drugset / Trial / NCT07447986

To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus

NCT07447986 ↗

Phase 2 Recruiting 120 enrolled Hangzhou Sumgen Biotech Co., Ltd.
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

EvaluationDrugModalityDoseRoute
Subject SG301 Monoclonal antibody — Subcutaneous