Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:34 AM
Ignite Modification Date:
2025-12-25 @ 12:34 AM
NCT ID:
NCT04643067
Eligibility Criteria:
Inclusion criteria are listed as follows:
1. Age≥18
2. BMI between 18-40kg/m²
3. Diagnosed with SLE according to the 2019 EULAR/ACR criteria for SLE
4. Meeting SLE activity requirements
5. Males and females childbearing potential must agree to use contraception methods
6. All patients must:
1. Understand that KPG-818 could have potential teratogenic risk.
2. Agree not to share KPG-818 with another person.
3. Be counseled about pregnancy precautions and risks of fetal exposure as described in the Pregnancy Prevention Plan.
7. Patients must agree not to donate blood (or any component of blood) from 3 months before Screening until 3 months after the last dose of KPG-818.
8. Patients must be willing to comply with precautions to reduce the risk of COVID-19 infection and to undergo COVID-19 PCR test.
Exclusion criteria are listed as follows:
1. Use of any prohibited medications within the pre-specified time
2. Patients must meet exclusionary lab criteria
3. Active and/or unstable neuropsychiatric SLE
4. Active or history of severe systemic bacterial, viral, fungal, mycobacterial, or parasitic infections within 6 months prior to Screening
5. Current or recent sign or symptoms of infections, or severe viral infections
6. Conditions predisposes patient to infection
7. Active TB or positive QuantiFERON®-TB Gold test
8. Patients with malignancy and antiphospholipid syndrome history
9. Inflammatory joint or skin disease, mixed connective tissue disease, scleroderma, and/or overlap syndromes, or acute or chronic disease
10. Concomitant condition that required systemic corticosteroid use within 1 year before Screening
11. Alcohol or drug abuse history
12. Positive urine drug test at screening
13. History or planned major surgery
14. Pregnant or breastfeeding female
15. Signs or symptoms of COVID-19 infection
16. Known allergic reaction to any of the ingredients for study drug or placebo
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04643067
Study Brief:
Protocol Section:
NCT04643067