CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 60 enrolled
Drug / intervention
ICP-022 +3 moredrug
Likely dose
ICP-022 50mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04305197
NCT04305197Phase 2Completed
CompareCT.gov

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

Beijing InnoCare Pharma Tech Co., Ltd.·interventional·Posted Mar 12, 2020·Updated Nov 30, 2022

In Brief

A Phase 2 clinical trial evaluating ICP-022 and Placebos for Systemic Lupus Erythematosus. Completed, enrolled 60 participants across 11 sites.

Detailed 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)

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsSystemic Lupus Erythematosus
CountriesChina
Collaborators--

Timeline

Phase 2CompletedFinished
202120222023202420252026
First PostedMar 12, 2020
Enrollment StartJul 9, 2020
Primary CompletionApr 28, 2022
TodayJul 2, 2026
Enrollment to primary: 1.8 yearsPosted 6.3 years ago

Interventions

ICP-022drug

Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

ICP-022drug

Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

ICP-022drug

Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period

Placebosdrug

Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period