A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
NCT ID: NCT04305197
Last Updated: 2022-11-30
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
PHASE1/PHASE2
60 participants
INTERVENTIONAL
2020-07-09
2022-04-28
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Lower Dose
ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Medium Dose
ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Higher Dose
ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Placebo
Placebos
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Interventions
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ICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
ICP-022
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
ICP-022
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Placebos
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
2. diagnosis of with SLE at least 6 months at screening visit
3. SLEDAE-2K≥5
4. Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
5. At least one SLE activity manifestation (as assessed by SLEDAE-2K)
Exclusion Criteria
2. A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
3. Previously treated with a BTK inhibitor
4. Neuropsychiatric lupus (NPSLE)
5. Has other autoimmune diseases other than SLE
18 Years
75 Years
ALL
No
Sponsors
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Beijing InnoCare Pharma Tech Co., Ltd.
INDUSTRY
Responsible Party
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Principal Investigators
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Zhanguo Li, MD/PhD
Role: PRINCIPAL_INVESTIGATOR
Peking University People's Hospital
Locations
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The First Affiliated Hospital of Bengbu Medical College
Bengbu, Anhui, China
Peking University People's Hospital
Beijing, Beijing Municipality, China
Peking University third hospital
Beijing, Beijing Municipality, China
Guangdong General Hospital
Guangzhou, Guangdong, China
Shenzhen People's Hospital
Shenzhen, Guangdong, China
University of Hong Kong Shenzhen Hospital
Shenzhen, Guangdong, China
First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Wuhan, Hubei, China
Gulou Hospital Affiliated to Medical College of Nanjing University
Nanjing, Jiangsu, China
Huashan Hospital affiliated to Fudan University
Shanghai, Shanghai Municipality, China
The First Affiliated Hospital of Shanxi Medical University
Taiyuan, Shanxi, China
Countries
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Other Identifiers
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ICP-CL-00109
Identifier Type: -
Identifier Source: org_study_id
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