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

NCT01769196 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: GS-US-322-02072012-001571-36
• Study Type: interventional
• Target: 544
• Locations: 14 countries
• Sites: 175

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Idiopathic; Pulmonary; Fibrosis; IPF

Outcome Measures

Primary Outcomes (3)

• 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.

  Up to 148 weeks

• 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 Outcomes (9)

• Overall Survival (OS)

  Up to 151 weeks

• 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

• Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations

  Up to 148 weeks

Study Arms (2)

Simtuzumab

EXPERIMENTAL

Participants will receive simtuzumab for up to 254 weeks.

Drug: Simtuzumab

Simtuzumab Placebo

PLACEBO COMPARATOR

Participants will receive simtuzumab placebo for up to 254 weeks.

Drug: Simtuzumab placebo

Interventions

Simtuzumab DRUG

125 mg/mL single-dose vials administered subcutaneously once a week

Also known as: GS-6624

Simtuzumab

Simtuzumab placebo DRUG

Simtuzumab placebo single-dose vials administered subcutaneously once a week

Simtuzumab Placebo

Eligibility Criteria

• Age: 45 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (175)

University of Alabama at Birmingham

Birmingham, Alabama, 35294, United States

Location

Arizona Pulmonary Specialists, Ltd.

Phoenix, Arizona, 85012, United States

Location

Saint Joseph's Hospital and Medical Center

Phoenix, Arizona, 85103, United States

Location

Arizona Pulmonary Specialists, Ltd.

Scottsdale, Arizona, 85258, United States

Location

Mayo Clinic Arizona

Scottsdale, Arizona, 85259, United States

Location

The University of Arizona

Tucson, Arizona, 85724, United States

Location

University of California San Diego

La Jolla, California, 92093, United States

Location

David Geffen School of Medicine at University of California, Los Angeles

Los Angeles, California, 90024, United States

Location

University of California Davis Medical Center

Sacramento, California, 95817, United States

Location

University of California San Francisco

San Francisco, California, 94143, United States

Location

Sansum Clinic

Santa Barbara, California, 93105, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

