Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus (SiroLupus)
Efficacy and Safety of Sirolimus in Active Systemic Lupus Erythematosus (SiroLupus)
Brief Summary:
This is a multi-center, double-blinded, randomized, placebo-controlled, phase 2 study to evaluate the efficacy and safety of sirolimus administered in addition to standard therapy, in patients with active SLE disease.
Detailed Description:
This study is a multi-center, double-blinded, randomized, placebo-controlled, phase 2 clinical trial to assess the safety and efficacy of sirolimus in patients with active systemic lupus erythematosus despite receiving standard background therapy.
Six large rheumatological referring centers across from China will participate in the study.
The study is divided into two phases. The first phase is a 24-week randomized, double-blinded, placebo-controlled trial, from which the primary end point will be generated, and the second phase is a 24-week open-labeled extension trial.
The study enrolls SLE patients between 18~65 years old who have SLEDAI-2K score ≥4 (not including scores for anti-dsDNA antibody and hypocomplementemia), despite conventional treatment (e.g., immunosuppressants, antimalarial drugs, glucocorticoids, NSAIDs, anti-hypertensive drugs, and/or topical medications). In addition, subjects must be serologically active (positive anti-dsDNA antibody and/or hypocomplementemia.
Subjects will be randomly assigned by 1:1 ratio to receive sirolimus (1.5mg/day) or placebo for the first 24-week phase. In the second 24-week open-labeled phase, sirolimus patients receive the same dose of sirolimus, and placebo group are switched to receive sirolimus at 1.5mg/day.
Study Type: Interventional (Clinical Trial)
Estimated Enrollment: 146 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Efficacy and Safety of Sirolimus in Patients With Active Systemic Lupus Erythematosus Despite Standard of Care: a Multi-center, Double Blinded, Randomized, Placebo-controlled, Phase 2 Trial
Estimated Study Start Date: November 2020
Estimated Primary Completion Date: November 2021
Estimated Study Completion Date: November 2022
Arm:
- Experimental: Sirolimus plus SOC
- Placebo Comparator: Placebo plus SOC
| Category | Value |
|---|---|
| Study type(s) | Interventional |
| Expected enrolment | 146 |
| Estimated Study start date | 01 November 2020 |
| Estimated Study Completion Date | 01 November 2022 |