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Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Terminated
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Simtuzumab
Simtuzumab placebo
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic, Pulmonary, Fibrosis, IPF

Eligibility Criteria

45 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Key Inclusion Criteria:

  • Male or female subjects from 45 to 85 years of age
  • Definite IPF within 3 years prior to screening
  • Be able to walk at least 50 meters

Key Exclusion Criteria:

  • Significant diseases other than IPF
  • Obstructive lung disease
  • Aortic aneurysm greater than or equal to 3.5 cm in diameter

  • Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted.

    • N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening
    • Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located
  • Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Sites / Locations

  • University of Alabama at Birmingham
  • Arizona Pulmonary Specialists, Ltd.
  • Saint Joseph's Hospital and Medical Center
  • Arizona Pulmonary Specialists, Ltd.
  • Mayo Clinic Arizona
  • The University of Arizona
  • University of California San Diego
  • David Geffen School of Medicine at University of California, Los Angeles
  • University of California Davis Medical Center
  • University of California San Francisco
  • Sansum Clinic
  • Stanford University Medical Center
  • National Jewish Health
  • Yale University School of Medicine
  • Bay Area Chest Physicians
  • University of Florida
  • Mayo Clinic Florida
  • University of Miami
  • Sarasota Memorial Hospital
  • Tampa General Hospital
  • Cleveland Clinic Florida
  • Emory University Hospital
  • Southeastern Lung Care
  • Northwestern University
  • Rush University Medical Center
  • University of Chicago
  • Loyola University Medical Center
  • Loess Hills Clinical Research Center
  • University of Iowa Hospitals and Clinics
  • Kentuckiana Pulmonary Associates
  • University of Louisville
  • Tulane University School of Medicine
  • University of Maryland
  • Tufts University School of Medicine
  • Brigham and Women's Hospital
  • Beth Israel Deaconess Medical Center
  • Massachusetts General Hospital
  • Henry Ford Hospital
  • University of Minnesota Medical Center
  • Mayo Clinic
  • CardioPulmonary Associates
  • Saint Luke's Midwest Pulmonary Consultants
  • Washington University School of Medicine
  • Dartmouth Hitchcock Medical Center
  • Robert Wood Johnson Medical School
  • Pulmonary and Allergy Associates, PA
  • Albany Medical College
  • Jamaica Hospital Medical Center
  • North Shore University Hospital
  • Mount Sinai School of Medicine
  • Columbia University
  • Weill Cornell Medical College
  • University of Rochester
  • Duke University Medical Center
  • University of Cincinnati Medical Center
  • University of Cincinnati
  • Cleveland Clinic
  • Ohio State University
  • Miami Valley Hospital
  • The Oregon Clinic, PC
  • University of Pennsylvania
  • Thomas Jefferson University Hospital
  • Temple University Hospital, Temple Lung Center
  • University of Pittsburgh Presbyterian - Montefiore
  • Medical University of South Carolina
  • Vanderbilt University Medical Center
  • Baylor College of Medicine
  • University of Utah
  • Inova Fairfax Hospital
  • Providence Everett Medical Center
  • University of Washington
  • Froedtert Hospital and Medical College of Wisconsin
  • Royal Prince Alfred Hospital
  • Concord Repatriation General Hospital
  • Saint Vincents Hospital
  • Mater Adult Hospital
  • Prince Charles Hospital
  • Royal Brisbane and Women's Hospital
  • Royal Adelaide Hospital
  • The Alfred Hospital