National Jewish Health

Denver, Colorado, 80206, United States

Location

Yale University School of Medicine

New Haven, Connecticut, 06150, United States

Location

Bay Area Chest Physicians

Clearwater, Florida, 33756, United States

Location

University of Florida

Jacksonville, Florida, 32209, United States

Location

Mayo Clinic Florida

Jacksonville, Florida, 32224, United States

Location

University of Miami

Miami, Florida, 33136, United States

Location

Sarasota Memorial Hospital

Sarasota, Florida, 34239, United States

Location

Tampa General Hospital

Tampa, Florida, 33606, United States

Location

Cleveland Clinic Florida

Weston, Florida, 33331, United States

Location

Emory University Hospital

Atlanta, Georgia, 30322, United States

Location

Southeastern Lung Care

Decatur, Georgia, 30033, United States

Location

Northwestern University

Chicago, Illinois, 60611, United States

Location

Rush University Medical Center

Chicago, Illinois, 60612, United States

Location

University of Chicago

Chicago, Illinois, 60637, United States

Location

Loyola University Medical Center

Maywood, Illinois, 60153, United States

Location

Loess Hills Clinical Research Center

Council Bluffs, Iowa, 51503, United States

Location

University of Iowa Hospitals and Clinics

Iowa City, Iowa, 52242, United States

Location

Kentuckiana Pulmonary Associates

Louisville, Kentucky, 40202, United States

Location

University of Louisville

Louisville, Kentucky, 40202, United States

Location

Tulane University School of Medicine

New Orleans, Louisiana, 70112, United States

Location

University of Maryland

Baltimore, Maryland, 21201, United States

Location

Tufts University School of Medicine

Boston, Massachusetts, 02111, United States

Location

Brigham and Women's Hospital

Boston, Massachusetts, 02120, United States

Location

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, United States

Location

Henry Ford Hospital

Detroit, Michigan, 48124, United States

Location

University of Minnesota Medical Center

Minneapolis, Minnesota, 55455, United States

Location

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

CardioPulmonary Associates

Chesterfield, Missouri, 63017, United States

Location

Saint Luke's Midwest Pulmonary Consultants

Kansas City, Missouri, 64111, United States

Location

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 55905, United States

Location

Robert Wood Johnson Medical School

New Brunswick, New Jersey, 08903-0019, United States

Location

Pulmonary and Allergy Associates, PA

Summit, New Jersey, 07901, United States

Location

Albany Medical College

Albany, New York, 12208, United States

Location

Jamaica Hospital Medical Center

Jamaica, New York, 11418, United States

Location

North Shore University Hospital

New Hyde Park, New York, 11040, United States

Location

Mount Sinai School of Medicine

New York, New York, 10029, United States

Location

Columbia University

New York, New York, 10032, United States

Location

Weill Cornell Medical College

New York, New York, 10065, United States

Location

University of Rochester

Rochester, New York, 14620, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45267, United States

Location

University of Cincinnati

Cincinnati, Ohio, 45267, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

Ohio State University

Columbus, Ohio, 43221, United States

Location

Miami Valley Hospital

Dayton, Ohio, 45409, United States

Location

The Oregon Clinic, PC

Portland, Oregon, 97220, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Thomas Jefferson University Hospital

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital, Temple Lung Center

Philadelphia, Pennsylvania, 19140, United States

Location

University of Pittsburgh Presbyterian - Montefiore

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

Baylor College of Medicine

Houston, Texas, 77030, United States

Location

University of Utah

Salt Lake City, Utah, 84108, United States

Location

Inova Fairfax Hospital

Falls Church, Virginia, 22042, United States

Location

Providence Everett Medical Center

Everett, Washington, 98201, United States

Location

University of Washington

Seattle, Washington, 98195, United States

Location

Froedtert Hospital and Medical College of Wisconsin

Milwaukee, Wisconsin, 53226, United States

Location

Royal Prince Alfred Hospital

Camperdown, New South Wales, 2050, Australia

Location

Concord Repatriation General Hospital

Concord, New South Wales, 2139, Australia

Location

Saint Vincents Hospital

Darlinghurst, New South Wales, 2010, Australia

Location

Mater Adult Hospital

Brisbane, Queensland, 4000, Australia

Location

Prince Charles Hospital

Chermside, Queensland, 4032, Australia

Location

Royal Brisbane and Women's Hospital

Herston, Queensland, 4029, Australia

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

The Alfred Hospital

Melbourne, Victoria, 3004, Australia

Location

Sir Charles Gairdner Hospital

Nedlands, Western Australia, 6009, Australia

Location

Royal Perth Hospital

Perth, Western Australia, 6000, Australia

Location

ULB Erasme

Anderlecht, Brussels Capital, 1070, Belgium

Location

Universitair Ziekenhuis Leuven

Leuven, Flemish Brabant, 3000, Belgium

Location

Cliniques Universitaires UCL de Mont-Godinne

Yvoir, Namur, 5530, Belgium

Location

Kelowna Respiratory and Allergy Clinic

Kelowna, British Columbia, V1Y1E4, Canada

Location

Vancouver General Hospital

Vancouver, British Columbia, V5Z 1M9, Canada

Location

University of British Columbia

Vancouver, British Columbia, V6Z 1Y6, Canada

Location

Saint Joseph's Healthcare

Hamilton, Ontario, L8N 4A6, Canada

Location

University Health Network

Toronto, Ontario, M5G2C4, Canada

Location

Centre Hospitalier de L'Université de Montréal Hôtel-Dieu

Montreal, Quebec, H2W 1T8, Canada

Location

Institut Universitaire de Cardiologie et de Pneumologie de Québec

Québec, Quebec, G1V4G5, Canada

Location

Fakultní nemocnice Brno

Brno, Jihormoravsky Kraj, 625 00, Czechia

Location

Nemocnice Jihlava

Jihlava, Jihormoravsky Kraj, 689 32, Czechia

Location

Krajská nemocnice Liberec a.s.

Liberec, Severocesky Kraj, 460 63, Czechia

Location

Masarykova nemocnice v Ústí nad Labem o.z.

