drugset / Trial / NCT07447986
To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
RandomizedParallel-groupTriple-blindTreatment
Summary
This was a multicenter, randomized, double-blind, placebo-controlled Phase 2 clinical study. The primary objective was to evaluate the efficacy of SG301 SC injection in participants with Systemic Lupus Erythematosus (SLE) based on the Systemic Lupus Erythematosus Responder Index -4 (SRI-4) response rate. The secondary objectives were to assess the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants .
Timeline
- Start
- 2026-03-26
- Primary completion
- 2027-09-30
- Completion
- 2027-12-31
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | SG301 | Monoclonal antibody | — | Subcutaneous |