Mycophenolate Mofetil for Systemic Sclerosis with Interstitial Lung Disease

(SSc-mILD Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Overseen by Sabrina Hoa, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

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

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

Sabrina Hoa, MD

Principal Investigator

Centre hospitalier de l'Université de Montréal (CHUM)

Eligibility Criteria

This trial is for adults over 18 with systemic sclerosis and mild lung involvement, diagnosed within the last 7 years. Participants must have a stable lung function and be able to consent and follow the study plan. They can't join if they've had worsening lung fibrosis in the past year, are on certain other medications, pregnant or not using contraception, have blood disorders or liver issues, heart failure, active infections or cancer.

Inclusion Criteria

My lung function test shows I breathe well, meeting the required standard.

I have been diagnosed with systemic sclerosis according to the 2013 criteria.

My lung scan shows less than 20% fibrosis, confirmed by a specialist.

Exclusion Criteria

I do not have any health conditions or situations that would make it unsafe for me to take MMF.

I am taking medication that could affect my lung condition.

My lung scarring has worsened in the last year without other causes.

Treatment Details

Interventions

• Mycophenolate Mofetil (Immunosuppressant)
• Placebo (Other)

Trial Overview The study tests Mycophenolate Mofetil (MMF) against a placebo in people with systemic sclerosis who also have subclinical interstitial lung disease. It's designed to see if it's feasible to do a larger study on MMF's effectiveness for these patients over a period of 96 weeks.

Participant Groups

Group I: Mycophenolate mofetil Experimental Treatment 1 Intervention

2 to 4 capsules of mycophenolate mofetil twice daily.

Group II: Placebo Placebo Group 1 Intervention

2 to 4 capsules of placebo twice daily.

Mycophenolate Mofetil is already approved in Canada, Japan for the following indications:

Approved in Canada as Cellcept for:

• Prevention of acute organ rejection in kidney, liver, and heart transplant patients
• Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis

Approved in Japan as Cellcept for:

• Prevention of acute organ rejection in kidney, liver, and heart transplant patients
• Treatment of autoimmune diseases such as lupus nephritis and rheumatoid arthritis

Who Is Running the Clinical Trial?

Centre hospitalier de l'Université de Montréal (CHUM)

Lead Sponsor

Trials

389

Recruited

143,000+

Dr. Réjean Lapointe

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Medical Officer since 2023

MD from Université de Montréal

Dr. Fabrice Brunet

Centre hospitalier de l'Université de Montréal (CHUM)

Chief Executive Officer since 2015

MD from Université de Montréal

St. Joseph's Healthcare Hamilton

Collaborator

Trials

203

Recruited

26,900+

Dr. Michael Heenan

St. Joseph's Healthcare Hamilton

Chief Executive Officer since 2023

PhD in Business Administration Health Policy Management, MBA in Health Services Management, and Bachelor of Arts from McMaster University

Dr. Sarah Jarmain

St. Joseph's Healthcare Hamilton

Chief Medical Officer

MD

McGill University

Collaborator

Trials

421

Recruited

1,017,000+

Philippe Drouet

McGill University

Chief Executive Officer since 2021

Master of Science and Bachelor in Chemical Engineering from McGill University

Marianne Mancini

McGill University

Chief Medical Officer

BS in Nutritional Sciences from McGill University

University of Calgary

Collaborator

Trials

827

Recruited

902,000+

Dr. Shweta Patel

University of Calgary

Chief Medical Officer since 2020

MD from the University of Baroda Medical College, India

Dr. Edward McCauley

University of Calgary

President and Vice-Chancellor since 2018

PhD in Ecology and Evolutionary Biology from the University of California, Santa Barbara

Canadian Institutes of Health Research (CIHR)

Collaborator

Trials

1,417

Recruited

26,550,000+

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Executive Officer

MD, University of Ottawa

Dr. Paul C. Hébert

Canadian Institutes of Health Research (CIHR)

Chief Medical Officer

MD, University of Ottawa

Sclérodermie Québec

Collaborator

Trials

1

Recruited

40+

Jewish General Hospital

Collaborator

Trials

144

Recruited

283,000+

Dr. Justin Cross

Jewish General Hospital

Chief Medical Officer since 2023

MD

Dr. Lawrence Rosenberg

Jewish General Hospital

Chief Executive Officer since 2015

MSc and PhD in Experimental Surgery from McGill University, Master of Engineering from the University of Waterloo