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Safety and Efficacy of SM934 Compared to Placebo in Adult Subjects With Active Systemic Lupus Erythematosus

NCT03951259 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 32

Last updated 2023-10-27

No results posted yet for this study

Summary

This is a single-center, randomized, double-blind, placebo-controlled, phase 2 study. The purpose of the study is to initially evaluate the safety and efficacy of SM934 combined with steroids compared to placebo in adult subjects with active systemic lupus erythematosus (SLE) over a 12-week period.

Conditions

Interventions

DRUG

SM934

In this study, the investigating intervention is oral administration of SM934. SM934 is a water-soluble derivative of arteminisin, which exerts immunosuppressive functions in vitro and in vivo.

DRUG

Placebos

The placebo pills are made identical to the investigating SM934 in appearance.

Sponsors & Collaborators

  • Jiangsu ZuoYou Medicine Co., Ltd.

    collaborator UNKNOWN

  • RenJi Hospital

    lead OTHER

Principal Investigators

  • Nan Shen, MD & PhD · Shanghai Jiao Tong University School of Medicine affiliated Renji Hospital

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2019-07-24
Primary Completion
2023-10-13
Completion
2023-10-19

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

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 NCT03951259 on ClinicalTrials.gov