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

NCT05306873 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 12

Last updated 2025-09-09

Study results available
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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.

Conditions

Interventions

DRUG

Mycophenolate Mofetil

Stage 2 Dosing: Week 1: Participants will receive 500mg MMF/Placebo twice daily Week 2: Participants will receive 500mg/Placebo in the morning and 1,000mg MMF/Placebo in the evening Weeks 3-48: Participants will receive 1000mg MMF/Placebo twice daily

DRUG

Placebo for Mycophenolate Mofetil

Stage 2 Dosing: Week 1: Participants will receive 500mg MMF/Placebo twice daily Week 2: Participants will receive 500mg/Placebo in the morning and 1,000mg MMF/Placebo in the evening Weeks 3-48: Participants will receive 1000mg MMF/Placebo twice daily

DRUG

Voclosporin

Weeks 1-24: 23.7 mg Voclosporin (3 x 7.9 capsules) twice daily

DRUG

Placebo for Voclosporin

Weeks 1-24: 23.7 mg Placebo for Voclosporin (3 x 7.9 capsules) twice daily

DRUG

Mycophenolate Mofetil

Stage 3 Dosing: Participants who received placebo MMF in Stage 2: * Week 1: Participants will receive 500mg MMF plus matching placebo for MMF (to appear like a 1000mg dose) twice daily * Week 2: Participants will receive 500mg plus matching placebo for MMF (to appear like a 1000mg dose) and 1000mg in divided doses * Weeks 3-24: 1000mg MMF twice daily Participants who received MMF in Stage 2 • Week 1-24: 1000mg MMF twice daily

Sponsors & Collaborators

  • National Institute of Allergy and Infectious Diseases (NIAID)

    lead NIH

Principal Investigators

  • Joan Merrill, M.D. · Oklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-30
Primary Completion
2024-06-13
Completion
2024-07-11
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05306873 on ClinicalTrials.gov