A Study of SYS6020 Injection in Refractory Active Systemic Lupus Erythematosus
Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-70
SponsorCSPC ZhongQi Pharmaceutical Technology Co., Ltd.
About this trial
This study aimed to observe the safety and tolerability of SYS6020 in adult participants with refractory active systemic lupus erythematosus, determine the recommended dose (RD) that may be explored for subsequent studies, and preliminly evaluate the clinical efficacy of this product,and explore the pharmacokinetics and immunogenicity of SYS6020 injection in those participants.
Eligibility criteria
Qualifiers
1. Age ≥18 years old, ≤70 years old;
2. SLE is diagnosed according to SLICC 2012 or EULAR/ACR 2019 revised criteria.
3. Patients are required to have received glucocorticoid combined with immunosuppressive agents and/or biological agents for more than 3 months, with a stable dose for more than 2 weeks, and the disease is still in an active state.
4. Antinuclear antibody, anti-ds-DNA antibody and/or anti-Smith antibody are positive.
Disqualifiers
1. Severe lupus nephritis within 8 weeks before screening;
2. SLE or non-SLE-related central nervous system disease or lesion within 8 weeks before screening;
3. uncontrolled lupus crisis within 8 weeks before screening;
4. clinically significant central nervous system diseases or pathological changes other than lupus before screening;
Trial design
Treatments tested in this trial
- SYS6020
Treatment groups
50 Participants
are divided into 1 treatment groupLocations
Sponsors and collaborators
Source ClinicalTrials.gov