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Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus

NCT04582136 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 146

Last updated 2025-09-26

No results posted yet for this study

Summary

This is a multi-center, double-blinded, randomized, placebo-controlled, phase 3 study to evaluate the efficacy and safety of sirolimus administered in addition to standard therapy, in patients with active SLE disease.

Conditions

Interventions

DRUG

Sirolimus

In the double-blinded phase, sirolimus 1.5mg/day plus SOC is administered throughout 24 weeks; in the open-label extension period, patients who opt to participate continue on sirolimus 1.5mg/day plus SOC for an additional 24 weeks.

DRUG

Placebo

In the double-blinded phase, placebo plus SOC is administered throughout 24 weeks; in the open-label extension period, patients who opt to participate are switched to receive sirolimus 1.5mg/day plus SOC for an additional 24 weeks.

Sponsors & Collaborators

  • Beijing Municipal Science & Technology Commission

    collaborator OTHER

  • North China Pharmaceutical Group Corporation

    collaborator INDUSTRY

  • Chinese SLE Treatment And Research Group

    lead OTHER

Principal Investigators

  • Xiaofeng Zeng, MD · Chinese SLE Treatment and Registration Group

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2021-03-04
Primary Completion
2025-04-21
Completion
2026-01-31

Countries

  • China

Study Locations

More Related Trials

Entities

Drugs
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 NCT04582136 on ClinicalTrials.gov