NCT04736953

Sirolimus Treatment Of Patients With SLE

Sirolimus Treatment of Patients With Systemic Lupus Erythematosus

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 220 (estimated)
• Sponsor: State University of New York - Upstate Medical University · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Lupus Erythematosus, Systemic

Interventions

Type	Name	Description
DRUG	Sirolimus	Sirolimus
OTHER	Placebo	Placebo

Timeline

• Start date: 2025-01-01
• Primary completion: 2029-01-01
• Completion: 2029-01-01
• First posted: 2021-02-03
• Last updated: 2023-06-05

Regulatory

• FDA-regulated drug study