Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus

PHASE3Active, not recruitingINTERVENTIONAL
Enrollment

146

Participants

Timeline

Start Date

March 4, 2021

Primary Completion Date

April 21, 2025

Study Completion Date

January 31, 2026

Conditions
Systemic Lupus Erythematosus
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.

Trial Locations (6)

100053

Peking Union Medical College Hospital, Beijing

Unknown

Shenzhen People's Hospital, Shenzhen

The First Affiliated Hospital of Zhengzhou University, Zhengzhou

The Second Affiliated Hospital of Nanchang University, Nanchang

The First Hospital of China Medical University, Shenyang

First Affiliated Hospital of Kunming Medical University, Kunming

All Listed Sponsors
collaborator

Beijing Municipal Science & Technology Commission

OTHER

collaborator

North China Pharmaceutical Group Corporation

INDUSTRY

lead

Chinese SLE Treatment And Research Group

OTHER