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Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate
NCT03221257 · View on ClinicalTrials.gov ↗
Study Summary
A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).
Conditions Studied
Interventions
- DRUG Mycophenolate Mofetil (MMF)
- DRUG Pirfenidone (PFD)
- DRUG Placebo (Plac)
Study Locations (16)
Massachusetts
- Harvard Medical School, Brigham & Women's Hospital — Boston
- Boston University, School of Medicine — Boston
California
- University of California Los Angeles — Los Angeles
Colorado
- University of Colorado — Aurora
District of Columbia
- Georgetown University — Washington D.C.
Illinois
- Northwestern University — Chicago
Indiana
- Indiana University Health — Indianapolis
Maryland
- Johns Hopkins University — Baltimore
Michigan
- University of Michigan — Ann Arbor
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 51 participants |
| Start Date | 2017-11-28 |
| Est. Completion | 2022-06-13 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03221257
The ClinicalTrials.gov registry entry for NCT03221257 describes a study currently listed as completed. It is categorized as Phase 2, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Michael Roth, which has 1 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 2 conditions, with Interstitial Lung Disease appearing as the primary indexed condition, and to 3 interventions — of which Mycophenolate Mofetil (MMF) is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03221257 reports 16 study locations spanning 15 distinct geographic areas — top geographies include Massachusetts, California, Colorado. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT03221257 about?
NCT03221257 is a clinical study titled "Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate". A Phase II multi-center, double-blind, parallel group, randomized and placebo-controlled clinical trial addressing the treatment of patients with active and symptomatic Scleroderma-related interstitial lung disease (SSc-ILD).
What is the current status of trial NCT03221257?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 51 participants. The study started on 2017-11-28. Estimated completion is 2022-06-13.
What conditions does trial NCT03221257 study?
This clinical trial studies the following conditions: Interstitial Lung Disease, Scleroderma, Systemic. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT03221257?
The interventions under investigation include: Mycophenolate Mofetil (MMF) (DRUG), Pirfenidone (PFD) (DRUG), Placebo (Plac) (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03221257?
This trial is sponsored by Michael Roth, which has 1 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT03221257 being conducted?
This trial has 16 study locations across California, Colorado, District of Columbia, Illinois, Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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