  • Sir Charles Gairdner Hospital
  • Royal Perth Hospital
  • ULB Erasme
  • Universitair Ziekenhuis Leuven
  • Cliniques Universitaires UCL de Mont-Godinne
  • Kelowna Respiratory and Allergy Clinic
  • Vancouver General Hospital
  • University of British Columbia
  • Saint Joseph's Healthcare
  • University Health Network
  • Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
  • Institut Universitaire de Cardiologie et de Pneumologie de Québec
  • Fakultní nemocnice Brno
  • Nemocnice Jihlava
  • Krajská nemocnice Liberec a.s.
  • Masarykova nemocnice v Ústí nad Labem o.z.
  • Fakultní Nemocnice Ostrava
  • Fakultní nemocnice Plzen
  • Thomayerova nemocnice
  • Hôpitaux Universitaires de Strasbourg
  • Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
  • Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
  • Centre Hospitalier Universitaire Hôpital Avicenne
  • HEGP
  • Hôpital Bichat-Claude Bernard
  • Hôpital Arnaud de Villeneuve
  • Hôpital Larrey, CHU de Toulouse, Service de Pneumologie
  • Hôpital Albert Calmette
  • Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
  • Centre Hospitalier Universitaire Hôpital Nord
  • Centre Hospitalier Universitaire Grenoble Hopital Michalon
  • Hôpital Louis Pradel
  • Universität Freiburg, Klinikum, Abt für Pneumologie
  • Thoraxklinik am Universitätsklinikum Heidelberg
  • Ruhrlandklinik
  • Klinikum Großhadern der Ludwig-Maximilians-Universität München
  • Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
  • Lungenfachklinik Immenhausen
  • Medizinische Hochschule Hannover
  • Fachkrankenhaus Coswig
  • Universitätsklinikum Leipzig
  • Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
  • Soroka University Medical Center
  • Chaim Sheba Medical Center
  • Hadassah-Hebrew University Medical Center
  • Meir Medical Center
  • Rabin Medical Center
  • Tel Aviv Sourasky Medical Center
  • Ospedale "G.B.Morgagni - L. Pierantoni"
  • Azienda Ospedaliera San Gerardo di Monza
  • Policlinico Universitario di Catania
  • San Giuseppe Hospital, Dept. of Internal Medicine
  • Azienda Ospedaliero-Universitaria Policlinico di Modena
  • Università degli studi Federico II di Napoli
  • Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
  • Fondazione PTV - Policlinico Tor Vergata
  • Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
  • Soon Chun Hyang University Hospital Bucheon
  • Gachon University Gil Medical Center
  • Seoul National University Bundang Hospital
  • Samsung Medical Center
  • Seoul National University Hospital
  • Korea University Anam Hospital
  • Asan Medical Center
  • 10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
  • Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
  • Instytut Gruzlicy i Chorób Pluc
  • Uniwersyteckie Centrum Kliniczne
  • Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
  • Hospital Universitario Central de Asturias
  • Hospital Quirón Madrid
  • Hospital de la Santa Creu i Sant Pau
  • Hospital Universitario Vall d'Hebron
  • Hospital Clinic de Barcelona
  • Hospital Universitario La Princesa
  • Hospital Universitario Virgen del Rocio
  • Kantonsspital St. Gallen
  • Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
  • Universitätsspital Basel
  • Birmingham Heartlands Hospital
  • Southmead Hospital
  • Papworth Hospital
  • Castle Hill Hospital
  • Royal Devon and Exeter Hospital
  • Saint James's University Hospital
  • Glenfield Hospital
  • Aintree University Hospitals NHS Foundation Trust
  • Royal Brompton Hospital
  • University Hospital of South Manchester NHS Foundation Trust
  • Nottingham City Hospital
  • Churchill Hospital
  • Northern General Hospital
  • Southampton General Hospital
  • Royal Infirmary of Edinburgh
  • Glasgow Royal Infirmary

