Clinical Trial

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

Recruiting Phase 2
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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 .
Protocol Amendment History 1 change
critical Recruitment opened 2026-04-03
Trial Details
NCT Number NCT07447986
Lead Sponsor Hangzhou Sumgen Biotech Co., Ltd.
Conditions Systemic Lupus Erythematosus (SLE)
Enrollment 120 participants
Start Date 2026-03-26
Primary Completion 2027-09-30 (estimated)
Study Completion 2027-12-31 (estimated)
Updated on ClinicalTrials.gov 2026-04-02