Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
- Conditions
- Idiopathic Pulmonary Fibrosis
- Interventions
- Registration Number
- NCT01769196
- Lead Sponsor
- Gilead Sciences
- 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- All
- Target Recruitment
- 544
- 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
-
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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Simtuzumab Placebo Simtuzumab placebo Participants will receive simtuzumab placebo for up to 254 weeks. Simtuzumab Simtuzumab Participants will receive simtuzumab for up to 254 weeks.
- Primary Outcome Measures
Name Time Method Progression Free Survival Up to 148 weeks 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 Up to 148 weeks PFS Among the Participants With sLOXL2 ≥ 75th Percentile Up to 148 weeks
- Secondary Outcome Measures
Name Time Method Overall Survival (OS) Up to 151 weeks 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 Up to 151 weeks Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile Up to 151 weeks Relative Change From Baseline in FVC % Predicted Weeks 54, 106, and 130 * 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 Up to 148 weeks Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations Up to 148 weeks Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death Up to 148 weeks Absolute Change From Baseline in 6 Minute Walk Distance (6MWD) Weeks 58, 106, and 130 * 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 Week 58, 106, and 130 * 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.
Trial Locations
- Locations (174)
Sarasota Memorial Hospital
🇺🇸Sarasota, Florida, United States
University of Maryland
🇺🇸Baltimore, Maryland, United States
University of Chicago
🇺🇸Chicago, Illinois, United States
Cleveland Clinic
🇺🇸Cleveland, Ohio, United States
Ohio State University
🇺🇸Columbus, Ohio, United States
University Hospital of South Manchester NHS Foundation Trust
🇬🇧Manchester, England, United Kingdom
HEGP
🇫🇷Paris Cedex 15, Ile-de-france, France
Universitätsklinikum Leipzig
🇩🇪Leipzig, Sachsen, Germany
University of Miami
🇺🇸Miami, Florida, United States
Baylor College of Medicine
🇺🇸Houston, Texas, United States
University of Cincinnati Medical Center
🇺🇸Cincinnati, Ohio, United States
University of Cincinnati
🇺🇸Cincinnati, Ohio, United States
Cliniques Universitaires UCL de Mont-Godinne
🇧🇪Yvoir, Namur, Belgium
Royal Perth Hospital
🇦🇺Perth, Western Australia, Australia
University of Florida
🇺🇸Jacksonville, Florida, United States
Brigham and Women's Hospital
🇺🇸Boston, Massachusetts, United States
Arizona Pulmonary Specialists, Ltd.
🇺🇸Scottsdale, Arizona, United States
The University of Arizona
🇺🇸Tucson, Arizona, United States
Albany Medical College
🇺🇸Albany, New York, United States
Beth Israel Deaconess Medical Center
🇺🇸Boston, Massachusetts, United States
University of Washington
🇺🇸Seattle, Washington, United States
Weill Cornell Medical College
🇺🇸New York, New York, United States
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, Alsace, France
Instytut Gruzlicy i Chorób Pluc
🇵🇱Warszawa, Mazowieckie, Poland
Tulane University School of Medicine
🇺🇸New Orleans, Louisiana, United States
The Alfred Hospital
🇦🇺Melbourne, Victoria, Australia
Jamaica Hospital Medical Center
🇺🇸Jamaica, New York, United States
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States
Medical University of South Carolina
🇺🇸Charleston, South Carolina, United States
Robert Wood Johnson Medical School
🇺🇸New Brunswick, New Jersey, United States