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Simtuzumab

Simtuzumab Placebo

Arm Description

Participants will receive simtuzumab for up to 254 weeks.

Participants will receive simtuzumab placebo for up to 254 weeks.

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
PFS Among the Participants With sLOXL2 ≥ 75th Percentile

Secondary Outcome Measures

Overall Survival (OS)
Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Relative Change From Baseline in FVC % Predicted
FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130 The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130. The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations. The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.

Full Information

First Posted
January 14, 2013
Last Updated
April 28, 2017
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01769196
Brief Title
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
RAINIER
Official Title
A Phase 2, Randomized, Double-Blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional

2. Study Status

Record Verification Date
April 2017
Overall Recruitment Status
Terminated
Why Stopped
The Study was terminated due to lack of efficacy.
Study Start Date
January 31, 2013 (Actual)
Primary Completion Date
February 23, 2016 (Actual)
Study Completion Date
February 23, 2016 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic, Pulmonary, Fibrosis, IPF

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
544 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Simtuzumab
Arm Type
Experimental
Arm Description
Participants will receive simtuzumab for up to 254 weeks.
Arm Title
Simtuzumab Placebo
Arm Type
Placebo Comparator
Arm Description
Participants will receive simtuzumab placebo for up to 254 weeks.
Intervention Type
Drug
Intervention Name(s)
Simtuzumab
Other Intervention Name(s)
GS-6624
Intervention Description
125 mg/mL single-dose vials administered subcutaneously once a week
Intervention Type
Drug
Intervention Name(s)
Simtuzumab placebo
Intervention Description
Simtuzumab placebo single-dose vials administered subcutaneously once a week
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival (PFS) was defined as the categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC from baseline) with confirmation at a consecutive visit at least 2 weeks later using the same criteria.
Time Frame
Up to 148 weeks
Title
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
Time Frame
Up to 148 weeks
Title
PFS Among the Participants With sLOXL2 ≥ 75th Percentile
Time Frame
Up to 148 weeks
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Description
Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Time Frame
Up to 151 weeks
Title
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Time Frame
Up to 151 weeks
Title
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Time Frame
Up to 151 weeks
Title
Relative Change From Baseline in FVC % Predicted
Description
FVC was defined as the volume of air (liters) that can forcibly be blown out after taking a full breath. FVC % predicted was defined as FVC % of the participant divided by the average FVC % in the population for any person of similar age, sex, and body composition. Adjusted means were from mixed model repeated measures (MMRM) model with baseline FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130 The relative change was calculated as 100% * ( value at later time point minus value at baseline ) / value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Time Frame
Weeks 54, 106, and 130
Title
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Time Frame
Up to 148 weeks
Title
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Time Frame
Up to 148 weeks
Title
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Time Frame
Up to 148 weeks
Title
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Description
Adjusted means were from MMRM model with baseline 6MWD, FVC % predicted, sLOXL2 level, concomitant pirfenidone/nintedanib use (never vs. ever), treatment, visit, and treatment-by-visit interaction terms, including all data up to Week 130. The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Time Frame
Weeks 58, 106, and 130
Title
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
Description
The SGRQ is a disease-specific questionnaire designed to measure impact on overall health, daily life, and perceived well-being in patients with obstructive airways disease. Patients respond to questions about symptoms (frequency & severity) and impact components (social functioning and psychological disturbances resulting from airways disease). Scores range from 0 to 100, with higher scores indicating more limitations. The absolute change was calculated as value at later time point minus value at baseline, with lower values indicating a decrease and higher values indicating an increase.
Time Frame
Week 58, 106, and 130

10. Eligibility

Sex
All
Minimum Age & Unit of Time
45 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Key Inclusion Criteria: Male or female subjects from 45 to 85 years of age Definite IPF within 3 years prior to screening Be able to walk at least 50 meters Key Exclusion Criteria: Significant diseases other than IPF Obstructive lung disease Aortic aneurysm greater than or equal to 3.5 cm in diameter Treatment with immunosuppressive, cytotoxic, or antifibrotic drugs < 28 days prior to randomization are not permitted. N-acetylcysteine is permitted provided the individual has been on a stable dose for > 4 weeks prior to screening Concomitant use of pirfenidone or nintedanib must be in accordance with the approved prescribing instructions in the country where the site is located Individuals actively listed for lung transplant are excluded. However individuals at transplant centers with long waiting times (greater than 1 year) may be permitted to enter the study after discussion with Medical Monitor. Note: Other protocol defined Inclusion/Exclusion criteria may apply.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294
Country
United States
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
Saint Joseph's Hospital and Medical Center
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85103
Country
United States
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
Mayo Clinic Arizona
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85259
Country
United States
Facility Name
The University of Arizona
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85724
Country
United States
Facility Name
University of California San Diego
City
La Jolla
State/Province
California
ZIP/Postal Code
92093
Country
United States
Facility Name
David Geffen School of Medicine at University of California, Los Angeles
City
Los Angeles
State/Province
California
ZIP/Postal Code
90024
Country
United States
Facility Name
University of California Davis Medical Center
City
Sacramento
State/Province
California
ZIP/Postal Code
95817
Country
United States
Facility Name
University of California San Francisco
City
San Francisco
State/Province
California
ZIP/Postal Code
94143
Country
United States
Facility Name
Sansum Clinic
City
Santa Barbara
State/Province
California
ZIP/Postal Code
93105
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
National Jewish Health
City
Denver
State/Province
Colorado
ZIP/Postal Code
80206
Country
United States
Facility Name
Yale University School of Medicine
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06150
Country
United States
Facility Name
Bay Area Chest Physicians
City
Clearwater
State/Province
Florida
ZIP/Postal Code
33756
Country
United States
Facility Name
University of Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32209
Country
United States
Facility Name
Mayo Clinic Florida
City
Jacksonville
State/Province
Florida
ZIP/Postal Code
32224
Country
United States
Facility Name
University of Miami
City
Miami
State/Province
Florida
ZIP/Postal Code
33136
Country
United States
Facility Name
Sarasota Memorial Hospital
City
Sarasota
State/Province
Florida
ZIP/Postal Code
34239
Country
United States
Facility Name
Tampa General Hospital
City
Tampa
State/Province
Florida
ZIP/Postal Code
33606
Country
United States
Facility Name
Cleveland Clinic Florida
City
Weston
State/Province
Florida
ZIP/Postal Code
33331
Country
United States
Facility Name
Emory University Hospital
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30322
Country
United States
Facility Name
Southeastern Lung Care
City
Decatur
State/Province
Georgia
ZIP/Postal Code
30033
Country
United States
Facility Name
Northwestern University
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60611
Country
United States
Facility Name
Rush University Medical Center
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60612
Country
United States
Facility Name
University of Chicago
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60637
Country
United States
Facility Name
Loyola University Medical Center
City
Maywood
State/Province
Illinois
ZIP/Postal Code
60153
Country
United States
Facility Name
Loess Hills Clinical Research Center
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
University of Iowa Hospitals and Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
Facility Name
Kentuckiana Pulmonary Associates
