A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

Phase 1/2 Completed 60 enrolled Beijing InnoCare Pharma Tech Co., Ltd.

RandomizedParallel-groupDouble-blindTreatment

Summary

The purpose of the study is to assess the Safety, Tolerability, PK/PD and preliminary Efficacy of ICP-022 in Subjects with Systemic Lupus Erythematosus (SLE)

Timeline

Start: 2020-07-09
Primary completion: 2022-04-28
Completion: 2022-04-28

Publications

Li R, Li X, Zhu X, Liu S, Zhang X, Xie C, Fu Z, Huang A, Sun L, Liu D, Zhao J, Wu L, Li Z. Orelabrutinib for systemic lupus erythematosus: A randomised, double-blind, placebo-controlled study. J Autoimmun. 2026 Jun;161:103578. doi: 10.1016/j.jaut.2026.103578. Epub 2026 May 29.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Orelabrutinib	Small molecule	50 mg	Oral
Subject	Orelabrutinib	Small molecule	80 mg	Oral
Subject	Orelabrutinib	Small molecule	100 mg	Oral

A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)

Summary

Timeline

Publications

Drugs

Indications