A Study to Evaluate the Safety and Efficacy of SM03 in Patients With Rheumatoid Arthritis Receiving Methotrexate

NCT04192617 ↗

Phase 2 Completed 156 enrolled SinoMab BioScience Ltd

RandomizedParallel-groupQuadruple-blindTreatment

Summary

This study evaluated the safety and efficacy of SM03 compared to placebo in patients with active rheumatoid arthritis(RA) receiving methotrexate

Timeline

Start: 2014-12-31
Primary completion: 2016-02-03
Completion: 2016-02-03

Outcome

Met primary endpoint

paper The 24-week ACR20 response rate was significantly higher with high- (65.3%, P = 0.002) and low-dose SM03 (56.9%, P = 0.024) than with placebo (34.0%), PMID 34508557 ↗

Publications

Li J, Li M, Wu D, Zhou J, Leung SO, Zhang F. SM03, an anti-human CD22 monoclonal antibody, for active rheumatoid arthritis: a phase II, randomized, double-blind, placebo-controlled study. Rheumatology (Oxford). 2022 May 5;61(5):1841-1848. doi: 10.1093/rheumatology/keab699.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	SM03	Monoclonal antibody	600 mg	Intravenous
Background	Methotrexate	Small molecule	7.5 mg	Oral
Background	Methotrexate	Small molecule	20 mg	Oral