Actively Recruiting
Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Led by Centre hospitalier de l'Université de Montréal (CHUM) · Updated on 2025-04-11
35
Participants Needed
3
Research Sites
222 weeks
Total Duration
On this page
Sponsors
C
Centre hospitalier de l'Université de Montréal (CHUM)
Lead Sponsor
M
McGill University
Collaborating Sponsor
AI-Summary
What this Trial Is About
The goal of this pilot study is to assess the feasibility of a larger study on the efficacy of mycophenolate mofetil in people diagnosed with systemic sclerosis with mild lung involvement. Participants will be recruited over 12 months at 3 academic centers and assigned randomly to receive either mycophenolate mofetil or placebo, a look-alike substance that contains no active drug, for 96 weeks.
CONDITIONS
Official Title
Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Able and willing to provide informed consent and follow the study protocol
- Adults aged 18 years and older, any gender or ethnicity
- Diagnosed with systemic sclerosis based on 2013 ACR-EULAR criteria
- Evidence of interstitial lung disease affecting less than 20% of lungs on HRCT scan within 12 months
- ILD diagnosis made within 7 years before screening
- Forced vital capacity of 80% predicted or higher on pulmonary tests within 6 months
- Able to communicate in French or English
You will not qualify if you...
- Progressive pulmonary fibrosis with worsening symptoms, radiological or physiological progression in past year without other explanation
- Current use of MMF, mycophenolic acid, azathioprine, calcineurin inhibitors, tocilizumab, nintedanib, pirfenidone, or corticosteroids over prednisone 10 mg/day
- Cyclophosphamide use within 1 year before screening
- Rituximab use within 6 months before screening
- Cell therapies including stem cell transplant within 1 year before screening
- Use of other biological, targeted synthetic, or investigational immunosuppressive drugs at screening
- Contraindications to MMF including pregnancy or breastfeeding
- Female of childbearing potential not using reliable contraception
- Persistent low white blood cell count (<3.0 x10^3/µL), low platelets (<100 x10^3/µL), or anemia (hemoglobin <100 g/L)
- Elevated liver enzymes or bilirubin >1.5 times normal except Gilbert's disease
- Uncontrolled congestive heart failure
- Active infection
- Active cancer except certain skin or cervical cancers fully removed
- Active peptic ulcer disease
- Serious other medical illnesses or drug abuse affecting safety
- Use of drugs with major interactions with MMF
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 3 locations
1
Centre hospitalier de l'Université de Montréal (CHUM)
Montreal, Quebec, Canada, H2X 3E4
Actively Recruiting
2
Jewish General Hospital - CIUSSS-COMTL
Montreal, Quebec, Canada, H3T 1E2
Not Yet Recruiting
3
Institut Universitaire de Cardiologie et Pneumologie de Québec
Québec, Quebec, Canada
Not Yet Recruiting
Research Team
S
Sabrina Hoa, MD MSc
CONTACT
U
Unité d'innovation thérapeutique, CHUM
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
OTHER
Number of Arms
2
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