To Evaluate the Efficacy and Safety of SG301 SC Injection in Systemic Lupus Erythematosus
A Randomized, Double-Blind, Placebo-Controlled Phase 2 Clinical Study to Evaluate the Efficacy and Safety of SG301 SC Injection in Patients With Systemic Lupus Erythematosus
Hangzhou Sumgen Biotech Co., Ltd.
120 participants
Mar 26, 2026
INTERVENTIONAL
Conditions
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 .
Eligibility
Plain Language Summary
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Interventions
One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.
One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered, among which 2 injections are placebos
One injection per week for 8 doses, followed by one injection every two weeks for another 8 doses, with a total of 16 injections administered.
Locations(1)
View Full Details on ClinicalTrials.gov
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NCT07447986