced myasthenic crisis within 3 months of the Screening Visit.
2. Have had a thymectomy performed \< 6 months prior to the Screening Visit or have a planned thymectomy during the study period.
3. Have any active or untreated malignant thymoma.
4. 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.
5. 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.
6. Additional exclusion criteria are defined in the protocol.

Locations (93)

Phoenix, Arizona, United States
Scottsdale, Arizona, United States
Carlsbad, California, United States
Irvine, California, United States
Olive View, California, United States
San Francisco, California, United States
Aurora, Colorado, United States
New Haven, Connecticut, United States
Clearwater, Florida, United States
Maitland, Florida, United States
Miami, Florida, United States
Orlando, Florida, United States
Port Charlotte, Florida, United States
Tampa, Florida, United States
Fairway, Kansas, United States
Lexington, Kentucky, United States
East Lansing, Michigan, United States
Minneapolis, Minnesota, United States
Buffalo, New York, United States
Chapel Hill, North Carolina, United States
Durham, North Carolina, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Philadelphia, Pennsylvania, United States
Memphis, Tennessee, United States
Austin, Texas, United States
Dallas, Texas, United States
Houston, Texas, United States
Round Rock, Texas, United States
Charlottesville, Virginia, United States
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