Examining Distinct Immunophenotypes to Validate and Enhance Rational Treatment in Systemic Lupus
Public ClinicalTrials.gov record NCT05306873. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
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)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05306873
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 12 participants
Conditions and interventions
Conditions
Interventions
- Mycophenolate Mofetil Drug
- Placebo for Mycophenolate Mofetil Drug
- Voclosporin Drug
- Placebo for Voclosporin Drug
Drug
Eligibility (public fields only)
- Age range
- 18 Years to 60 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 30, 2022 (Actual)
- Primary completion
- Jun 13, 2024 (Actual)
- Completion
- Jul 11, 2024 (Actual)
- Last update posted
- Sep 9, 2025
2022 – 2024
United States locations
- U.S. sites
- 10
- U.S. states
- 8
- U.S. cities
- 9
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| UCLA Medical Center: Division of Rheumatology | Los Angeles | California | 90095 | — |
| Yale University School of Medicine: Rheumatology, Allergy & Immunology | New Haven | Connecticut | 06519 | — |
| Emory University School of Medicine: Division of Rheumatology | Atlanta | Georgia | 30307 | — |
| Piedmont Healthcare: Rheumatology Atlanta | Atlanta | Georgia | 30318 | — |
| Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases | Boston | Massachusetts | 02114 | — |
| Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases | Manhasset | New York | 11030 | — |
| Columbia University Medical Center: Department of Medicine, Division of Rheumatology | New York | New York | 10032 | — |
| University of North Carolina at Chapel Hill; Thurston Arthritis Research Center: Division of Rheumatology, Allergy, and Immunology | Chapel Hill | North Carolina | 27599 | — |
| Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program | Oklahoma City | Oklahoma | 73104 | — |
| PennState Health Milton S. Hershey Medical Center: Division of Rheumatology | Hershey | Pennsylvania | 17033 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05306873, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Sep 9, 2025 · Synced Oct 20, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05306873 live on ClinicalTrials.gov.