MedTrace Logo

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

NCT07447986 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2026-04-02

No results posted yet for this study

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 .

Conditions

  • Systemic Lupus Erythematosus (SLE)

Interventions

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.

Sponsors & Collaborators

  • Hangzhou Sumgen Biotech Co., Ltd.

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-26
Primary Completion
2027-09-30
Completion
2027-12-31

Countries

  • China

Study Locations

More Related Trials

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07447986 on ClinicalTrials.gov