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
University of Louisville
City
Louisville
State/Province
Kentucky
ZIP/Postal Code
40202
Country
United States
Facility Name
Tulane University School of Medicine
City
New Orleans
State/Province
Louisiana
ZIP/Postal Code
70112
Country
United States
Facility Name
University of Maryland
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21201
Country
United States
Facility Name
Tufts University School of Medicine
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
Brigham and Women's Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02120
Country
United States
Facility Name
Beth Israel Deaconess Medical Center
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02215
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
Country
United States
Facility Name
Henry Ford Hospital
City
Detroit
State/Province
Michigan
ZIP/Postal Code
48124
Country
United States
Facility Name
University of Minnesota Medical Center
City
Minneapolis
State/Province
Minnesota
ZIP/Postal Code
55455
Country
United States
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States
Facility Name
CardioPulmonary Associates
City
Chesterfield
State/Province
Missouri
ZIP/Postal Code
63017
Country
United States
Facility Name
Saint Luke's Midwest Pulmonary Consultants
City
Kansas City
State/Province
Missouri
ZIP/Postal Code
64111
Country
United States
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
Facility Name
Dartmouth Hitchcock Medical Center
City
Lebanon
State/Province
New Hampshire
ZIP/Postal Code
55905
Country
United States
Facility Name
Robert Wood Johnson Medical School
City
New Brunswick
State/Province
New Jersey
ZIP/Postal Code
08903-0019
Country
United States
Facility Name
Pulmonary and Allergy Associates, PA
City
Summit
State/Province
New Jersey
ZIP/Postal Code
07901
Country
United States
Facility Name
Albany Medical College
City
Albany
State/Province
New York
ZIP/Postal Code
12208
Country
United States
Facility Name
Jamaica Hospital Medical Center
City
Jamaica
State/Province
New York
ZIP/Postal Code
11418
Country
United States
Facility Name
North Shore University Hospital
City
New Hyde Park
State/Province
New York
ZIP/Postal Code
11040
Country
United States
Facility Name
Mount Sinai School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10029
Country
United States
Facility Name
Columbia University
City
New York
State/Province
New York
ZIP/Postal Code
10032
Country
United States
Facility Name
Weill Cornell Medical College
City
New York
State/Province
New York
ZIP/Postal Code
10065
Country
United States
Facility Name
University of Rochester
City
Rochester
State/Province
New York
ZIP/Postal Code
14620
Country
United States
Facility Name
Duke University Medical Center
City
Durham
State/Province
North Carolina
ZIP/Postal Code
27710
Country
United States
Facility Name
University of Cincinnati Medical Center
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
University of Cincinnati
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45267
Country
United States
Facility Name
Cleveland Clinic
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
Ohio State University
City
Columbus
State/Province
Ohio
ZIP/Postal Code
43221
Country
United States
Facility Name
Miami Valley Hospital
City
Dayton
State/Province
Ohio
ZIP/Postal Code
45409
Country
United States
Facility Name
The Oregon Clinic, PC
City
Portland
State/Province
Oregon
ZIP/Postal Code
97220
Country
United States
Facility Name
University of Pennsylvania
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19104
Country
United States
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Facility Name
Temple University Hospital, Temple Lung Center
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19140
Country
United States
Facility Name
University of Pittsburgh Presbyterian - Montefiore
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Baylor College of Medicine
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Utah
City
Salt Lake City
State/Province
Utah
ZIP/Postal Code
84108
Country
United States
Facility Name
Inova Fairfax Hospital
City
Falls Church
State/Province
Virginia
ZIP/Postal Code
22042
Country
United States
Facility Name
Providence Everett Medical Center
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
Froedtert Hospital and Medical College of Wisconsin
City
Milwaukee
State/Province
Wisconsin
