The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of SCTC21C in participants with systemic lupus erythematosus
This study contains phase Ib and phase II studies. In phase Ib study, participants will be assigned to receive sequentially higher doses of SCTC21C to determine the recomended dose of SCTC21C for the randomized dose optimation-stage. In phase 2 study, 2 dose levels will be uased. A total of 120 participants will be randomized in a 1:1:1 ration to dose 1, dose 2 or placebo groups to better understand the exposure/efficacy/toxicity relationship.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
159
SCTC21C 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)
Time frame: From first dose to Week 48
Phase II: efficacy of SCTC21C
Percentage of participants who achiened an mSRI-4 response at W24
Time frame: Up to Week 24
dose escalation part#SRI4/5/6/7/8
percentage of participants who achieved SRI4/5/6/7/8 response at specified time
Time frame: up to Week 48
Dose- escalation # mSRI4/5/6/7/8
percentage of participants who achieved mSRI4/5/6/7/8 response at specified time
Time frame: up to Week 48
Dose-escalation part # BILAG
The BILAG improvement rate among participants with baseline BILAG score of A or B at specified time
Time frame: up to Week 48
Dose-escalation part # SLE flare
Time to first SLE flare
Time frame: Up to Week 48
Dose-escalation part # immunogenicity
Serum anti-SCTC21C antibody and anti-SCTC21C neutralization antibody levels
Time frame: up to Week 48
Dose-escalation part # SCTC21C
Serum SCTC21C levels at specified time
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: up to Week 48