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

NCT04305197 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2022-11-30

No results posted yet for this study

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

Interventions

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

Sponsors & Collaborators

  • Beijing InnoCare Pharma Tech Co., Ltd.

    lead INDUSTRY

Principal Investigators

  • Zhanguo Li, MD/PhD · Peking University People's Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

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

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04305197 on ClinicalTrials.gov