A Trial to Compare Nintedanib With Placebo for Patients With Scleroderma Related Lung Fibrosis
Public ClinicalTrials.gov record NCT02597933. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Double Blind, Randomised, Placebo-controlled Trial Evaluating Efficacy and Safety of Oral Nintedanib Treatment for at Least 52 Weeks in Patients With Systemic Sclerosis Associated Interstitial Lung Disease (SSc-ILD)
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
Systemic Sclerosis (SSc) is a devastating disease of unknown etiology. Patients suffer from multiple organ fibrosis whereas lung fibrosis (interstitial lung disease, ILD) is one of the main driver for mortality. There is preclinical evidence for efficacy of nintedanib in SSc and associated ILD (SSc-ILD) and the anti-fibrotic efficacy of nintedanib was proven in idiopathic pulmonary fibrosis patients, who are presenting a similar pattern regarding lung fibrosis. Hence it is the purpose of the trial to confirm the efficacy and safety of nintedanib 150 mg bid in treating patients with SSc-ILD, compared with placebo. The trial will be conducted as a double blind, randomised, placebo-controlled trial with primary efficacy evaluation at week 52 and placebo-controlled treatment until last patient out (up to a maximum of 100 weeks). Respiratory function is globally accepted for assessment of treatment effects in patients with lung fibrosis. The chosen endpoint (Forced Vital Capacity (FVC) decline) is easy to obtain and is part of the usual examinations done in patients with SSc-ILD.
Study identification
- NCT ID
- NCT02597933
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 3
- Enrollment
- 580 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Nov 12, 2015 (Actual)
- Primary completion
- Oct 31, 2018 (Actual)
- Completion
- Nov 28, 2018 (Actual)
- Last update posted
- Dec 13, 2019
2015 – 2018
United States locations
- U.S. sites
- 44
- U.S. states
- 28
- U.S. cities
- 39
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35294 | — |
| University of California Los Angeles | Los Angeles | California | 90095 | — |
| University of California Davis | Sacramento | California | 95817 | — |
| University of California San Francisco | San Francisco | California | 94143 | — |
| Stanford University Medical Center | Stanford | California | 94305-5236 | — |
| University of Colorado Denver | Aurora | Colorado | 80045 | — |
| Yale University School of Medicine | New Haven | Connecticut | 06510 | — |
| Georgetown University | Washington D.C. | District of Columbia | 20007 | — |
| University of Florida College of Medicine | Jacksonville | Florida | 32209 | — |
| University of Miami | Miami | Florida | 33125 | — |
| The Emory Clinic | Atlanta | Georgia | 30322 | — |
| Northwestern University | Chicago | Illinois | 60611 | — |
| University of Iowa | Iowa City | Iowa | 52242 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| University of Louisville | Louisville | Kentucky | 40202 | — |
| Tulane University Hospital and Clinic | New Orleans | Louisiana | 70112 | — |
| Johns Hopkins Hospital | Baltimore | Maryland | 21224 | — |
| Boston Medical Center | Boston | Massachusetts | 02118 | — |
| University of Michigan Health System | Ann Arbor | Michigan | 48109 | — |
| University of Minnesota Masonic Cancer Center | Minneapolis | Minnesota | 55455 | — |
| Mayo Clinic-Rochester | Rochester | Minnesota | 55905 | — |
| The Lung Research Center, LLC | Chesterfield | Missouri | 63017 | — |
| Washington University School of Medicine | St Louis | Missouri | 63110 | — |
| Hospital for Special Surgery | New York | New York | 10021 | — |
| Icahn School of Medicine at Mount Sinai | New York | New York | 10029 | — |
| Columbia University Medical Center-New York Presbyterian Hospital | New York | New York | 10032 | — |
| Duke University Medical Center | Durham | North Carolina | 27710 | — |
| University of Cincinnati Health | Cincinnati | Ohio | 45219 | — |
| Cleveland Clinic | Cleveland | Ohio | 44195 | — |
| University of Toledo | Toledo | Ohio | 43614 | — |
| Penn State Milton S. Hershey Medical Center | Hershey | Pennsylvania | 17033 | — |
| University of Pennsylvania | Philadelphia | Pennsylvania | 19104 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140 | — |
| Medical University of South Carolina | Charleston | South Carolina | 29425 | — |
| University of South Carolina | Columbia | South Carolina | 29203 | — |
| Vanderbilt Pulmonary Clinic | Nashville | Tennessee | 37232-5735 | — |
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | — |
| The University Of Texas at Houston | Houston | Texas | 77030 | — |
| University of Utah Health Sciences Center | Salt Lake City | Utah | 84108 | — |
| Inova Fairfax Medical Campus | Falls Church | Virginia | 22042 | — |
| Virginia Mason Medical Center | Seattle | Washington | 98101 | — |
| University of Washington | Seattle | Washington | 98195 | — |
| Froedtert and The Medical College of Wisconsin | Milwaukee | Wisconsin | 53226 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 151 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT02597933, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 13, 2019 · Synced Oct 30, 2026
Related: full search, browse by condition, browse by drug or therapy, browse by sponsor, browse by U.S. city.
Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT02597933 live on ClinicalTrials.gov.