Clinical trialNCT05306873TerminatedPhase 2Interventional

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

SponsorNational Institute of Allergy and Infectious Diseases (NIAID)Enrollment12Systemic Lupus Erythematosus

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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.

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Investigators

The overall officials registered on this study. Names that resolve to a findmyKOL profile link to it; the rest are shown as registered.

Joan Merrill, M.D.
Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program
Study ChairKOL profile →
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

10 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Ucla Medical Center: Division of Rheumatology
Los Angeles, California, United States
Yale University School of Medicine: Rheumatology, Allergy & Immunology
New Haven, Connecticut, United States
Emory University School of Medicine: Division of Rheumatology
Atlanta, Georgia, United States
Piedmont Healthcare: Rheumatology Atlanta
Atlanta, Georgia, United States
Massachusetts General Hospital: Rheumatology, Allergy and Immunology, Center for Immunology and Inflammatory Diseases
Boston, Massachusetts, United States
Feinstein Institute for Medical Research: Center for Autoimmune and Musculoskeletal Diseases
Manhasset, New York, United States
Columbia University Medical Center: Department of Medicine, Division of Rheumatology
New York, New York, United States
University of North Carolina at Chapel Hill; Thurston Arthritis Research Center: Division of Rheumatology, Allergy, and Immunology
Chapel Hill, North Carolina, United States
Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program
Oklahoma City, Oklahoma, United States
Pennstate Health Milton S. Hershey Medical Center: Division of Rheumatology
Hershey, Pennsylvania, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

Mycophenolate mofetil →Placebo for Mycophenolate MofetilPlacebo for VoclosporinVoclosporin →

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 30 Nov 2022
Primary completion: 13 Jun 2024
Completion: 11 Jul 2024
Last update posted: 9 Sept 2025
Registered enrollment: 12
Registry id: NCT05306873

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 24 Aug 2026. Registry facts are shown as registered by the study sponsor; findmyKOL does not interpret them.