A Study Assessing the Efficacy and Safety of SM03 in Patients With Active Rheumatoid Arthritis Receiving MTX

Phase 3 Unknown 510 enrolled SinoMab BioScience Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

* To demonstrate that SM03 added to methotrexate (MTX) reduce signs and symptoms of rheumatoid arthritis (RA) in Chinese RA participants with an inadequate response to MTX. * To assess the safety of SM03 added to MTX in Chinese RA participants with an inadequate response to MTX

Timeline

Start: 2017-12-28
Primary completion: 2021-12
Completion: 2022-07

Outcome

Met primary endpoint

release “SinoMab Announces that Phase III Clinical Trial of its Flagship Product SM03 (Suciraslimab) Achieved the Primary Endpoint for Rheumatoid Arthritis” sinomab.com ↗

Publications

Wong KL, Li Z, Ma F, Wang D, Song N, Chong CH, Luk KK, Leung SO. SM03, an Anti-CD22 Antibody, Converts Cis-to-Trans Ligand Binding of CD22 against alpha2,6-Linked Sialic Acid Glycans and Immunomodulates Systemic Autoimmune Diseases. J Immunol. 2022 Jun 15;208(12):2726-2737. doi: 10.4049/jimmunol.2100820. Epub 2022 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SM03	Monoclonal antibody	600 mg	Intravenous
Background	MTX	Unknown	7.5 mg	Oral
Background	MTX	Unknown	20 mg	Oral