Mycophenolate Mofetil for Systemic Sclerosis with Interstitial Lung Disease
(SSc-mILD Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial explores whether mycophenolate mofetil, an immunosuppressant medication, can aid individuals with systemic sclerosis, a condition where the immune system attacks the body, causing thick skin and organ issues, particularly affecting the lungs. Researchers aim to determine if this medication is effective, compared to a placebo, in treating mild lung involvement over 96 weeks. Individuals diagnosed with systemic sclerosis and interstitial lung disease, a lung condition with scarring, but without severe lung issues, might be suitable candidates. As a Phase 2 trial, this research focuses on assessing the treatment's effectiveness in an initial, smaller group of participants.
Will I have to stop taking my current medications?
The trial requires that you stop taking certain medications that affect lung disease, such as mycophenolate mofetil, azathioprine, and some others, before joining. If you're on any of these, you may need to stop them before participating.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Research has shown that mycophenolate mofetil is usually well-tolerated by people with systemic sclerosis and interstitial lung disease. Studies have found that it can slow the decline in lung function and may even improve quality of life. Observational data suggest that mycophenolate can help stabilize lung and skin problems in these patients. A meta-analysis, which combines data from multiple studies, supported that mycophenolate is a safe option for people with these conditions. Overall, these findings indicate that the treatment appears safe.12345
Why do researchers think this study treatment might be promising?
Unlike the standard treatments for systemic sclerosis with interstitial lung disease, which often include immunosuppressants like cyclophosphamide and azathioprine, mycophenolate mofetil stands out because it selectively targets and suppresses the proliferation of T and B lymphocytes, which are key players in the autoimmune process. This targeted action could potentially lead to fewer side effects compared to broader immunosuppressive therapies. Researchers are particularly excited about mycophenolate mofetil because it has shown promise in preserving lung function while offering a more tailored approach to managing the disease.
What evidence suggests that mycophenolate mofetil might be an effective treatment for systemic sclerosis with interstitial lung disease?
Research has shown that mycophenolate mofetil (MMF), which participants in this trial may receive, can help treat systemic sclerosis with interstitial lung disease (SSc-ILD). Studies have found that MMF can improve or maintain lung function, measured by forced vital capacity. It also slows disease progression and enhances patients' quality of life. Additionally, MMF can reduce the progression of lung disease and related health issues. Overall, MMF serves as a helpful treatment option for people with SSc-ILD.24678
Who Is on the Research Team?
Sabrina Hoa, MD
Principal Investigator
Centre hospitalier de l'Université de Montréal (CHUM)
Are You a Good Fit for This Trial?
This trial is for adults over 18 with systemic sclerosis and mild lung involvement, diagnosed within the last 7 years. Participants must have a stable lung function and be able to consent and follow the study plan. They can't join if they've had worsening lung fibrosis in the past year, are on certain other medications, pregnant or not using contraception, have blood disorders or liver issues, heart failure, active infections or cancer.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive either mycophenolate mofetil or placebo for 96 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Mycophenolate Mofetil
- Placebo
Mycophenolate Mofetil is already approved in European Union, United States, Canada, Japan for the following indications:
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prophylaxis of organ rejection in patients receiving allogeneic renal, cardiac, or hepatic transplants
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
- Prevention of acute organ rejection in kidney, liver, and heart transplant patients
- Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis
Find a Clinic Near You
Who Is Running the Clinical Trial?
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
St. Joseph's Healthcare Hamilton
Collaborator
McGill University
Collaborator
University of Calgary
Collaborator
Canadian Institutes of Health Research (CIHR)
Collaborator
Sclérodermie Québec
Collaborator
Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Collaborator
Jewish General Hospital
Collaborator