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

Systemic Lupus Erythematosus Clinical Trial

Official title:
A Phase 2, Double-Blind, Placebo-Controlled Trial of Mycophenolate Mofetil Alone or With Voclosporin for Systemic Lupus: Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment (DIVERT) (ALE10)

Clinical Trial 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.

Clinical Trial Description

n/a

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT05306873
Study type Interventional
Source National Institute of Allergy and Infectious Diseases (NIAID)
Contact
Status Recruiting
Phase Phase 2
Start date October 28, 2022
Completion date June 20, 2026
View Details
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