Systemic Lupus Erythematosus
Conditions
Keywords
Mild to Moderate
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)
Interventions
DRUGICP-022
Tablet, 50mg, once a day, oral, will be administered for 12 weeks in double-blind treatment period
DRUGPlacebos
Tablet, matched to ICP-022, once a day, oral, will be administered for 12 weeks in double-blind treatment period
Sponsors
Beijing InnoCare Pharma Tech Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
Inclusion criteria
1. Male or female subjects aged 18 to 75 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
1. Failure to comply with the requirements of the programme 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 Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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 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 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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 | 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 |
| Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 4 (SRI-4) | 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 | — |
| Changes from Baseline in total B cell counts | 12 Weeks | — |
| Ratio of Patients With Response Based on Systemic Lupus Erythematosus Responder Index 6 (SRI-6) | 12 Weeks | — |
| 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 | — |
Countries
China
Outcome results
None listed