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Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease

Study acronym: SSc-mILD
StatusRecruiting
PhasePhase 2
Started2024-08-29
View on ClinicalTrials.gov ↗

Amendment history

2025-04-09
notable
Not Yet Recruiting→Recruiting Study Status, Sponsor/Collaborators, Oversight, Contacts/Locations v3
Trial statusNot Yet Recruiting→Recruiting
Primary completion date2024-12→2026-12
Completion date2026-12→2028-12
Start dateestimated 2023-12→confirmed 2024-08-29
Study sites3 entries, revised
St-Joseph'sInstitut HealthcareUniversitaire Hamiltonde Cardiologie et Pneumologie de Québec
Collaborators6 entries, revised
St.Institut Joseph'suniversitaire Healthcarede Hamiltoncardiologie et de pneumologie de Québec, University Laval
2023-10-13
minor
Study Status v2
Start date2023-09→2023-12
2023-07-06
minor
Study Status v1
Start date2023-05→2023-09
2023-03-14
minor
Original filing
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.
Trial Details
NCT Number NCT05785065
Lead Sponsor Centre hospitalier de l'Université de Montréal (CHUM)
Collaborators: McGill University, University of Calgary, Jewish General Hospital, Canadian Institutes of Health Research (CIHR), Sclérodermie Québec, Institut universitaire de cardiologie et de pneumologie de Québec, University Laval
Conditions Systemic Sclerosis With Lung Involvement, Systemic Sclerosis, Interstitial Lung Disease
Enrollment 35 participants
Start Date 2024-08-29
Primary Completion 2026-12 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-09-29