Phase 2 Interstitial Lung Disease Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- People who are willing and able to give informed consent and follow the study plan
- Women and men of any race or ethnicity who are 18 years of age or older
- People who have been diagnosed with systemic sclerosis (scleroderma) based on established 2013 classification criteria
- People who have scarring in their lungs (interstitial lung disease) visible on a high-resolution CT scan done within the past 12 months, where the scarring affects less than 20% of the lungs, as confirmed by an expert radiologist
- People whose lung scarring was diagnosed within the 7 years before joining the study
- People whose lungs are functioning at 80% or more of the expected level, based on breathing tests done within the past 6 months
- People who are able to communicate in French or English
Who may not be able to join:
- People whose lung scarring has been getting progressively worse over the past year, shown by at least two of the following: worsening symptoms, worsening on imaging scans, or declining lung function — with no other explanation for the decline
- People currently taking certain medications that may affect lung disease, including MMF, mycophenolic acid, azathioprine, calcineurin inhibitors (such as tacrolimus or cyclosporin A), tocilizumab, nintedanib, pirfenidone, or corticosteroids above a certain dose
- People who have taken cyclophosphamide within the past year
- People who have received rituximab within the past 6 months
- People who have undergone cell therapies, including stem cell transplantation, within the past year
- People currently taking other biological, targeted, or experimental medications that suppress the immune system (such as TNF inhibitors, abatacept, or tofacitinib)
- People who are pregnant or breastfeeding
- Women who could become pregnant and are not using a reliable form of contraception
- People with persistently low white blood cell counts, low platelet counts, or low red blood cell levels (anaemia)
- People with abnormal liver enzyme or bilirubin levels above a certain threshold (unless due to a specific harmless condition called Gilbert's disease)
- People with uncontrolled heart failure
- People with an active infection anywhere in the body, including the lungs
- People with an active cancer, except for certain completely removed skin or cervical cancers
- People with active peptic ulcer disease (stomach ulcers)
- People with other serious medical conditions, unreliability, or substance misuse that could make it unsafe to take the study medication
- People taking other drugs or products that are known to interact significantly with the study medication
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Principal Investigator: Sabrina Hoa, MD, Centre hospitalier de l'Université de Montréal (CHUM)
Phone: 514-890-8000
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
Total number of potentially eligible patients identified per site; Proportion of potentially eligible patients who provide consent per site; Proportion of consented participants who meet the eligibility criteria per site; Monthly rate of randomized participants per site; Adherence to treatment as assessed by Participant Dosing Diaries; Drug adherence rate as assessed by Pharmacy Accountability Logs; Adherence to the study protocol as assessed by the number of protocol deviations; Proportion of participants intolerant to the study drug who discontinue trial treatment; Proportion of participants...
Can't join this trial?
Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.