Note: This study is currently only recruiting patients in the hospital.

If you are interested in being notified if this study begins recruiting from the general population, please use the 'I Am Interested' button below.

Mycophenolate Mofetil alone or with Voclosporin for Systemic Lupus Erythematsus (SLE)

The main reason this research study is being done is to see if mycophenolate mofetil (MMF) by itself is helpful for treatment of Systemic Lupus Erythematosus (SLE, lupus) compared to a placebo (an inactive substance).

Massachusetts General Hospital Autoimmune Diseases
15 visits over 56 weeks
Estimated Time Commitment
Male, Female, Other, 18-60 years
May Be Eligible
Payment up to $20, Meals
May Be Offered
Survey, Blood draw, Injection or IV, Office visit, Personal health tracking, Medication
May Be Required
 
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This project is not recruiting.

Who can participate

Generally, participants are eligible for this research study if they meet all of the following eligibility criteria: 



  • Aged ≥ 18 and ≤ 60 years at the time of informed consent

  • Meets European League Against Rheumatism/American College of
    Rheumatology (EULAR/ACR) 2019 criteria for SLE

  • Have moderate to severe, active, non-organ threatening lupus 

  • No medical or other condition that would prohibit participation in a placebo-controlled, outpatient study 

  • Women of childbearing potential must have negative pregnancy test at Screening and willing to use reliable methods of contraception 

  • Complete SARS-CoV-2 primary vaccine series and up-to-date on booster doses according to CDC guidelines


About 120 participants will be in this study at about 15 study sites in the United States.


 

Who cannot participate

Generally, participants are NOT eligible for this research study if they meet any of the following exclusion criteria:



  • Unable or unwilling to provide written informed consent or comply with the study protocol

  • Evidence of chronic kidney disease 

  • History of cirrhosis or choronic liver disease unrelated to SLE other than fatty liver disease 

  • Screening laboratory values that do not fall within study eligible ranges 

  • Use of MMF within 1 year of randomization 

  • Use of calcineurin inhibitors (CNI) within 1 year of randomization 

  • Use of rituximab, obinutuzumab, ocrelizumab, or long-acting cellular deplation agents within 1 year of randomization 

  • History of intolerance or allergy to MMF, voclosporin or long-acting corticosteroid preparations 

  • Women who are pregnant, breadfeeding, or planning pregnancy from the time of consent until 6 weeks after completion of the study 

  • Plans for major surgery during the time of the trial 

  • Evidence at Screening of the following infections: 

    • HIV, Hepatitis B, Hepatitis C



  • Recipient of live attenuated vaccine(s) within 8 weeks of Screening 


Additional exclusionary criterion may deem interested participants ineligible for this research study. Full eligible will be reviewed and confirmed prior to the initiation of the official Screening in Stage 1. 

What you may be asked to do

Total maximum duration of this study is 56 weeks. 


If you choose to take part in this study, you will need to sign and date the informed consent form before we do any study procedures. This study is divided into three stages:



  • Stage 1: Screening and study treatment with one or more steroid shots to control the lupus while other lupus medications are withdraw.

  • Stage 2: Randomization to MMF or placebo (sugar pill with no active study drug).

  • Stage 3: Re-randomization to MMF and voclosporin or MMF and placebo.


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Stage 1: Screening Lupus Medicaion Withdrawl 


Once you have signed and dated the informed consent form, the screening phase of the study is started. Your study team can tell you how long this visit will take. You will be in the screening phase for up to 28 days.


In order to join this study, you must have completed a COVID-19 vaccination series with the last shot given at least 14 days prior to the screening visit. The following will happen during Stage 1:



  • Medical history and physical exam 

  • Electrocardiogram (ECG) 

  • Participant reported questionnaires 

  • Steroid injection 

  • Lupus medication withdrawl 

  • COVID-19 testing 

  • Research labs


Stage 2: Randomization to MMF or placebo 


If you qualify for Stage 2, you will be assigned randomly (like flipping a coin, 50/50 chance) to receive either MMF or placebo. Neither you nor the study doctors will know what you are taking. The first few weeks we will slowly increase the dose of MMF to avoid side effects. Once you are on full dose of MMF/placebo you will take this study drug for up to 48 weeks or as long as your lupus remains quiet. The following will happen during Stage 2: 



  • Randomization to MMF ro placebo treatment

  • Review of health and medications 

  • Brief physical exam 

  • Vital signs

  • Lupus assessment 

  • Participant reported questionnaires 

  • Clinical labs

  • Research labs 


If you are doing well on the study drug (MMF or placebo), you will stay in Stage 2 for up to 48 weeks.


