The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus
Aged 18-75 years;
Diagnosed with SLE for ≥12 weeks prior to screening, met the 2019 ACR/EULAR diagnostic criteria for SLE screening period;
SELENA-SLEDAI ≥8 at screening;
Positive immunological markers within 12 months prior to baseline;
Severe active or unstable lupus-related neuropsychiatric disorders;
Combined with active infections, malignant tumors, or other autoimmune diseases;
Catastrophic antiphospholipid syndrome;
severe lupus nephritis;
Single group
SCTC21C
Biological/VaccineSCTC21C will be subcutaneously administered at a dose as specified in the respective dose-escalation cohorts. Then, the RP2D and other appropriate doses of SCTC21C will be applied for the dose-expansion cohorts
Phase 1: safety and tolerability of SCTC21C
To evaluate the incidence rates of treatment emergent adverse event (TEAE), treatment-related TEAE (TRAE), serious adverse event (SAE) and dose-limiting toxicity (DLT)
Phase II: efficacy of SCTC21C
Percentage of participants who achiened an mSRI-4 response at W24
dose escalation part#SRI4/5/6/7/8
percentage of participants who achieved SRI4/5/6/7/8 response at specified time
Dose- escalation # mSRI4/5/6/7/8
percentage of participants who achieved mSRI4/5/6/7/8 response at specified time
Dose-escalation part # BILAG
The BILAG improvement rate among participants with baseline BILAG score of A or B at specified time
Dose-escalation part # SLE flare
Time to first SLE flare
Click on the lead sponsor to view all of their trials.
This trial is not recruiting at the moment. You can still explore other options:
