Sirolimus Treatment Of Patients With SLE

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.

NCT Number	NCT04736953
Lead Sponsor	State University of New York - Upstate Medical University
Conditions	Lupus Erythematosus, Systemic
Enrollment	220 participants
Start Date	2025-01-01
Primary Completion	2029-01-01 (estimated)
Study Completion	2029-01-01 (estimated)
Updated on ClinicalTrials.gov	2023-06-05