ZIP/Postal Code
53226
Country
United States
Facility Name
Royal Prince Alfred Hospital
City
Camperdown
State/Province
New South Wales
ZIP/Postal Code
2050
Country
Australia
Facility Name
Concord Repatriation General Hospital
City
Concord
State/Province
New South Wales
ZIP/Postal Code
2139
Country
Australia
Facility Name
Saint Vincents Hospital
City
Darlinghurst
State/Province
New South Wales
ZIP/Postal Code
2010
Country
Australia
Facility Name
Mater Adult Hospital
City
Brisbane
State/Province
Queensland
ZIP/Postal Code
4000
Country
Australia
Facility Name
Prince Charles Hospital
City
Chermside
State/Province
Queensland
ZIP/Postal Code
4032
Country
Australia
Facility Name
Royal Brisbane and Women's Hospital
City
Herston
State/Province
Queensland
ZIP/Postal Code
4029
Country
Australia
Facility Name
Royal Adelaide Hospital
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
Facility Name
The Alfred Hospital
City
Melbourne
State/Province
Victoria
ZIP/Postal Code
3004
Country
Australia
Facility Name
Sir Charles Gairdner Hospital
City
Nedlands
State/Province
Western Australia
ZIP/Postal Code
6009
Country
Australia
Facility Name
Royal Perth Hospital
City
Perth
State/Province
Western Australia
ZIP/Postal Code
6000
Country
Australia
Facility Name
ULB Erasme
City
Anderlecht
State/Province
Brussels
ZIP/Postal Code
1070
Country
Belgium
Facility Name
Universitair Ziekenhuis Leuven
City
Leuven
State/Province
Flemish Brabant
ZIP/Postal Code
3000
Country
Belgium
Facility Name
Cliniques Universitaires UCL de Mont-Godinne
City
Yvoir
State/Province
Namur
ZIP/Postal Code
5530
Country
Belgium
Facility Name
Kelowna Respiratory and Allergy Clinic
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y1E4
Country
Canada
Facility Name
Vancouver General Hospital
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V5Z 1M9
Country
Canada
Facility Name
University of British Columbia
City
Vancouver
State/Province
British Columbia
ZIP/Postal Code
V6Z 1Y6
Country
Canada
Facility Name
Saint Joseph's Healthcare
City
Hamilton
State/Province
Ontario
ZIP/Postal Code
L8N 4A6
Country
Canada
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G2C4
Country
Canada
Facility Name
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2W 1T8
Country
Canada
Facility Name
Institut Universitaire de Cardiologie et de Pneumologie de Québec
City
Quebec City
State/Province
Quebec
ZIP/Postal Code
G1V4G5
Country
Canada
Facility Name
Fakultní nemocnice Brno
City
Brno
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
625 00
Country
Czechia
Facility Name
Nemocnice Jihlava
City
Jihlava
State/Province
Jihormoravsky Kraj
ZIP/Postal Code
689 32
Country
Czechia
Facility Name
Krajská nemocnice Liberec a.s.
City
Liberec
State/Province
Severocesky Kraj
ZIP/Postal Code
460 63
Country
Czechia
Facility Name
Masarykova nemocnice v Ústí nad Labem o.z.
City
Ústí nad Labem
State/Province
Severocesky Kraj
ZIP/Postal Code
401 13
Country
Czechia
Facility Name
Fakultní Nemocnice Ostrava
City
Ostrava - Poruba
State/Province
Severomoravsky Kraj
ZIP/Postal Code
708 52
Country
Czechia
Facility Name
Fakultní nemocnice Plzen
City
Plzen
State/Province
Zapadocesky Kraj
ZIP/Postal Code
305 99
Country
Czechia
Facility Name
Thomayerova nemocnice
City
Prague 4 - Krc
ZIP/Postal Code
140 59
Country
Czechia
Facility Name
Hôpitaux Universitaires de Strasbourg
City
Strasbourg
State/Province
Alsace
ZIP/Postal Code
67091
Country
France
Facility Name
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
City
Rennes cedex 9
State/Province
Bretagne
ZIP/Postal Code
35033
Country
France
Facility Name
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
City
Tours Cedex 9
State/Province
Centre
ZIP/Postal Code
37044
Country
France
Facility Name
Centre Hospitalier Universitaire Hôpital Avicenne
City
Bobigny Cedex
State/Province
Ile-de-france
ZIP/Postal Code
93009
Country
France
Facility Name
HEGP
City
Paris Cedex 15
State/Province
Ile-de-france
ZIP/Postal Code
75908
Country
France
Facility Name
Hôpital Bichat-Claude Bernard
City
Paris
State/Province
Ile-de-france
ZIP/Postal Code
75018
Country
France
Facility Name
Hôpital Arnaud de Villeneuve
City
Montpellier cedex 5
State/Province
Languedoc-roussillon
ZIP/Postal Code
34295
Country
France
Facility Name
Hôpital Larrey, CHU de Toulouse, Service de Pneumologie
City
Toulouse cedex 9
State/Province
Midi-pyrenees
ZIP/Postal Code
31059
Country
France