Ústí nad Labem, Severocesky Kraj, 401 13, Czechia

Location

Fakultní Nemocnice Ostrava

Ostrava - Poruba, Severomoravsky Kraj, 708 52, Czechia

Location

Fakultní nemocnice Plzen

Pilsen, Zapadocesky Kraj, 305 99, Czechia

Location

Thomayerova nemocnice

Prague 4 - Krc, 140 59, Czechia

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, Alsace, 67091, France

Location

Centre Hospitalier Universitaire Grenoble Hopital Michalon

Grenoble, Auvergne-Rhône-Alpes, 38043, France

Location

Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou

Rennes, Brittany Region, 35033, France

Location

Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau

Tours, Centre-Val de Loire, 37044, France

Location

Hôpital Albert Calmette

Lille, Hauts-de-France, 59037, France

Location

Hôpital Arnaud de Villeneuve

Montpellier, Languedoc-roussillon, 34295, France

Location

Hôpital Larrey, CHU de Toulouse, Service de Pneumologie

Toulouse, Midi-pyrenees, 31059, France

Location

Centre Hospitalier Universitaire de Nice-Hôpital Pasteur

Nice, Poitou-charentes, 06002, France

Location

Centre Hospitalier Universitaire Hôpital Nord

Marseille, Provence-Alpes-Côte d'Azur Region, 13015, France

Location

Hôpital Louis Pradel

Bron, Rhone-aples, 69677, France

Location

Centre Hospitalier Universitaire Hôpital Avicenne

Bobigny, Île-de-France Region, 93009, France

Location

Hôpital Bichat-Claude Bernard

Paris, Île-de-France Region, 75018, France

Location

HEGP

Paris, Île-de-France Region, 75908, France

Location

Universität Freiburg, Klinikum, Abt für Pneumologie

Freiburg im Breisgau, Baden-Wurttemberg, 79106, Germany

Location

Thoraxklinik am Universitätsklinikum Heidelberg

Heidelberg, Baden-Wurttemberg, 69126, Germany

Location

Ruhrlandklinik

Mannheim, Baden-Wurttemberg, 68165, Germany

Location

Klinikum Großhadern der Ludwig-Maximilians-Universität München

München, Bavaria, 81377, Germany

Location

Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH

Giessen, Hesse, 35392, Germany

Location

Lungenfachklinik Immenhausen

Immenhausen, Hesse, 34376, Germany

Location

Medizinische Hochschule Hannover

Hanover, Lower Saxony, 30625, Germany

Location

Fachkrankenhaus Coswig

Coswig, Saxony, 01640, Germany

Location

Universitätsklinikum Leipzig

Leipzig, Saxony, 04103, Germany

Location

Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn

Berlin, 14165, Germany

Location

Soroka University Medical Center

Beersheba, Beersheba, 84100, Israel

Location

Chaim Sheba Medical Center

Tel Litwinsky, Tel Aviv, 52621, Israel

Location

Hadassah-Hebrew University Medical Center

Jerusalem, 91120, Israel

Location

Meir Medical Center

Kfar Saba, 44281, Israel

Location

Rabin Medical Center

Petach Tikvah, 49100, Israel

Location

Tel Aviv Sourasky Medical Center

Tel Aviv, 64239, Israel

Location

Ospedale "G.B.Morgagni - L. Pierantoni"

Forlì, Forli-cesena, 47100, Italy

Location

Azienda Ospedaliera San Gerardo di Monza

Monza, Monza E Brianza, 20052, Italy

Location

Policlinico Universitario di Catania

Catania, 95123, Italy

Location

San Giuseppe Hospital, Dept. of Internal Medicine

Milan, 20132, Italy

Location

Azienda Ospedaliero-Universitaria Policlinico di Modena

Modena, 41100, Italy

Location

Università degli studi Federico II di Napoli

Napoli, 80131, Italy

Location

Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)

