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

Conditions

• Systemic Lupus Erythematosus

Eligibility Criteria

Sex

ALL

Age

18 Years - 60 Years

Healthy Volunteers

Not accepted

Interventions

• Mycophenolate Mofetil — DRUG
  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
• Placebo for Mycophenolate Mofetil — DRUG
  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
• Voclosporin — DRUG
  Weeks 1-24: 23.7 mg Voclosporin (3 x 7.9 capsules) twice daily
• Placebo for Voclosporin — DRUG
  Weeks 1-24: 23.7 mg Placebo for Voclosporin (3 x 7.9 capsules) twice daily
• Mycophenolate Mofetil — DRUG
  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

Study Details

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.

Key Dates

Start date

Nov 30, 2022

Status verified

Sep 2025

Primary completion

Jun 13, 2024

Completion

Jul 11, 2024

Study Design

Enrollment

12 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: MMF
  Participants will receive 500 mg mycophenolate mofetil (MMF) bid for 7 days, followed by 500mg and 1,000mg MMF in divided doses for 7 days. They will then continue at a stable dose of 1,000mg MMF bid. Visits to evaluate AEs, vital signs, hematology and chemistry, study medication compliance, medication use, disease status, participant reported outcomes, and to obtain biomarker samples will occur every 4 weeks after randomization
• Placebo Comparator: Placebo for MMF
  Participants will receive 500 mg corresponding mycophenolate mofetil (MMF) placebo bid for 7 days, followed by 500mg and 1,000mg corresponding MMF placebo in divided doses for 7 days. They will then continue at a stable dose of 1,000mg corresponding MMF placebo bid. Visits to evaluate AEs, vital signs, hematology and chemistry, study medication compliance, medication use, disease status, participant reported outcomes, and to obtain biomarker samples will occur every 4 weeks after randomization
• Experimental: MMF+ Placebo for Voclosporin
  Participants randomized in this arm will receive up to 24 weeks of mycophenolate mofetil (MMF) plus placebo for voclosporin, also during the first 2 weeks of treatment, a single intramuscular injection of a long-acting corticosteroid may be administered if needed to achieve amelioration of symptoms without meeting the definition of treatment failure in Stage 3 and without a requirement to stop Stage 3 study-provided medication
• Experimental: MMF+ Voclosporin
  Participants randomized in this arm will receive up to 24 weeks of mycophenolate mofetil (MMF) plus voclosporin, also during the first 2 weeks of treatment, a single intramuscular injection of a long-acting corticosteroid may be administered if needed to achieve amelioration of symptoms without meeting the definition of treatment failure in Stage 3 and without a requirement to stop Stage 3 study-provided medication

Primary Outcome Measure

The Percentage of Participants Who Experience a Stage 2 Treatment Failure at or Before the Stage 2 Week 24 Visit. [ Time Frame: From Baseline to Stage 2 Week 24 ]

Locations (10)

Related coverage on Hipa.ai

• Voclosporin: Phase 2 Systemic Lupus trial shows fewer treatment failures
  Voclosporin · Sep 9, 2025 · ClinicalTrials.gov

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