Facility Name
Hôpital Albert Calmette
City
Lille cedex
State/Province
Nord Pas-de-calais
ZIP/Postal Code
59037
Country
France
Facility Name
Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
City
Nice CEDEX 1
State/Province
Poitou-charentes
ZIP/Postal Code
06002
Country
France
Facility Name
Centre Hospitalier Universitaire Hôpital Nord
City
Marseille Cedex 20
State/Province
Provence Alpes Cote D'azur
ZIP/Postal Code
13015
Country
France
Facility Name
Centre Hospitalier Universitaire Grenoble Hopital Michalon
City
Grenoble Cedex 9
State/Province
Rhone-Alpes
ZIP/Postal Code
38043
Country
France
Facility Name
Hôpital Louis Pradel
City
Bron
State/Province
Rhone-aples
ZIP/Postal Code
69677
Country
France
Facility Name
Universität Freiburg, Klinikum, Abt für Pneumologie
City
Freiburg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
79106
Country
Germany
Facility Name
Thoraxklinik am Universitätsklinikum Heidelberg
City
Heidelberg
State/Province
Baden-wuerttemberg
ZIP/Postal Code
69126
Country
Germany
Facility Name
Ruhrlandklinik
City
Mannheim
State/Province
Baden-wuerttemberg
ZIP/Postal Code
68165
Country
Germany
Facility Name
Klinikum Großhadern der Ludwig-Maximilians-Universität München
City
München
State/Province
Bayern
ZIP/Postal Code
81377
Country
Germany
Facility Name
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
City
Giessen
State/Province
Hessen
ZIP/Postal Code
35392
Country
Germany
Facility Name
Lungenfachklinik Immenhausen
City
Immenhausen
State/Province
Hessen
ZIP/Postal Code
34376
Country
Germany
Facility Name
Medizinische Hochschule Hannover
City
Hanover
State/Province
Niedersachsen
ZIP/Postal Code
30625
Country
Germany
Facility Name
Fachkrankenhaus Coswig
City
Coswig
State/Province
Sachsen
ZIP/Postal Code
01640
Country
Germany
Facility Name
Universitätsklinikum Leipzig
City
Leipzig
State/Province
Sachsen
ZIP/Postal Code
04103
Country
Germany
Facility Name
Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
City
Berlin
ZIP/Postal Code
14165
Country
Germany
Facility Name
Soroka University Medical Center
City
Beer Sheva
State/Province
Beersheba
ZIP/Postal Code
84100
Country
Israel
Facility Name
Chaim Sheba Medical Center
City
Tel Hashomer
State/Province
Tel Aviv
ZIP/Postal Code
52621
Country
Israel
Facility Name
Hadassah-Hebrew University Medical Center
City
Jerusalem
ZIP/Postal Code
91120
Country
Israel
Facility Name
Meir Medical Center
City
Kfar Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
Rabin Medical Center
City
Petach Tikvah
ZIP/Postal Code
49100
Country
Israel
Facility Name
Tel Aviv Sourasky Medical Center
City
Tel Aviv
ZIP/Postal Code
64239
Country
Israel
Facility Name
Ospedale "G.B.Morgagni - L. Pierantoni"
City
Forlì
State/Province
Forli-cesena
ZIP/Postal Code
47100
Country
Italy
Facility Name
Azienda Ospedaliera San Gerardo di Monza
City
Monza
State/Province
Monza E Brianza
ZIP/Postal Code
20052
Country
Italy
Facility Name
Policlinico Universitario di Catania
City
Catania
ZIP/Postal Code
95123
Country
Italy
Facility Name
San Giuseppe Hospital, Dept. of Internal Medicine
City
Milano
ZIP/Postal Code
20132
Country
Italy
Facility Name
Azienda Ospedaliero-Universitaria Policlinico di Modena
City
Modena
ZIP/Postal Code
41100
Country
Italy
Facility Name
Università degli studi Federico II di Napoli
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Facility Name
Fondazione PTV - Policlinico Tor Vergata
City
Roma
ZIP/Postal Code
00133
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
City
Siena
ZIP/Postal Code
53100
Country
Italy
Facility Name
Soon Chun Hyang University Hospital Bucheon
City
Bucheon-si
State/Province
Gyeonggi-do
ZIP/Postal Code
420-767
Country
Korea, Republic of
Facility Name
Gachon University Gil Medical Center
City
Incheon
State/Province
Gyeonggi-Do
ZIP/Postal Code
405-760
Country
Korea, Republic of
Facility Name
Seoul National University Bundang Hospital
City
Seongnam-si
State/Province
Gyeonggi-do
ZIP/Postal Code
463-707
Country
Korea, Republic of
Facility Name
Samsung Medical Center
City
Seoul
State/Province
Gyeonggi-do
ZIP/Postal Code
135-710
Country
Korea, Republic of
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
110-744
Country
Korea, Republic of
Facility Name
Korea University Anam Hospital
City
Seoul
ZIP/Postal Code
136-705
Country
Korea, Republic of
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
138-736
Country
