drugset / Trial / NCT05306873

Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus

NCT05306873

RandomizedParallel-groupTriple-blindTreatment

Summary

The primary purpose of this study is to evaluate the potential effectiveness of 24 weeks of MMF within previously discovered immunologically defined subsets of SLE patients. Treatment effects will be evaluated within the individual immunologically-homogenous subsets defined at screening. This study will also explore and compare pre-randomization gene expression patterns among responders and non-responders to MMF and MMF plus voclosporin, use comprehensive immunophenotyping to study the immunologic changes that accompany treatment- induced disease improvement and to better understand immunologic changes associated with the loss of clinical response.

Timeline

Start
2022-11-30
Primary completion
2024-06-13
Completion
2024-07-11

Drugs

EvaluationDrugModalityDoseRoute
Subject Mycophenolate Mofetil Small molecule 1000 mg
Subject Voclosporin Other / unclassified 23.7 mg