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Immunosuppressant

Voclosporin + Mycophenolate Mofetil for Lupus (DIVERT Trial)

Phase 2

Waitlist Available

Research Sponsored by National Institute of Allergy and Infectious Diseases (NIAID)

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Moderately severe, active, but non-organ threatening disease. Specifically, signs or symptoms meeting criteria for a minimum of 2 British Isles Lupus Assessment Group B (BILAG B moderate) activity scores in any organ systems or 1 BILAG A (severe) score in the constitutional, musculoskeletal or mucocutaneous system at the time of screening

Convincing diagnosis of SLE

Must not have

Human immunodeficiency virus (HIV) infection

Any participant with plans for major surgery during the time of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from the day of stage 3 randomization until the date of stage 3 clinical response, assessed up to the week 24 visit

Summary

This trial is testing if a 24 week course of MMF could help improve symptoms for certain subsets of SLE patients that have been identified through immunological testing.

Who is the study for?

This trial is for adults with Systemic Lupus Erythematosus (SLE) who meet specific criteria, including moderately severe disease without organ-threatening complications. Participants must have completed their COVID-19 vaccinations, agree to use contraception if applicable, and cannot be pregnant or breastfeeding. They should not have severe kidney issues or other conditions that would make the study risky.

What is being tested?

The trial is testing the effectiveness of Mycophenolate Mofetil (MMF), alone or combined with Voclosporin, over a period of 24 weeks in patients with SLE. It aims to see how these treatments affect different immune system profiles in lupus patients and whether gene expression patterns can predict treatment response.

What are the potential side effects?

Possible side effects include increased risk of infection due to immune system suppression, gastrointestinal problems like stomach pain or diarrhea, potential liver issues indicated by blood tests changes, and possible negative reactions at injection sites.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My lupus is active but not life-threatening, affecting at least two parts of my body moderately or one part severely.

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I have been diagnosed with systemic lupus erythematosus (SLE).

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I completed my initial COVID-19 vaccination series over 14 days ago.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am HIV positive.

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I plan to undergo major surgery during the trial period.

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My blood pressure is not higher than 150/100, even with up to 3 medications.

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I had severe kidney inflammation over 2 years ago without any documented treatment.

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I haven't been hospitalized or needed IV antibiotics for infections in the last month.

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I cannot reduce my steroid use to 10 mg/day or less by the study start date.

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I have not taken more than 40 mg/day of prednisone in the last 4 weeks or more than 20 mg/day at screening.

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I haven't taken any experimental drugs recently, except for COVID-19 treatments or vaccines.

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I do not have severe or unstable kidney inflammation.

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My kidney function is reduced, with an eGFR below 45.

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I have a history of liver disease not caused by lupus, except for fatty liver.

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I have had severe kidney inflammation in the past 2 years.

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I have not had a moderate infection in the last 2 weeks.

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I have not received any live vaccines in the last 8 weeks.

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I have severe lupus affecting my heart, lungs, brain, stomach, eyes, kidneys, or blood.

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I have been on a stable dose of hydroxychloroquine, chloroquine, or quinacrine for at least 2 months.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from the day of stage 3 randomization until the date of stage 3 clinical response, assessed up to the week 24 visit

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from the day of stage 3 randomization until the date of stage 3 clinical response, assessed up to the week 24 visit

This trial's timeline: 3 weeks for screening, Varies for treatment, and from the day of stage 3 randomization until the date of stage 3 clinical response, assessed up to the week 24 visit for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

The cumulative incidence of participants who experience a Stage 2 treatment failure

Secondary study objectives

Clinical response in Stage 2 defined by the BILAG-based Combined Lupus Assessment (BICLA) at Stage 2 Week 24

Clinical response in Stage 3

The cumulative incidence of participants who experience a Stage 3 treatment failure

+10 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478

23%

Blood/Bone marrow

11%

Cardiovascular

Pulmonary

Gastrointestinal

Hepatic

Graft versus host disease with infection and organ failure

Dermatology/Skin

respiratory failure

Hemorrhage

subdural hematoma

thrombosis

Renal/Genitourinary

Metabolic/Laboratory

100%

80%

60%

40%

20%

Study treatment Arm

Arm II (TBI, Transplant, GVHD Prophylaxis)

Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

4Treatment groups

Experimental Treatment

Placebo Group

Group I: MMF+ VoclosporinExperimental Treatment2 Interventions

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 80 mg methylprednisolone acetate 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

Group II: MMF+ Placebo for VoclosporinExperimental Treatment2 Interventions

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 80 mg methylprednisolone acetate 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

Group III: MMFExperimental Treatment1 Intervention

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

Group IV: Placebo for MMFPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Mycophenolate Mofetil

1997

Completed Phase 4

~2380

Voclosporin

2022

Completed Phase 3

~1000