Korea, Republic of
Facility Name
10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
City
Bydgoszcz
State/Province
Kujawsko-pomorskie
ZIP/Postal Code
85-681
Country
Poland
Facility Name
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
City
Lódz
State/Province
Lodzkie
ZIP/Postal Code
90-153
Country
Poland
Facility Name
Instytut Gruzlicy i Chorób Pluc
City
Warszawa
State/Province
Mazowieckie
ZIP/Postal Code
01-138
Country
Poland
Facility Name
Uniwersyteckie Centrum Kliniczne
City
Gdansk
State/Province
Pomorskie
ZIP/Postal Code
80-952
Country
Poland
Facility Name
Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
City
Zabrze
State/Province
Slaskie
ZIP/Postal Code
41-803
Country
Poland
Facility Name
Hospital Universitario Central de Asturias
City
Oviedo
State/Province
Asturias
ZIP/Postal Code
33011
Country
Spain
Facility Name
Hospital Quirón Madrid
City
Pozuelo de Alarcón
State/Province
Madrid
ZIP/Postal Code
28223
Country
Spain
Facility Name
Hospital de la Santa Creu i Sant Pau
City
Barcelona
ZIP/Postal Code
08025
Country
Spain
Facility Name
Hospital Universitario Vall d'Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Facility Name
Hospital Clinic de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Facility Name
Hospital Universitario La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Facility Name
Hospital Universitario Virgen del Rocio
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Facility Name
Kantonsspital St. Gallen
City
St. Gallen
State/Province
Sankt Gallen
ZIP/Postal Code
9007
Country
Switzerland
Facility Name
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
City
Lausanne
State/Province
Vaud
ZIP/Postal Code
CH 1011
Country
Switzerland
Facility Name
Universitätsspital Basel
City
Basel
ZIP/Postal Code
4031
Country
Switzerland
Facility Name
Birmingham Heartlands Hospital
City
Birmingham
State/Province
England
ZIP/Postal Code
B9 5SS
Country
United Kingdom
Facility Name
Southmead Hospital
City
Bristol
State/Province
England
ZIP/Postal Code
BS10 5NB
Country
United Kingdom
Facility Name
Papworth Hospital
City
Cambridge
State/Province
England
ZIP/Postal Code
CB23 3RE
Country
United Kingdom
Facility Name
Castle Hill Hospital
City
Cottingham
State/Province
England
ZIP/Postal Code
HU16 5JQ
Country
United Kingdom
Facility Name
Royal Devon and Exeter Hospital
City
Exeter
State/Province
England
ZIP/Postal Code
EX2 5DW
Country
United Kingdom
Facility Name
Saint James's University Hospital
City
Leeds
State/Province
England
ZIP/Postal Code
LS9 7TF
Country
United Kingdom
Facility Name
Glenfield Hospital
City
Leicester
State/Province
England
ZIP/Postal Code
LE3 9QP
Country
United Kingdom
Facility Name
Aintree University Hospitals NHS Foundation Trust
City
Liverpool
State/Province
England
ZIP/Postal Code
L9 7AL
Country
United Kingdom
Facility Name
Royal Brompton Hospital
City
London
State/Province
England
ZIP/Postal Code
SW3 6NP
Country
United Kingdom
Facility Name
University Hospital of South Manchester NHS Foundation Trust
City
Manchester
State/Province
England
ZIP/Postal Code
M23 9LT
Country
United Kingdom
Facility Name
Nottingham City Hospital
City
Nottingham
State/Province
England
ZIP/Postal Code
NG5 1PD
Country
United Kingdom
Facility Name
Churchill Hospital
City
Oxford
State/Province
England
ZIP/Postal Code
OX3 7LE
Country
United Kingdom
Facility Name
Northern General Hospital
City
Sheffield
State/Province
England
ZIP/Postal Code
S5 7AU
Country
United Kingdom
Facility Name
Southampton General Hospital
City
Southampton
State/Province
England
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
Royal Infirmary of Edinburgh
City
Edinburgh
State/Province
Scotland
ZIP/Postal Code
EH16 4TJ
Country
United Kingdom
Facility Name
Glasgow Royal Infirmary
City
Glasgow
State/Province
Scotland
ZIP/Postal Code
G11 6NT
Country
United Kingdom

12. IPD Sharing Statement

Citations:
PubMed Identifier
27939076
Citation
Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.
Results Reference
background
Citation
Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.
Results Reference
result
Citation
Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.
Results Reference
result
Citation
Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.
Results Reference
result

Learn more about this trial

Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)

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