Palermo, 90127, Italy

Location

Fondazione PTV - Policlinico Tor Vergata

Roma, 00133, Italy

Location

Azienda Ospedaliera Universitaria Senese Policlinico Le Scotte

Siena, 53100, Italy

Location

10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy

Bydgoszcz, Kuyavian-Pomeranian Voivodeship, 85-681, Poland

Location

Instytut Gruzlicy i Chorób Pluc

Warsaw, Masovian Voivodeship, 01-138, Poland

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, 80-952, Poland

Location

Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach

Zabrze, Silesian Voivodeship, 41-803, Poland

Location

Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego

Lódz, Łódź Voivodeship, 90-153, Poland

Location

Soon Chun Hyang University Hospital Bucheon

Bucheon-si, Gyeonggi-do, 420-767, South Korea

Location

Gachon University Gil Medical Center

Incheon, Gyeonggi-do, 405-760, South Korea

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggi-do, 463-707, South Korea

Location

Samsung Medical Center

Seoul, Gyeonggi-do, 135-710, South Korea

Location

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Korea University Anam Hospital

Seoul, 136-705, South Korea

Location

Asan Medical Center

Seoul, 138-736, South Korea

Location

Hospital Quirón Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario Central de Asturias

Oviedo, Principality of Asturias, 33011, Spain

Location

Hospital de la Santa Creu i Sant Pau

Barcelona, 08025, Spain

Location

Hospital Universitario Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Clinic de Barcelona

Barcelona, 08036, Spain

Location

Hospital Universitario La Princesa

Madrid, 28006, Spain

Location

Hospital Universitario Virgen del Rocio

Seville, 41013, Spain

Location

Kantonsspital St. Gallen

Sankt Gallen, Canton of St. Gallen, 9007, Switzerland

Location

Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)

Lausanne, Canton of Vaud, CH 1011, Switzerland

Location

Universitätsspital Basel

Basel, 4031, Switzerland

Location

Birmingham Heartlands Hospital

Birmingham, England, B9 5SS, United Kingdom

Location

Southmead Hospital

Bristol, England, BS10 5NB, United Kingdom

Location

Papworth Hospital

Cambridge, England, CB23 3RE, United Kingdom

Location

Castle Hill Hospital

Cottingham, England, HU16 5JQ, United Kingdom

Location

Royal Devon and Exeter Hospital

Exeter, England, EX2 5DW, United Kingdom

Location

Saint James's University Hospital

Leeds, England, LS9 7TF, United Kingdom

Location

Glenfield Hospital

Leicester, England, LE3 9QP, United Kingdom

Location

Aintree University Hospitals NHS Foundation Trust

Liverpool, England, L9 7AL, United Kingdom

Location

Royal Brompton Hospital

London, England, SW3 6NP, United Kingdom

Location

University Hospital of South Manchester NHS Foundation Trust

Manchester, England, M23 9LT, United Kingdom

Location

Nottingham City Hospital

Nottingham, England, NG5 1PD, United Kingdom

Location

Churchill Hospital

Oxford, England, OX3 7LE, United Kingdom

Location

Northern General Hospital

Sheffield, England, S5 7AU, United Kingdom

Location

Southampton General Hospital

Southampton, England, SO16 6YD, United Kingdom

Location

Royal Infirmary of Edinburgh

Edinburgh, Scotland, EH16 4TJ, United Kingdom

Location

Glasgow Royal Infirmary

Glasgow, Scotland, G11 6NT, United Kingdom

Location

Related Publications (4)

• 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.

  PMID: 27939076 BACKGROUND

• 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.

  RESULT

• 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.

  RESULT

• 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.

  RESULT

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Fibrosis

Interventions

simtuzumab

Condition Hierarchy (Ancestors)

Pulmonary Fibrosis; Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Clinical Trial Disclosures
• Organization: Gilead Sciences

ClinicalTrialDisclosures@gilead.com

Study Officials

• Gilead Study Director

  Gilead Sciences

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 14, 2013
• First Posted: January 16, 2013
• Study Start: January 31, 2013
• Primary Completion: February 23, 2016
• Study Completion: February 23, 2016
• Last Updated: May 30, 2017
• Results First Posted: April 13, 2017

Record last verified: 2017-04

Locations

US (72); AU (10); GB (16); CH (3); BE (3); FR (13); PL (5); KR (7); IT (9); IL (6); CA (7); ES (7); CZ (7); DE (10)