NCT05403541

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

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

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 240 (estimated)
• Sponsor: Immunovant Sciences GmbH · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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 (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.

Conditions

• Generalized Myasthenia Gravis

Interventions

Type	Name	Description
DRUG	Batoclimab 680 mg SC weekly	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
DRUG	Batoclimab 340 mg SC weekly	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
DRUG	Matching Placebo SC	Placebo
DRUG	Batoclimab 340 mg SC bi-weekly	Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody

Timeline

• Start date: 2022-06-27
• Primary completion: 2025-01-10
• Completion: 2027-02-01
• First posted: 2022-06-03
• Last updated: 2026-03-25

Locations

93 sites across 16 countries: United States, Argentina, Brazil, Canada, Georgia, Germany, Hungary, Italy, Japan, Mexico, Poland, Romania, Serbia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study