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Immunosuppressant
Pirfenidone (PFD) for Systemic Scleroderma (SLSIII Trial)
Phase 2
Waitlist Available
Led By Michael D Roth, MD
Research Sponsored by Michael Roth
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
FVC-% of ≤85% at screening
Onset of the first non-Raynaud manifestation of SSc within the prior 84 months.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 18 months
Awards & highlights
SLSIII Trial Summary
This trial is testing a new treatment for scleroderma-related interstitial lung disease (SSc-ILD).
Eligible Conditions
- Systemic Scleroderma
- Interstitial Lung Disease
SLSIII Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSLSIII Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 18 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~18 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Percent Predicted Forced Vital Capacity (FVC-%)
Other outcome measures
3.0% or Greater Improvement From Baseline in FVC-%.
Forced Vital Capacity Volume (FVC, in ml)
Greater Than 5% Improvement in FVC-%
+19 moreSide effects data
From 2022 Phase 2 trial • 51 Patients • NCT0322125781%
Nausea
44%
Diarrhea
41%
Vomiting (Emesis)
30%
Fatigue
26%
Cough
22%
Headache
19%
Dizziness
15%
COVID-19
15%
Abdominal Pain
15%
Insomnia
11%
Anxiety
11%
Pruritis (Itching)
11%
Weight Loss
11%
Bloating
7%
Shortness of Breath
7%
Photosensitivity Reaction/Erythema
7%
Yeast Infection
7%
Upper Respiratory Tract Infection (URI)
7%
Depression
7%
Rash
7%
Gastro-esophageal Reflux Disease (GERD)
7%
Heartburn
7%
Loss of Appetite
7%
Tremors
7%
Joint Pain
7%
Sinusitis
7%
Myalgia
7%
Urinary Tract Infection (UTI)
7%
Back Pain
7%
Dysphagia
7%
Constipation
7%
ALT Increased
7%
Blood in Stool
7%
Loose Stools
7%
Stomach Pain
7%
Worsening GERD
4%
Herpes Zoster Ophthalmicus
4%
Right Sided Chest Pain
4%
Extra-nodal Marginal Zone B-cell Lymphoma of the Stomach and Antrum
4%
Scleroderma Renal Crisis
4%
Basal Cell Carcinoma, Nodular
4%
Dyspnea
4%
Leukopenia
4%
Upset Stomach
4%
Cold
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo (Plac) + Mycophenolate (MMF)
Pirfenidone (PFD) + Mycophenolate (MMF)
SLSIII Trial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Pirfenidone (PFD) + Mycophenolate (MMF)Experimental Treatment2 Interventions
Participants will receive Pirfenidone (PFD) as add-on to a background therapy of Mycophenolate Mofetil (MMF).
Group II: Placebo (Plac) + Mycophenolate (MMF)Placebo Group2 Interventions
Participants will receive Placebo (Plac) as add-on to a background therapy of Mycophenolate Mofetil (MMF).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Pirfenidone (PFD)
2017
Completed Phase 2
~60
Mycophenolate Mofetil (MMF)
2000
Completed Phase 4
~690
Find a Location
Who is running the clinical trial?
University of MichiganOTHER
1,782 Previous Clinical Trials
6,364,606 Total Patients Enrolled
Genentech, Inc.Industry Sponsor
1,538 Previous Clinical Trials
567,629 Total Patients Enrolled
University of California, Los AngelesOTHER
1,521 Previous Clinical Trials
10,278,885 Total Patients Enrolled
Frequently Asked Questions
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