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Immunosuppressant

Mycophenolate Mofetil for Systemic Sclerosis with Interstitial Lung Disease (SSc-mILD Trial)

Phase 2
Waitlist Available
Led By Sabrina Hoa, MD
Research Sponsored by Centre hospitalier de l'Université de Montréal (CHUM)
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Forced vital capacity of 80% predicted and above, on pulmonary function tests obtained within 6 months before screening
SSc based on 2013 ACR-EULAR classification criteria
Must not have
Any contraindication to MMF, including pregnancy and/or breastfeeding, female of childbearing potential not using reliable method of contraception, persistent leucopenia, persistent thrombocytopenia, persistent anemia, baseline liver enzymes or bilirubin >1.5 times the upper limit of normal, uncontrolled congestive heart failure, active infection, active solid or hematological malignancy, active peptic ulcer disease, other serious concomitant medical illness, unreliability or drug abuse that might compromise the patient's ability to safely take MMF, use of drugs or products with significant interactions with MMF
Progressive pulmonary fibrosis, defined as at least two of three criteria (worsening symptoms, radiological progression, and physiological progression) occurring within the past year with no alternative explanation, as defined by the 2022 ATS/ERS/JRS/ALAT Clinical Practice Guideline
Timeline
Screening 3 weeks
Treatment Varies
Follow Up at 96 weeks

Summary

This trial will study the effects of a drug on people with mild lung involvement from systemic sclerosis. Participants will get either drug or placebo over 96 weeks at 3 centers.

Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Mycophenolate Mofetil may cause side effects like stomach problems, blood cell count changes leading to increased infection risk or anemia, liver enzyme increases indicating potential liver damage, and possible interactions with other drugs.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
Select...
My lung function test shows I breathe well, meeting the required standard.
Select...
I have been diagnosed with systemic sclerosis according to the 2013 criteria.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
Select...
I do not have any health conditions or situations that would make it unsafe for me to take MMF.
Select...
My lung scarring has worsened in the last year without other causes.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~at 96 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and at 96 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Secondary study objectives
Frequency of treatment-related adverse events
Other study objectives
Change from baseline in 36-items short form survey (SF-36) at 48 weeks
Change from baseline in 36-items short form survey (SF-36) at 96 weeks
Change from baseline in 6-minute walk oxygen desaturation at 96 weeks
+27 more

Side effects data

From 2014 Phase 3 trial • 87 Patients • NCT00075478
23%
Blood/Bone marrow
11%
Cardiovascular
9%
Pulmonary
7%
Gastrointestinal
7%
Hepatic
5%
Graft versus host disease with infection and organ failure
2%
Dermatology/Skin
2%
respiratory failure
2%
Hemorrhage
2%
subdural hematoma
2%
thrombosis
2%
Renal/Genitourinary
2%
Metabolic/Laboratory
100%
80%
60%
40%
20%
0%
Study treatment Arm
Arm II (TBI, Transplant, GVHD Prophylaxis)
Arm I (Chemotherapy, TBI, Transplant, GVHD Prophylaxis)

Trial Design

2Treatment groups
Experimental Treatment
Placebo Group
Group I: Mycophenolate mofetilExperimental Treatment1 Intervention
2 to 4 capsules of mycophenolate mofetil twice daily.
Group II: PlaceboPlacebo Group1 Intervention
2 to 4 capsules of placebo twice daily.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Mycophenolate Mofetil
1997
Completed Phase 4
~2380

Find a Location

Who is running the clinical trial?

St. Joseph's Healthcare HamiltonOTHER
200 Previous Clinical Trials
26,774 Total Patients Enrolled
Centre hospitalier de l'Université de Montréal (CHUM)Lead Sponsor
377 Previous Clinical Trials
131,345 Total Patients Enrolled
McGill UniversityOTHER
408 Previous Clinical Trials
1,018,373 Total Patients Enrolled

Media Library

Mycophenolate Mofetil (Immunosuppressant) Clinical Trial Eligibility Overview. Trial Name: NCT05785065 — Phase 2
Systemic Sclerosis Research Study Groups: Placebo, Mycophenolate mofetil
Systemic Sclerosis Clinical Trial 2023: Mycophenolate Mofetil Highlights & Side Effects. Trial Name: NCT05785065 — Phase 2
Mycophenolate Mofetil (Immunosuppressant) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05785065 — Phase 2
~0 spots leftby Dec 2024
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