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New treatment option for Systemic Sclerosis With Lung Involvement
Official title Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease
ClinicalTrials.gov ID: NCT05785065
What this study is testing
What is Mycophenolate Mofetil?
Mycophenolate Mofetil is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for systemic sclerosis with lung involvement.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Time commitment: about 96 weeks
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Able and willing to provide informed consent and adhere to study protocol;
- Women and men of all race/ethnicity, aged 18 years and older;
- SSc based on 2013 ACR-EULAR classification criteria;
- Presence of interstitial lung disease on HRCT scan, obtained within 12 months before screening, that shows fibrosis affecting less than 20% of the...
- Diagnosis of ILD within 7 years before screening;
You likely can't join if
- Progressive pulmonary fibrosis, defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological...
- Use of medications with putative lung disease-modifying properties:
- Current use of MMF, mycophenolic acid, azathioprine, calcineurin inhibitors (e.g. tacrolimus, cyclosporin A), tocilizumab, nintedanib, pirfenidone or...
- Cyclophosphamide within one year prior to screening
- Rituximab within 6 months prior to screening
- Cell therapies (including stem cell transplantation) within one year prior to screening
See the full eligibility criteria
- Able and willing to provide informed consent and adhere to study protocol;
- Women and men of all race/ethnicity, aged 18 years and older;
- SSc based on 2013 ACR-EULAR classification criteria;
- 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;
- Diagnosis of ILD within 7 years before screening;
- Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening;
- Able to communicate in French or English;
- 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...
- Use of medications with putative lung disease-modifying properties:
- 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...
- Cyclophosphamide within one year prior to screening
- Rituximab within 6 months prior to screening
- Cell therapies (including stem cell transplantation) within one year prior to screening
- Current use of other biological, targeted synthetic or investigational products with immunosuppressive effects (e.g. TNF inhibitors, abatacept, tofacitinib) at time of screening
- Any contraindication to MMF, including:
- Pregnancy and/or breastfeeding
- Female of childbearing potential not using reliable method of contraception
- Persistent leucopenia (white blood cell count \<3.0 x103/μL)
- Persistent thrombocytopenia (platelet count \<100 x103/μL)
- Persistent anemia (hemoglobin \<100 g/L)
- 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
- Uncontrolled congestive heart failure
- Active infection (lung or elsewhere)
- Active solid or hematological malignancy (other than basal cell cancer of the skin or cervical carcinoma in situ removed entirely by biopsy)
- Active peptic ulcer disease
- Other serious concomitant medical illness, unreliability or drug abuse that might compromise the patient's ability to safely take MMF
- Use of drugs or products with significant interactions with MMF
The study team makes the final eligibility decision.
Where it's taking place
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The study runs about 96 weeks per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Montreal, Quebec, Canada; Québec, Quebec, Canada. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.