Using Mycophenolate Mofetil for Systemic Sclerosis with Mild Lung Issues

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This pilot study aims to evaluate the feasibility of a larger clinical trial assessing the effectiveness of mycophenolate mofetil (MMF) in patients with systemic sclerosis who have mild interstitial lung disease. Participants will be randomly assigned to receive either MMF or a placebo for a duration of 96 weeks. The study will take place over 12 months across three academic centers, focusing on recruitment rates and preliminary efficacy outcomes. The goal is to gather data that could support a future phase III trial.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Able and willing to provide informed consent and adhere to study protocol;
2. Women and men of all race/ethnicity, aged 18 years and older;
3. SSc based on 2013 ACR-EULAR classification criteria;
4. Presence of interstitial lung disease on HRCT scan, obtained within 12 months before screening, that shows fibrosis affecting less than 20% of the lungs, as confirmed by an expert radiologist;
5. Diagnosis of ILD within 7 years before screening;
6. Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening;
7. Able to communicate in French or English;

Exclusion Criteria:

1. Progressive pulmonary fibrosis, defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation, as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline;
2. Use of medications with putative lung disease-modifying properties:

   1. Current use of MMF, mycophenolic acid, azathioprine, calcineurin inhibitors (e.g. tacrolimus, cyclosporin A), tocilizumab, nintedanib, pirfenidone or corticosteroids (Prednisone equivalent dose \>10 mg/day) at time of screening
   2. Cyclophosphamide within one year prior to screening
   3. Rituximab within 6 months prior to screening
   4. Cell therapies (including stem cell transplantation) within one year prior to screening
3. Current use of other biological, targeted synthetic or investigational products with immunosuppressive effects (e.g. TNF inhibitors, abatacept, tofacitinib) at time of screening
4. Any contraindication to MMF, including:

   1. Pregnancy and/or breastfeeding
   2. Female of childbearing potential not using reliable method of contraception
   3. Persistent leucopenia (white blood cell count \<3.0 x103/μL)
   4. Persistent thrombocytopenia (platelet count \<100 x103/μL)
   5. Persistent anemia (hemoglobin \<100 g/L)
   6. Baseline liver enzymes (alanine transaminase (ALT) or aspartate transaminase (AST)) or bilirubin \>1.5 times the upper limit of normal, other than due to Gilbert's disease
   7. Uncontrolled congestive heart failure
   8. Active infection (lung or elsewhere)
   9. Active solid or hematological malignancy (other than basal cell cancer of the skin or cervical carcinoma in situ removed entirely by biopsy)
   10. Active peptic ulcer disease
   11. Other serious concomitant medical illness, unreliability or drug abuse that might compromise the patient's ability to safely take MMF
   12. Use of drugs or products with significant interactions with MMF

Where it's running

• Centre hospitalier de l'Université de Montréal (CHUM)
  Montreal, Quebec, Canada Recruiting
• Jewish General Hospital - CIUSSS-COMTL
  Montreal, Quebec, Canada Not yet recruiting
• Institut Universitaire de Cardiologie et Pneumologie de Québec
  Québec, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Sabrina Hoa, MD — Centre hospitalier de l'Université de Montréal (CHUM)
• Study coordinator: Sabrina Hoa, MD MSc
• Email: sabrina.anh-tu.hoa.med@ssss.gouv.qc.ca
• Phone: 514-890-8000

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Nintedanib plus tocilizumab for systemic sclerosis with interstitial lung disease

  This trial will test whether combining nintedanib and tocilizumab helps adults with systemic sclerosis and interstitial lung disease do better than standard treatments over 56 weeks.

  Recruiting Phase 3 National Institute of Geriatrics, Rheumatology and Rehabilitation, Poland · Warsaw, Masovian Voivodeship · NCT06297096

• Registry of patients with connective tissue diseases and lung issues

  This study is collecting health information from patients with connective tissue diseases to see how often they develop lung problems and to understand their treatment over time.

  Recruiting Medical University Innsbruck · Innsbruck · NCT04095351

• High-dose immunoablative therapy with stem cell transplantation for systemic sclerosis

  This study is testing a high-dose treatment followed by stem cell transplantation to see if it can help people with systemic sclerosis feel better and stay healthier.

  Recruiting at 3 sites Phase 2 University of Pittsburgh · Pittsburgh, Pennsylvania and 2 other locations · NCT03630211

• Telitacicept for primary Sjögren’s with interstitial lung disease

  This study tests whether Telitacicept helps people with primary Sjögren’s syndrome and interstitial lung disease compared with standard immunosuppressants.

  Recruiting Peking University People's Hospital · Beijing · NCT07843381

• Inhaled mosliciguat for pulmonary hypertension in interstitial lung disease (PH-ILD) patients

  This study tests inhaled mosliciguat versus placebo in people with PH-ILD to see if it helps with their condition.

  Recruiting at 3 sites Phase 3 Pulmovant, Inc. · Kissimmee, Florida and 2 other locations · NCT07816185

• Treprostinil Palmitil Inhalation Powder for Progressive Pulmonary Fibrosis

  A 52-week study will test whether once-daily Treprostinil Palmitil Inhalation Powder helps lung function in adults with progressive pulmonary fibrosis compared to placebo.

  Recruiting Phase 3 Insmed Incorporated · DuBois, Pennsylvania · NCT07805785

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.