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RECRUITING
NCT05785065
PHASE2

Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease

Sponsor: Centre hospitalier de l'Université de Montréal (CHUM)

View on ClinicalTrials.gov

Summary

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.

Official title: Randomized Double-Blind Placebo-Controlled Clinical Trial to Assess the Efficacy of Mycophenolate Mofetil in Subclinical Interstitial Lung Disease Associated With Systemic Sclerosis: a Feasibility Study

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

35

Start Date

2024-08-29

Completion Date

2028-12

Last Updated

2025-04-11

Healthy Volunteers

No

Interventions

DRUG

Mycophenolate Mofetil

The participant will receive 500 mg to 1000 mg twice daily of mycophenolate mofetil administered orally for 96 weeks. The dose scheduling will be as follow: Weeks 1 and 2: 500 mg twice a day Weeks 3 and 4: 750 mg twice a day Weeks 5 to 96: 1000 mg twice a day

OTHER

Placebo

The participant will receive 500 mg to 1000 mg twice daily of placebo administered orally for 96 weeks. The dose scheduling will be as follow: Weeks 1 and 2: 500 mg twice a day Weeks 3 and 4: 750 mg twice a day Weeks 5 to 96: 1000 mg twice a day

Locations (3)

Centre hospitalier de l'Université de Montréal (CHUM)

Montreal, Quebec, Canada

Jewish General Hospital - CIUSSS-COMTL

Montreal, Quebec, Canada

Institut Universitaire de Cardiologie et Pneumologie de Québec

Québec, Quebec, Canada