NCT07447986

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

• Status: Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 120 (estimated)
• Sponsor: Hangzhou Sumgen Biotech Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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 .

Detailed description

This was a multicenter, randomized, double-blind, placebo-controlled Phase II clinical study. The primary objective was to evaluate the efficacy of SG301 SC Injection in participants with systemic lupus erythematosus (SLE) as assessed by the SRI-4 score. The secondary objectives included assessing the safety, pharmacokinetics, pharmacodynamics, and immunogenicity profiles of SG301 SC injection in these participants. Eligible participants were those diagnosed with SLE in accordance with the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) classification criteria, with a Systemic Lupus Erythematosus Disease Activity Index - 2000 (SLEDAI-2K )score of ≥ 8 points and seropositivity for antinuclear antibody (ANA) or anti-double-stranded DNA (anti-dsDNA) antibody at the screening visit.

Conditions

• Systemic Lupus Erythematosus (SLE)

Interventions

Type	Name	Description
DRUG	SG301 SC Injection	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.
DRUG	SG301 SC Injection	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
DRUG	SG301 SC placebo	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.

Timeline

• Start date: 2026-03-26
• Primary completion: 2027-09-30
• Completion: 2027-12-31
• First posted: 2026-03-04
• Last updated: 2026-04-02

Locations

1 site across 1 country: China