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NCT03221257 · ClinicalTrials.gov registry record · Phase 2

Scleroderma Lung Study III - Combining Pirfenidone With Mycophenolate

A Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic, sponsored by Michael Roth.

Completed
Registry status
Phase 2
Development phase
51
Enrollment target
16
Study locations

NCT03221257 is a Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic that has completed, run by Michael Roth. The registered enrollment target is 51 participants, below the 565-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (91% lower). The trial reports 16 study locations across 15 states.

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The verdict

NCT03221257, a Phase 2 study of Interstitial Lung Disease and Scleroderma, Systemic, has completed, sponsored by Michael Roth.

COMPLETED
Registry status
Phase 2
Development phase
51 participants
Enrollment target
16
Study locations

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).

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

FieldValue
Enrollment Target 51 participants
Start Date 2017-11-28
Est. Completion 2022-06-13
Phase Phase 2

Sponsor

Michael Roth

2 total trials

What the Registry Record Tells You About NCT03221257

The ClinicalTrials.gov registry entry for NCT03221257 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 51 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 565-participant average among 36 other Interstitial Lung Disease trials with a reported enrollment target (91% lower). The listed sponsor is Michael Roth, which has 2 total studies on file at ClinicalTrials.gov.

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.

NCT03221257 reports 16 study locations spanning 15 distinct geographic areas - top geographies include Massachusetts, California, Colorado.

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.

What interventions are being tested in trial NCT03221257?

The interventions under investigation include: Mycophenolate Mofetil (MMF) (DRUG), Pirfenidone (PFD) (DRUG), Placebo (Plac) (DRUG).

Who is sponsoring clinical trial NCT03221257?

This trial is sponsored by Michael Roth, which has 2 total clinical trials registered on ClinicalTrials.gov.

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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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

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