Mycophenolate Mofetil in Systemic Sclerosis With Subclinical Interstitial Lung Disease

Sponsor
Centre hospitalier de l'Université de Montréal (CHUM)
Study ID
NCT05785065
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Mycophenolate Mofetil — DRUG
    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
  • Placebo — OTHER
    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

Study Details

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.

Key Dates

First listed
Mar 27, 2023
Start date
Aug 29, 2024
Status verified
Apr 2025
Primary completion
Dec 31, 2026
Completion
Dec 31, 2028

Study Design

Enrollment
35 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER

Arms

  • Experimental: Mycophenolate mofetil
    2 to 4 capsules of mycophenolate mofetil twice daily.
  • Placebo Comparator: Placebo
    2 to 4 capsules of placebo twice daily.

Primary Outcome Measure

Total number of potentially eligible patients identified per site [ Time Frame: Over one year ]

Central Contacts

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