A Study of ICP-022 in Patients With Systemic Lupus Erythematosus (SLE)
- Registration Number
- NCT04305197
- Lead Sponsor
- Beijing InnoCare Pharma Tech Co., Ltd.
- Brief 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)
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 60
- Male or female subjects aged 18 to 75
- diagnosis of with SLE at least 6 months at screening visit
- SLEDAE-2K≥5
- Is receiving standard treatment for SLE and has been receiving treatment for at least 3 months.
- At least one SLE activity manifestation (as assessed by SLEDAE-2K)
- Failure to comply with the requirements of the programme
- A female or male partner who is pregnant or breastfeeding or who plans to become pregnant during the study period
- Previously treated with a BTK inhibitor
- Neuropsychiatric lupus (NPSLE)
- Has other autoimmune diseases other than SLE
Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Lower Dose ICP-022 - Medium Dose ICP-022 - Higher Dose ICP-022 - Placebo Placebos -
- Primary Outcome Measures
Name Time Method 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 participants with clinically significant physical examination 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 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 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
- Secondary Outcome Measures
Name Time Method Serum Immunoglobulin (Ig) level 12 Weeks 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 Changes from Baseline in C4 12 Weeks Changes from Baseline in Anti-nuclear Antibodies 12 Weeks Occupancy rate of Bruton Tyrosine Kinase(BTK) 14 Days Changes from Baseline in C3 12 Weeks Changes from Baseline in serum dsDNA 12 Weeks Changes from Baseline in Interferon-α(INF-α) level 12 Weeks Changes from Baseline in cytokine levels
Changes from Baseline in Interleukin-6(IL-6) level 12 Weeks Changes from Baseline in cytokine levels
Changes from Baseline in Ig 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
Trial Locations
- Locations (11)
The First Affiliated Hospital of Bengbu Medical College
🇨🇳Bengbu, Anhui, China
Peking University People's Hospital
🇨🇳Beijing, Beijing, China
Peking University third hospital
🇨🇳Beijing, Beijing, China
Shenzhen People's Hospital
🇨🇳Shenzhen, Guangdong, China
First Affiliated Hospital of Zhengzhou University
🇨🇳Zhengzhou, Henan, China
Gulou Hospital Affiliated to Medical College of Nanjing University
🇨🇳Nanjing, Jiangsu, China
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
🇨🇳Wuhan, Hubei, China
Huashan Hospital affiliated to Fudan University
🇨🇳Shanghai, Shanghai, China
The First Affiliated Hospital of Shanxi Medical University
🇨🇳Taiyuan, Shanxi, China
Guangdong General Hospital
🇨🇳Guangzhou, Guangdong, China
University of Hong Kong Shenzhen Hospital
🇨🇳Shenzhen, Guangdong, China