Batoclimab for Myasthenia Gravis

Recruiting in Palo Alto (17 mi)

+108 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Immunovant Sciences GmbH

Pivotal Trial (Near Approval)

Prior Safety Data

Approved in 2 Jurisdictions

Trial Summary

What is the purpose of this trial?This trial is testing batoclimab, a medication given by injection, in patients with generalized Myasthenia Gravis who have specific antibodies. The goal is to see if it can improve their muscle strength and daily activities by lowering harmful antibodies. The study will also check if the benefits last over time. Batoclimab is being tested for its safety and potential efficacy in Chinese patients with generalized myasthenia gravis.

Eligibility Criteria

Adults over 18 with generalized Myasthenia Gravis (gMG) who experience muscle weakness. They should have specific scores on the QMG and MG-ADL scales, indicating mild to severe gMG. Those who've had a recent myasthenic crisis, thymectomy, untreated malignant thymoma, or certain immunosuppressive treatments are excluded.

Inclusion Criteria

My myasthenia gravis symptoms are moderate to severe.

Have a QMG score ≥ 11 at the Screening and Baseline Visits

Additional inclusion criteria are defined in the protocol.

+2 more

Exclusion Criteria

I haven't had treatments that weaken my immune system in the past year.

I had my thymus gland removed less than 6 months ago or will have it removed during the study.

I have used anti-FcRn treatment in the last 3 months or it didn't work for me before.

+3 more

Participant Groups

The trial is testing Batoclimab's effectiveness for gMG at different doses: 680 mg weekly or 340 mg weekly/bi-weekly versus placebo. It has three periods: initial treatment randomization, dose adjustment re-randomization for responders, and long-term extension for sustained response.

6Treatment groups

Experimental Treatment

Placebo Group

Group I: Batoclimab Maintenance Dose 2 (Period 2)Experimental Treatment1 Intervention

Group II: Batoclimab Maintenance Dose 1 (Period 2)Experimental Treatment1 Intervention

Group III: Batoclimab Induction Dose 2 (Period 1)Experimental Treatment1 Intervention

Group IV: Batoclimab Induction Dose 1 (Period 1)Experimental Treatment1 Intervention

Group V: Placebo Induction Dose (Period 1)Placebo Group1 Intervention

Group VI: Placebo Maintenance Dose (Period 2)Placebo Group1 Intervention

Batoclimab is already approved in European Union, United States for the following indications:

🇪🇺 Approved in European Union as Batoclimab for: