Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
NCT ID: NCT01769196
Last Updated: 2017-05-30
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
544 participants
INTERVENTIONAL
2013-01-31
2016-02-23
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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Simtuzumab
Participants will receive simtuzumab for up to 254 weeks.
Simtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week
Simtuzumab Placebo
Participants will receive simtuzumab placebo for up to 254 weeks.
Simtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week
Interventions
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Simtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week
Simtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* Definite IPF within 3 years prior to screening
* Be able to walk at least 50 meters
Exclusion Criteria
* 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.
45 Years
85 Years
ALL
No
Sponsors
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Gilead Sciences
INDUSTRY
Responsible Party
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Principal Investigators
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Gilead Study Director
Role: STUDY_DIRECTOR
Gilead Sciences
Locations
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University of Alabama at Birmingham
Birmingham, Alabama, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States
Mayo Clinic Arizona
Scottsdale, Arizona, United States
The University of Arizona
Tucson, Arizona, United States
University of California San Diego
La Jolla, California, United States
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California, United States
University of California Davis Medical Center
Sacramento, California, United States
University of California San Francisco
San Francisco, California, United States
Sansum Clinic
Santa Barbara, California, United States
Stanford University Medical Center
Stanford, California, United States
National Jewish Health
Denver, Colorado, United States
Yale University School of Medicine
New Haven, Connecticut, United States
Bay Area Chest Physicians
Clearwater, Florida, United States
University of Florida
Jacksonville, Florida, United States
Mayo Clinic Florida
Jacksonville, Florida, United States
University of Miami
Miami, Florida, United States
Sarasota Memorial Hospital
Sarasota, Florida, United States
Tampa General Hospital
Tampa, Florida, United States
Cleveland Clinic Florida
Weston, Florida, United States
Emory University Hospital
Atlanta, Georgia, United States
Southeastern Lung Care
Decatur, Georgia, United States
Northwestern University
Chicago, Illinois, United States
Rush University Medical Center
Chicago, Illinois, United States
University of Chicago
Chicago, Illinois, United States
Loyola University Medical Center
Maywood, Illinois, United States
Loess Hills Clinical Research Center
Council Bluffs, Iowa, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky, United States
University of Louisville
Louisville, Kentucky, United States
Tulane University School of Medicine
New Orleans, Louisiana, United States
University of Maryland
Baltimore, Maryland, United States
Tufts University School of Medicine
Boston, Massachusetts, United States
Brigham and Women's Hospital
Boston, Massachusetts, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan, United States
University of Minnesota Medical Center
Minneapolis, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
CardioPulmonary Associates
Chesterfield, Missouri, United States
Saint Luke's Midwest Pulmonary Consultants
Kansas City, Missouri, United States
Washington University School of Medicine
St Louis, Missouri, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey, United States
Pulmonary and Allergy Associates, PA
Summit, New Jersey, United States
Albany Medical College
Albany, New York, United States
Jamaica Hospital Medical Center
Jamaica, New York, United States
North Shore University Hospital
New Hyde Park, New York, United States
Mount Sinai School of Medicine
New York, New York, United States
Columbia University
New York, New York, United States
Weill Cornell Medical College
New York, New York, United States
University of Rochester
Rochester, New York, United States
Duke University Medical Center
Durham, North Carolina, United States
University of Cincinnati Medical Center
Cincinnati, Ohio, United States
University of Cincinnati
Cincinnati, Ohio, United States
Cleveland Clinic
Cleveland, Ohio, United States
Ohio State University
Columbus, Ohio, United States
Miami Valley Hospital
Dayton, Ohio, United States
The Oregon Clinic, PC
Portland, Oregon, United States
University of Pennsylvania
Philadelphia, Pennsylvania, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania, United States
Temple University Hospital, Temple Lung Center
Philadelphia, Pennsylvania, United States
University of Pittsburgh Presbyterian - Montefiore
Pittsburgh, Pennsylvania, United States
Medical University of South Carolina
Charleston, South Carolina, United States
Vanderbilt University Medical Center
Nashville, Tennessee, United States
Baylor College of Medicine
Houston, Texas, United States
University of Utah
Salt Lake City, Utah, United States
Inova Fairfax Hospital
Falls Church, Virginia, United States
Providence Everett Medical Center
Everett, Washington, United States
University of Washington
Seattle, Washington, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia
Concord Repatriation General Hospital
Concord, New South Wales, Australia
Saint Vincents Hospital
Darlinghurst, New South Wales, Australia
Mater Adult Hospital
Brisbane, Queensland, Australia
Prince Charles Hospital
Chermside, Queensland, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland, Australia
Royal Adelaide Hospital
Adelaide, South Australia, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia, Australia
Royal Perth Hospital
Perth, Western Australia, Australia
ULB Erasme
Anderlecht, Brussels Capital, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur, Belgium
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia, Canada
Vancouver General Hospital
Vancouver, British Columbia, Canada
University of British Columbia
Vancouver, British Columbia, Canada
Saint Joseph's Healthcare
Hamilton, Ontario, Canada
University Health Network
Toronto, Ontario, Canada
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
Montreal, Quebec, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec, Quebec, Canada
Fakultní nemocnice Brno
Brno, Jihormoravsky Kraj, Czechia
Nemocnice Jihlava
Jihlava, Jihormoravsky Kraj, Czechia
Krajská nemocnice Liberec a.s.
Liberec, Severocesky Kraj, Czechia
Masarykova nemocnice v Ústí nad Labem o.z.
