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Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease

NCT05785065 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 35

Last updated 2025-04-11

No results posted yet for this study

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.

Conditions

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

Sponsors & Collaborators

  • McGill University

    collaborator OTHER

  • University of Calgary

    collaborator OTHER

  • Jewish General Hospital

    collaborator OTHER

  • Canadian Institutes of Health Research (CIHR)

    collaborator OTHER_GOV

  • Sclérodermie Québec

    collaborator UNKNOWN

  • Institut universitaire de cardiologie et de pneumologie de Québec, University Laval

    collaborator OTHER

  • Centre hospitalier de l'Université de Montréal (CHUM)

    lead OTHER

Principal Investigators

  • Sabrina Hoa, MD · Centre hospitalier de l'Université de Montréal (CHUM)

Study Design

Allocation
RANDOMIZED
Purpose
OTHER
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2024-08-29
Primary Completion
2026-12-31
Completion
2028-12-31

Countries

  • Canada

Study Locations

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Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05785065 on ClinicalTrials.gov