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Sirolimus Treatment Of Patients With SLE — STOPSLE  

Lupus Erythematosus, Systemic Clinical Trial

Official title:
Sirolimus Treatment of Patients With Systemic Lupus Erythematosus

Clinical Trial Summary

Phase II Double-blind, placebo-controlled, randomized treatment trial with two arms: one SIROLIMUS arm with 92 patients and one placebo arm with 92 patients. The safety and therapeutic efficacy of SIROLIMUS will be determined within a dosage range of 1 mg/day to 4 mg/day, which will be titrated to tolerance during an initial 3-month open label period, relative to placebo in SLE patients over 12 months followed by a 1-month washout. The proposed study design, known as an enriched enrollment randomized withdrawal (EERW), has major advantages that (1) only people who tolerate SIROLIMUS are randomized, potentially reducing the percentage of dropouts in the randomized phase and (2) it allows participants to use an individualized dosage of study medication, which mimics clinical practice in terms of how SIROLIMUS would be administered. Healthy subjects receive no drugs and serve as controls for in vitro studies.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04736953
Study type Interventional
Source State University of New York - Upstate Medical University
Contact
Status Not yet recruiting
Phase Phase 2
Start date January 1, 2025
Completion date January 1, 2029
View Details
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