If your illness begins to worsen at any time during the first 24 weeks of Stage 2, you and your study doctor will discuss moving into Stage 3. Prior to moving into Stage 3, if you and the study doctor think that another steroid shot is likely to help you, you can be given another shot. After this steroid shot you will move to Stage 3 of the study.


If your illness begins to worsen at any time during the first 24 weeks of Stage 2 and the study doctor thinks that another steroid shot would not be sufficient to help you, you will stop the study drug and new lupus medication will be provided to you outside of the study. You will continue to have study visits until week 24 or 4 weeks after the last dose of study drug, whichever is longer.


If your illness begins to worsen after week 24 of the study, you will stop the study drug and new lupus medication will be provided to you outside of the study. You will be scheduled to have one final study visit four weeks after you stopped the study drug.


Stage 3: Re-randomization to MMF and voclosporin or MMF and placebo 


If you qualify for Stage 3, you will be assigned randomly (like flipping a coin, 50/50 chance) to receive either MMF and placebo or MMF and voclosporin. Neither you nor the study doctors will know which of these you are taking. If you were taking placebo during Stage 2, we will slowly increase the dose of MMF to avoid side effects exactly like we did in Stage 2. All participants will take voclosporin 23.7mg twice a day.


If during the first two weeks of Stage 3 you and the study doctor think that another steroid shot is likely to help your symptoms, you can be given another shot.


If your illness does not get worse, you will be in Stage 3 for up to 28 weeks. The following will happen during Stage 3:



  • Re-randomization 

  • Physical exam 

  • Vital signs 

  • Lupus assessment 

  • Participant reported questionnaires 

  • Clinical labs 

  • Research labs 


During Stage 3, If your lupus worsens and requires additional medication, you will be taken off the study drug and start the new medication outside of this study. You will be scheduled to come back for a stopping study visit four weeks after stopping study drug.


Project activities may include:

  • Survey
  • Blood draw
  • Injection or IV
  • Office visit
  • Personal health tracking
  • Medication

Estimated Time Commitment

15 visits over 56 weeks

What You May Get

You will be paid up to a total of $280.00 if you complete this study. You will be paid for the visits you complete according to the following schedule:


$20.00 for Screening Week Visit.
$20.00 for Baseline Visit
$20.00 for Week 4
$20.00 for Week 8
$20.00 for Week 12
$20.00 for Week 16
$20.00 for Week 20
$20.00 for Week 24 or Stage 3-1
$20.00 for Week 28 or Stage 3-3 (Week 4)
$20.00 for Week 32 or Stage 3-4 (Week 8)
$20.00 for Week 36 or Stage 3-5 (Week 12)
$20.00 for Week 40 or Stage 3-6 (Week 16)
$20.00 for Week 44 or Stage 3-7 (Week 20)
$20.00 for Week 48 or Stage 3-8 (Week 24)


If you do not complete the study, for any reason, you will be paid for each study visit you do complete. You will be paid following each completed visit.


If you have any questions regarding your compensation for participation, please contact the study staff. 


We will reimburse you for the cost of a meal during study visits, up to $20.00 per study visit. Meal receipts must be submitted to the study staff. You will be reimbursed approximately 2 weeks after you submit your travel receipts to the study staff.

Location

Massachusetts General Hospital
55 Fruit Street, Yakwey 4B, Boston, MA 02114

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Travel

  • Accessible by public transportation
  • Parking available

Travel and Parking Details

Massachusetts General Hospital (MGH) is accesible by public transit on the MBTA, by bus or train (the Red Line).



Parking at MGH is available at a cost at multiple visitor parking garages. Parking will not be reimbursed. MGH parking available at garages around the hospital buildings, including the Fruit Street, Parkman Street and Yawkey Center parking garages. Validated patient & visitor parking rates:



  • 0-30 minutes: free

  • 30 minutes-1 hour: $10.00

  • 1-2 hours: $11.00

  • 2-4 hours: $13.00

  • 4-6 hours: $15.00

  • 6-8 hours: $18.00 

  • 8-24 hours: $20.00


Valet parking will be at a higher premium. 

Additional Information

ClinicalTrials.gov Identifier

NCT05306873


Study Phase

Phase 2: This project studies whether a medication or treatment works for people with a specific disease or condition. The drug or treatment has been studied for safety in healthy volunteers, but the project will continue to look at safety and short term side effects.


Participating Institutions


Funding Source

  • NIH or Other Federal
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