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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)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lower Dose | Experimental |
| |
| Medium Dose | Experimental |
| |
| Higher Dose | Experimental |
| |
| Placebo | Placebo Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| ICP-022 | Drug | Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs) | Up to 28 Days after the last dose of study drug | |
| Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity | Up to 28 Days after the last dose of study drug | |
| Number of participants with clinically significant physical examination abnormalities | Up to 28 Days after the last dose of study drug | |
| Number of participants with clinically significant vital signs abnormalities | Up to 28 Days after the last dose of study drug | |
| Number of participants with clinically significant ECG abnormalities | Up to 28 Days after the last dose of study drug | |
| Number of participants with clinically significant laboratory examination abnormalities | Up to 28 Days after the last dose of study drug |
| Measure | Description | Time Frame |
|---|---|---|
| Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) | 12 Weeks | |
| Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) | 12 Weeks |
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Inclusion Criteria:
Exclusion Criteria:
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
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| Name | Affiliation | Role |
|---|---|---|
| Zhanguo Li, MD/PhD | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Bengbu Medical College | Bengbu | Anhui | China | |||
| Peking University People's Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 42214214 | Derived | 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. |
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| ID | Term |
|---|---|
| D008180 | Lupus Erythematosus, Systemic |
| ID | Term |
|---|---|
| D003240 | Connective Tissue Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| C000729508 | orelabrutinib |
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| ICP-022 | Drug | Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period |
|
|
| ICP-022 | Drug | Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period |
|
|
| Placebos | Drug | Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period |
|
| Occupancy rate of Bruton Tyrosine Kinase(BTK) | 14 Days |
| Serum Immunoglobulin (Ig) level | 12 Weeks |
| Changes from Baseline in Ig levels | 12 Weeks |
| Changes from Baseline in C3 | 12 Weeks |
| Changes from Baseline in C4 | 12 Weeks |
| Changes from Baseline in serum dsDNA | 12 Weeks |
| Changes from Baseline in Anti-nuclear Antibodies | 12 Weeks |
| Changes from Baseline in Interferon-α(INF-α) level | Changes from Baseline in cytokine levels | 12 Weeks |
| Changes from Baseline in Interleukin-6(IL-6) level | Changes from Baseline in cytokine levels | 12 Weeks |
| Changes from Baseline in total B cell counts | 12 Weeks |
| Change from Baseline in Beffs count | 12 Weeks |
| Changes from baseline in Bregs count | 12 Weeks |
| Changes from Baseline in Bregs to Beffs ratio | 12 Weeks |
| Changes from Baseline in Erythrocyte Sedimentation Rate(ESR) | 12 Weeks |
| The plasma concentration-time curve | 14 Days |
| Beijing |
| Beijing Municipality |
| 100000 |
| China |
| Peking University third hospital | Beijing | Beijing Municipality | 100000 | 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 | 210000 | China |
| Huashan Hospital affiliated to Fudan University | Shanghai | Shanghai Municipality | China |
| The First Affiliated Hospital of Shanxi Medical University | Taiyuan | Shanxi | China |