NCT04305197

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

A Phase Ib/IIa Double-blind, Randomized, Placebo-controlled Study to Evaluate the Safety, Tolerance, Pharmacokinetics/ Pharmacodynamics(PK/PD) of ICP-022 in Patients With Mild and Moderate Systemic Lupus Erythematosus

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 60 (actual)
• Sponsor: Beijing InnoCare Pharma Tech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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)

Conditions

• Systemic Lupus Erythematosus

Interventions

Type	Name	Description
DRUG	ICP-022	Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
DRUG	ICP-022	Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
DRUG	ICP-022	Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
DRUG	Placebos	Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Timeline

• Start date: 2020-07-09
• Primary completion: 2022-04-28
• Completion: 2022-04-28
• First posted: 2020-03-12
• Last updated: 2022-11-30

Locations

11 sites across 1 country: China