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Immunosuppressant
Voclosporin + Mycophenolate Mofetil for Lupus (DIVERT Trial)
Phase 2
Recruiting
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
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
Awards & highlights
DIVERT Trial 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.Check my eligibility
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.See study design
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.
DIVERT Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My lupus is active but not life-threatening, affecting at least two parts of my body moderately or one part severely.
Select...
I have been diagnosed with systemic lupus erythematosus (SLE).
Select...
I completed my initial COVID-19 vaccination series over 14 days ago.
DIVERT Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
The cumulative incidence of participants who experience a Stage 2 treatment failure
Secondary outcome measures
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
+13 moreSide effects data
From 2014 Phase 3 trial • 87 Patients • NCT0007547823%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)
DIVERT 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
Voclosporin
2022
Completed Phase 3
~980
Mycophenolate Mofetil
1997
Completed Phase 4
~2380
Find a Location
Who is running the clinical trial?
National Institute of Allergy and Infectious Diseases (NIAID)Lead Sponsor
3,269 Previous Clinical Trials
5,481,349 Total Patients Enrolled
2 Trials studying Lupus
166 Patients Enrolled for Lupus
Joan Merrill, M.D.Study ChairOklahoma Medical Research Foundation: Arthritis and Clinical Immunology Research Program
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I am HIV positive.I plan to undergo major surgery during the trial period.My blood pressure is not higher than 150/100, even with up to 3 medications.I had severe kidney inflammation over 2 years ago without any documented treatment.I have had shingles within the last 4 months.I am willing to use birth control as described in the Mycophenolate REMS brochure.I haven't been hospitalized or needed IV antibiotics for infections in the last month.My doctor thinks my condition has improved significantly.My condition improved after steroid shots, and my doctor agrees I can join Stage 2 of the trial.I am eligible for the next stage of the trial based on my recent visit.I cannot reduce my steroid use to 10 mg/day or less by the study start date.I have not taken more than 40 mg/day of prednisone in the last 4 weeks or more than 20 mg/day at screening.I haven't used specific immune-targeting drugs in the past year.My lupus is active and may need strong immune treatments.I agree that my symptoms have improved.I have hepatitis B but may still qualify if certain tests are negative.I have Hepatitis C but no current viral load.I haven't taken any experimental drugs recently, except for COVID-19 treatments or vaccines.My lupus is active but not life-threatening, affecting at least two parts of my body moderately or one part severely.In the past year, I've had severe lupus symptoms not related to skin, general health, or joints.I do not have severe or unstable kidney inflammation.My kidney function is reduced, with an eGFR below 45.I have a history of liver disease not caused by lupus, except for fatty liver.I have had severe kidney inflammation in the past 2 years.I have not had a moderate infection in the last 2 weeks.I haven't used calcineurin inhibitors in the last year.I have not received any live vaccines in the last 8 weeks.I have used Mycophenolate Mofetil within the last year.I used MMF for lupus, but it didn't control my symptoms.I have been diagnosed with systemic lupus erythematosus (SLE).I have severe lupus affecting my heart, lungs, brain, stomach, eyes, kidneys, or blood.I have no health issues preventing me from joining a study with a placebo.I completed my initial COVID-19 vaccination series over 14 days ago.I have been on a stable dose of hydroxychloroquine, chloroquine, or quinacrine for at least 2 months.
Research Study Groups:
This trial has the following groups:- Group 1: MMF
- Group 2: Placebo for MMF
- Group 3: MMF+ Voclosporin
- Group 4: MMF+ Placebo for Voclosporin
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
How many different hospitals are participating in this research project?
"There are 12 medical centres conducting this study, such as Piedmont Healthcare: Rheumatology Atlanta in Atlanta, Columbia University Medical Center: Department of Medicine, Division of Rheumatology in New york, and Yale University School of Medicine: Rheumatology, Allergy & Immunology in New Haven."
Answered by AI
Are there any current vacancies in this trial for participants?
"Presently, this clinical trial is in the process of recruiting patients. The original posting was on October 28th, 2020 and the most recent update was on November 14th, 2020."
Answered by AI
Could I possibly qualify to participate in this research?
"Eligible patients for this study are those that have libman-sacks disease and fall between the ages of 18 to 60. There is a goal to recruit 120 individuals in total."
Answered by AI
Will this research be testing any treatments on octogenarians?
"This trial is specifically for patients aged 18 to 60. However, there are 17 other clinical studies currently underway for minors and 111 research trials focused on elderly patients."
Answered by AI
What are the most common side effects of Mycophenolate Mofetil?
"There is early data supporting the safety of Mycophenolate Mofetil, but nothing yet to suggest that it effective. For this reason, it received a score of 2."
Answered by AI
How many people are being enrolled in this clinical trial?
"Yes, the trial is recruiting patients as of the most recent update on clinicaltrials.gov from November 14th, 2020. This study was first posted on October 8th, 2020 and is looking for 120 participants across 12 sites."
Answered by AI
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