Institut Universitaire de Cardiologie et de Pneumologie de Québec
🇨🇦Quebec City, Quebec, Canada
Dartmouth Hitchcock Medical Center
🇺🇸Lebanon, New Hampshire, United States
Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach
🇵🇱Zabrze, Slaskie, Poland
Pulmonary and Allergy Associates, PA
🇺🇸Summit, New Jersey, United States
Hospital Universitario Central de Asturias
🇪🇸Oviedo, Asturias, Spain
Kantonsspital St. Gallen
🇨🇭St. Gallen, Sankt Gallen, Switzerland
Vancouver General Hospital
🇨🇦Vancouver, British Columbia, Canada
Rabin Medical Center
🇮🇱Petach Tikvah, Israel
Kelowna Respiratory and Allergy Clinic
🇨🇦Kelowna, British Columbia, Canada
Universitair Ziekenhuis Leuven
🇧🇪Leuven, Flemish Brabant, Belgium
Southmead Hospital
🇬🇧Bristol, England, United Kingdom
Northern General Hospital
🇬🇧Sheffield, England, United Kingdom
Southampton General Hospital
🇬🇧Southampton, England, United Kingdom
University of Alabama at Birmingham
🇺🇸Birmingham, Alabama, United States
National Jewish Health
🇺🇸Denver, Colorado, United States
The Oregon Clinic, PC
🇺🇸Portland, Oregon, United States
Saint Joseph's Hospital and Medical Center
🇺🇸Phoenix, Arizona, United States
University of California San Francisco
🇺🇸San Francisco, California, United States
Henry Ford Hospital
🇺🇸Detroit, Michigan, United States
University of Minnesota Medical Center
🇺🇸Minneapolis, Minnesota, United States
Vanderbilt University Medical Center
🇺🇸Nashville, Tennessee, United States
University of Utah
🇺🇸Salt Lake City, Utah, United States
Mayo Clinic
🇺🇸Rochester, Minnesota, United States
Tampa General Hospital
🇺🇸Tampa, Florida, United States
Froedtert Hospital and Medical College of Wisconsin
🇺🇸Milwaukee, Wisconsin, United States
University Health Network
🇨🇦Toronto, Ontario, Canada
Mayo Clinic Arizona
🇺🇸Scottsdale, Arizona, United States
Southeastern Lung Care
🇺🇸Decatur, Georgia, United States
Tufts University School of Medicine
🇺🇸Boston, Massachusetts, United States
Sansum Clinic
🇺🇸Santa Barbara, California, United States
Loess Hills Clinical Research Center
🇺🇸Council Bluffs, Iowa, United States
Rush University Medical Center
🇺🇸Chicago, Illinois, United States
Saint Luke's Midwest Pulmonary Consultants
🇺🇸Kansas City, Missouri, United States
CardioPulmonary Associates
🇺🇸Chesterfield, Missouri, United States
Washington University School of Medicine
🇺🇸Saint Louis, Missouri, United States
Columbia University
🇺🇸New York, New York, United States
Saint Vincents Hospital
🇦🇺Darlinghurst, New South Wales, Australia
Prince Charles Hospital
🇦🇺Chermside, Queensland, Australia
University of Rochester
🇺🇸Rochester, New York, United States
Miami Valley Hospital
🇺🇸Dayton, Ohio, United States
University of Pennsylvania
🇺🇸Philadelphia, Pennsylvania, United States
University of Pittsburgh Presbyterian - Montefiore
🇺🇸Pittsburgh, Pennsylvania, United States
Temple University Hospital, Temple Lung Center
🇺🇸Philadelphia, Pennsylvania, United States
Concord Repatriation General Hospital
🇦🇺Concord, New South Wales, Australia
Sir Charles Gairdner Hospital
🇦🇺Nedlands, Western Australia, Australia
Providence Everett Medical Center
🇺🇸Everett, Washington, United States
Royal Brisbane and Women's Hospital
🇦🇺Herston, Queensland, Australia
Mater Adult Hospital
🇦🇺Brisbane, Queensland, Australia
ULB Erasme
🇧🇪Anderlecht, Brussels, Belgium
Royal Adelaide Hospital
🇦🇺Adelaide, South Australia, Australia
Saint Joseph's Healthcare
🇨🇦Hamilton, Ontario, Canada
University of British Columbia
🇨🇦Vancouver, British Columbia, Canada
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
🇨🇦Montreal, Quebec, Canada
Krajská nemocnice Liberec a.s.
