Summary of Clinical Use

Batoclimab (HBM9161; IMVT-1401) was a clinical candidate for a range of autoimmune conditions. Despite meeting the primary endpoint in a phase 3 myasthenia gravis trial, the developer (Immunovant) chose to cease development of batoclimab, instead replacing it with a second generation anti-FcRn option (IMVT-1402) as lead asset.

Clinical Trials
Clinical Trial ID	Title	Type	Source	Comment	References
NCT05581199	To Assess Efficacy and Safety of Batoclimab in Adult Participants With Active CIDP	Phase 2 Interventional	Immunovant Sciences GmbH
NCT05524571	Study to Assess Batoclimab in Participants With Active Thyroid Eye Disease	Phase 3 Interventional	Immunovant Sciences GmbH
NCT05403541	Phase 3 Study to Assess the Efficacy and Safety of Batoclimab as Induction and Maintenance Therapy in Adult Participants With Generalized Myasthenia Gravis	Phase 3 Interventional	Immunovant Sciences GmbH
NCT05039190	Evaluate the Efficacy and Safety of HBM9161(HL161)Subcutaneous Injection in Patients With Generalized MG Patients	Phase 3 Interventional	Harbour BioMed (Guangzhou) Co. Ltd.
NCT04428255	A Clinical Study on the Efficacy and Safety of HBM9161 in Patients With ITP	Phase 2/Phase 3 Interventional	Harbour BioMed (Guangzhou) Co. Ltd.
NCT03971916	A Phase I Study Evaluating the Safety, Tolerability, PK and PD in Healthy Chinese Volunteers	Phase 1 Interventional	Harbour BioMed (Guangzhou) Co. Ltd.		1
NCT05517447	Extension Study to Assess Batoclimab in Participants With Thyroid Eye Disease	Phase 3 Interventional	Immunovant Sciences GmbH