Ústí nad Labem, Severocesky Kraj, Czechia
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky Kraj, Czechia
Fakultní nemocnice Plzen
Pilsen, Zapadocesky Kraj, Czechia
Thomayerova nemocnice
Prague 4 - Krc, , Czechia
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace, France
Centre Hospitalier Universitaire Grenoble Hopital Michalon
Grenoble, Auvergne-Rhône-Alpes, France
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
Rennes, Brittany Region, France
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
Tours, Centre-Val de Loire, France
Hôpital Albert Calmette
Lille, Hauts-de-France, France
Hôpital Arnaud de Villeneuve
Montpellier, Languedoc-roussillon, France
Hôpital Larrey, CHU de Toulouse, Service de Pneumologie
Toulouse, Midi-pyrenees, France
Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
Nice, Poitou-charentes, France
Centre Hospitalier Universitaire Hôpital Nord
Marseille, Provence-Alpes-Côte d'Azur Region, France
Hôpital Louis Pradel
Bron, Rhone-aples, France
Centre Hospitalier Universitaire Hôpital Avicenne
Bobigny, Île-de-France Region, France
Hôpital Bichat-Claude Bernard
Paris, Île-de-France Region, France
HEGP
Paris, Île-de-France Region, France
Universität Freiburg, Klinikum, Abt für Pneumologie
Freiburg im Breisgau, Baden-Wurttemberg, Germany
Thoraxklinik am Universitätsklinikum Heidelberg
Heidelberg, Baden-Wurttemberg, Germany
Ruhrlandklinik
Mannheim, Baden-Wurttemberg, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität München
München, Bavaria, Germany
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
Giessen, Hesse, Germany
Lungenfachklinik Immenhausen
Immenhausen, Hesse, Germany
Medizinische Hochschule Hannover
Hanover, Lower Saxony, Germany
Fachkrankenhaus Coswig
Coswig, Saxony, Germany
Universitätsklinikum Leipzig
Leipzig, Saxony, Germany
Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
Berlin, , Germany
Soroka University Medical Center
Beersheba, Beersheba, Israel
Chaim Sheba Medical Center
Tel Litwinsky, Tel Aviv, Israel
Hadassah-Hebrew University Medical Center
Jerusalem, , Israel
Meir Medical Center
Kfar Saba, , Israel
Rabin Medical Center
Petach Tikvah, , Israel
Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Ospedale "G.B.Morgagni - L. Pierantoni"
Forlì, Forli-cesena, Italy
Azienda Ospedaliera San Gerardo di Monza
Monza, Monza E Brianza, Italy
Policlinico Universitario di Catania
Catania, , Italy
San Giuseppe Hospital, Dept. of Internal Medicine
Milan, , Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
Modena, , Italy
Università degli studi Federico II di Napoli
Napoli, , Italy
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
Palermo, , Italy
Fondazione PTV - Policlinico Tor Vergata
Roma, , Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
Siena, , Italy
10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland
Instytut Gruzlicy i Chorób Pluc
Warsaw, Masovian Voivodeship, Poland
Uniwersyteckie Centrum Kliniczne
Gdansk, Pomeranian Voivodeship, Poland
Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
Zabrze, Silesian Voivodeship, Poland
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
Lódz, Łódź Voivodeship, Poland
Soon Chun Hyang University Hospital Bucheon
Bucheon-si, Gyeonggi-do, South Korea
Gachon University Gil Medical Center
Incheon, Gyeonggi-do, South Korea
Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
Samsung Medical Center
Seoul, Gyeonggi-do, South Korea
Seoul National University Hospital
Seoul, , South Korea
Korea University Anam Hospital
Seoul, , South Korea
Asan Medical Center
Seoul, , South Korea
Hospital Quirón Madrid
Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Central de Asturias
Oviedo, Principality of Asturias, Spain
Hospital de la Santa Creu i Sant Pau
Barcelona, , Spain
Hospital Universitario Vall d'Hebron
Barcelona, , Spain
Hospital Clinic de Barcelona
Barcelona, , Spain
Hospital Universitario La Princesa
Madrid, , Spain
Hospital Universitario Virgen del Rocio
Seville, , Spain
Kantonsspital St. Gallen
Sankt Gallen, Canton of St. Gallen, Switzerland
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
Lausanne, Canton of Vaud, Switzerland
Universitätsspital Basel
Basel, , Switzerland
Birmingham Heartlands Hospital
Birmingham, England, United Kingdom
Southmead Hospital
Bristol, England, United Kingdom
Papworth Hospital
Cambridge, England, United Kingdom
Castle Hill Hospital
Cottingham, England, United Kingdom
Royal Devon and Exeter Hospital
Exeter, England, United Kingdom
Saint James's University Hospital
Leeds, England, United Kingdom
Glenfield Hospital
Leicester, England, United Kingdom
Aintree University Hospitals NHS Foundation Trust
Liverpool, England, United Kingdom
Royal Brompton Hospital
London, England, United Kingdom
University Hospital of South Manchester NHS Foundation Trust
Manchester, England, United Kingdom
Nottingham City Hospital
Nottingham, England, United Kingdom
Churchill Hospital
Oxford, England, United Kingdom
Northern General Hospital
Sheffield, England, United Kingdom
Southampton General Hospital
Southampton, England, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, United Kingdom
Glasgow Royal Infirmary
Glasgow, Scotland, United Kingdom
Countries
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References
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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.
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.
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.
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.
Other Identifiers
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2012-001571-36
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
GS-US-322-0207
Identifier Type: -
Identifier Source: org_study_id
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