🇨🇿Liberec, Severocesky Kraj, Czechia
Hôpital Albert Calmette
🇫🇷Lille cedex, Nord Pas-de-calais, France
Masarykova nemocnice v Ústí nad Labem o.z.
🇨🇿Ústí nad Labem, Severocesky Kraj, Czechia
Hôpital Larrey, CHU de Toulouse, Service de Pneumologie
🇫🇷Toulouse cedex 9, Midi-pyrenees, France
Centre Hospitalier Universitaire Hôpital Nord
🇫🇷Marseille Cedex 20, Provence Alpes Cote D'azur, France
Fakultní nemocnice Brno
🇨🇿Brno, Jihormoravsky Kraj, Czechia
Chaim Sheba Medical Center
🇮🇱Tel Hashomer, Tel Aviv, Israel
Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau
🇫🇷Tours Cedex 9, Centre, France
Centre Hospitalier Universitaire Hôpital Avicenne
🇫🇷Bobigny Cedex, Ile-de-france, France
Hôpital Louis Pradel
🇫🇷Bron, Rhone-aples, France
Nemocnice Jihlava
🇨🇿Jihlava, Jihormoravsky Kraj, Czechia
Thomayerova nemocnice
🇨🇿Prague 4 - Krc, Czechia
Ospedale "G.B.Morgagni - L. Pierantoni"
🇮🇹Forlì, Forli-cesena, Italy
San Giuseppe Hospital, Dept. of Internal Medicine
🇮🇹Milano, Italy
Hôpital Arnaud de Villeneuve
🇫🇷Montpellier cedex 5, Languedoc-roussillon, France
Fakultní Nemocnice Ostrava
🇨🇿Ostrava - Poruba, Severomoravsky Kraj, Czechia
Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou
🇫🇷Rennes cedex 9, Bretagne, France
Fondazione PTV - Policlinico Tor Vergata
🇮🇹Roma, Italy
Soon Chun Hyang University Hospital Bucheon
🇰🇷Bucheon-si, Gyeonggi-do, Korea, Republic of
Hadassah-Hebrew University Medical Center
🇮🇱Jerusalem, Israel
Meir Medical Center
🇮🇱Kfar Saba, Israel
Policlinico Universitario di Catania
🇮🇹Catania, Italy
Azienda Ospedaliero-Universitaria Policlinico di Modena
🇮🇹Modena, Italy
Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn
🇩🇪Berlin, Germany
Soroka University Medical Center
🇮🇱Beer Sheva, Beersheba, Israel
Tel Aviv Sourasky Medical Center
🇮🇱Tel Aviv, Israel
Azienda Ospedaliera San Gerardo di Monza
🇮🇹Monza, Monza E Brianza, Italy
Università degli studi Federico II di Napoli
🇮🇹Napoli, Italy
Seoul National University Hospital
🇰🇷Seoul, Korea, Republic of
Gachon University Gil Medical Center
🇰🇷Incheon, Gyeonggi-Do, Korea, Republic of
Uniwersyteckie Centrum Kliniczne
🇵🇱Gdansk, Pomorskie, Poland
Korea University Anam Hospital
🇰🇷Seoul, Korea, Republic of
Asan Medical Center
🇰🇷Seoul, Korea, Republic of
10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy
🇵🇱Bydgoszcz, Kujawsko-pomorskie, Poland
Hospital de la Santa Creu i Sant Pau
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Universitario La Princesa
🇪🇸Madrid, Spain
Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego
🇵🇱Lódz, Lodzkie, Poland
Hospital Quirón Madrid
🇪🇸Pozuelo de Alarcón, Madrid, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)
🇨🇭Lausanne, Vaud, Switzerland
Universitätsspital Basel
🇨🇭Basel, Switzerland
Glenfield Hospital
🇬🇧Leicester, England, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, England, United Kingdom
Seoul National University Bundang Hospital
🇰🇷Seongnam-si, Gyeonggi-do, Korea, Republic of
Ruhrlandklinik
🇩🇪Mannheim, Baden-wuerttemberg, Germany
Universität Freiburg, Klinikum, Abt für Pneumologie
🇩🇪Freiburg, Baden-wuerttemberg, Germany
Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH
🇩🇪Giessen, Hessen, Germany
Klinikum Großhadern der Ludwig-Maximilians-Universität München
🇩🇪München, Bayern, Germany
Medizinische Hochschule Hannover
🇩🇪Hanover, Niedersachsen, Germany
Lungenfachklinik Immenhausen
🇩🇪Immenhausen, Hessen, Germany
Fachkrankenhaus Coswig
🇩🇪Coswig, Sachsen, Germany
Emory University Hospital
🇺🇸Atlanta, Georgia, United States
Cleveland Clinic Florida
🇺🇸Weston, Florida, United States
Loyola University Medical Center
🇺🇸Maywood, Illinois, United States
Duke University Medical Center
🇺🇸Durham, North Carolina, United States
North Shore University Hospital
🇺🇸New Hyde Park, New York, United States
University of California Davis Medical Center
🇺🇸Sacramento, California, United States
Northwestern University
🇺🇸Chicago, Illinois, United States
Kentuckiana Pulmonary Associates
🇺🇸Louisville, Kentucky, United States
Yale University School of Medicine
🇺🇸New Haven, Connecticut, United States
University of Louisville
🇺🇸Louisville, Kentucky, United States
David Geffen School of Medicine at University of California, Los Angeles
🇺🇸Los Angeles, California, United States
Stanford University Medical Center
🇺🇸Stanford, California, United States
Mayo Clinic Florida
🇺🇸Jacksonville, Florida, United States
Bay Area Chest Physicians
🇺🇸Clearwater, Florida, United States
University of Iowa Hospitals and Clinics
🇺🇸Iowa City, Iowa, United States
Mount Sinai School of Medicine
🇺🇸New York, New York, United States
Royal Prince Alfred Hospital
🇦🇺Camperdown, New South Wales, Australia
Thomas Jefferson University Hospital
🇺🇸Philadelphia, Pennsylvania, United States
Fakultní nemocnice Plzen
🇨🇿Plzen, Zapadocesky Kraj, Czechia
Centre Hospitalier Universitaire Grenoble Hopital Michalon
🇫🇷Grenoble Cedex 9, Rhone-Alpes, France
Hôpital Bichat-Claude Bernard
🇫🇷Paris, Ile-de-france, France
Centre Hospitalier Universitaire de Nice-Hôpital Pasteur
🇫🇷Nice CEDEX 1, Poitou-charentes, France
Thoraxklinik am Universitätsklinikum Heidelberg
🇩🇪Heidelberg, Baden-wuerttemberg, Germany
Samsung Medical Center
🇰🇷Seoul, Gyeonggi-do, Korea, Republic of
Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)
🇮🇹Palermo, Italy
Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte
🇮🇹Siena, Italy
Birmingham Heartlands Hospital
🇬🇧Birmingham, England, United Kingdom
Inova Fairfax Hospital
🇺🇸Falls Church, Virginia, United States
University of California San Diego
🇺🇸La Jolla, California, United States
Saint James's University Hospital
🇬🇧Leeds, England, United Kingdom
Hospital Clinic de Barcelona
🇪🇸Barcelona, Spain
Papworth Hospital
🇬🇧Cambridge, England, United Kingdom
Royal Devon and Exeter Hospital
🇬🇧Exeter, England, United Kingdom
Aintree University Hospitals NHS Foundation Trust
🇬🇧Liverpool, England, United Kingdom
Churchill Hospital
🇬🇧Oxford, England, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, Scotland, United Kingdom
Glasgow Royal Infirmary
🇬🇧Glasgow, Scotland, United Kingdom
Royal Brompton Hospital
🇬🇧London, England, United Kingdom
Castle Hill Hospital
🇬🇧Cottingham, England, United Kingdom