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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
60
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Tablet, 80mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Tablet, 100mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
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
Number of participants that experience Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Up to 28 Days after the last dose of study drug
Number of Patients with Treatment-emergent Adverse Event(TEAEs) according to severity
Time frame: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant physical examination abnormalities
Time frame: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant vital signs abnormalities
Time frame: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant ECG abnormalities
Time frame: Up to 28 Days after the last dose of study drug
Number of participants with clinically significant laboratory examination abnormalities
Time frame: Up to 28 Days after the last dose of study drug
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4)
Time frame: 12 Weeks
Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6)
Time frame: 12 Weeks
Occupancy rate of Bruton Tyrosine Kinase(BTK)
Time frame: 14 Days
Serum Immunoglobulin (Ig) level
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
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
...and 1 more locations
Time frame: 12 Weeks
Changes from Baseline in Ig levels
Time frame: 12 Weeks
Changes from Baseline in C3
Time frame: 12 Weeks
Changes from Baseline in C4
Time frame: 12 Weeks
Changes from Baseline in serum dsDNA
Time frame: 12 Weeks
Changes from Baseline in Anti-nuclear Antibodies
Time frame: 12 Weeks
Changes from Baseline in Interferon-α(INF-α) level
Changes from Baseline in cytokine levels
Time frame: 12 Weeks
Changes from Baseline in Interleukin-6(IL-6) level
Changes from Baseline in cytokine levels
Time frame: 12 Weeks
Changes from Baseline in total B cell counts
Time frame: 12 Weeks
Change from Baseline in Beffs count
Time frame: 12 Weeks
Changes from baseline in Bregs count
Time frame: 12 Weeks
Changes from Baseline in Bregs to Beffs ratio
Time frame: 12 Weeks
Changes from Baseline in Erythrocyte Sedimentation Rate(ESR)
Time frame: 12 Weeks
The plasma concentration-time curve
Time frame: 14 Days