A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
First received: January 14, 2013
Last updated: November 24, 2015
Last verified: November 2015
This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.

Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab (GS-6624)
Drug: Placebo to match simtuzumab
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
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)

Resource links provided by NLM:

Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Progression free survival [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    Progression free survival (PFS) is defined as all-cause mortality or a categorical decrease in forced vital capacity (FVC) % predicted (≥ 10% relative decrease in FVC and ≥ 5% absolute decrease in FVC).

  • PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.

Secondary Outcome Measures:
  • All-cause mortality [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    From the date of randomization to the date of death from any cause, assessed up to 254 weeks.

  • All-cause mortality among participants with "high" sLOXL2 at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.

Estimated Enrollment: 500
Study Start Date: January 2013
Estimated Study Completion Date: January 2021
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab (GS-6624)
Participants will receive simtuzumab (GS-6624) for up to 254 weeks.
Drug: Simtuzumab (GS-6624)
Simtuzumab (GS-6624) 125 mg/mL single-dose vials administered subcutaneously weekly
Other Name: GS-6624
Placebo Comparator: Placebo to match simtuzumab
Participants will receive placebo to match simtuzumab for up to 254 weeks.
Drug: Placebo to match simtuzumab
Placebo to match simtuzumab single-dose vials administered subcutaneously weekly


Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No

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

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.
  Contacts and Locations
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Please refer to this study by its ClinicalTrials.gov identifier: NCT01769196

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

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01769196     History of Changes
Other Study ID Numbers: GS-US-322-0207, 2012-001571-36
Study First Received: January 14, 2013
Last Updated: November 24, 2015
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:

Additional relevant MeSH terms:
Idiopathic Interstitial Pneumonias
Idiopathic Pulmonary Fibrosis
Pulmonary Fibrosis
Lung Diseases
Lung Diseases, Interstitial
Pathologic Processes
Respiratory Tract Diseases

ClinicalTrials.gov processed this record on November 27, 2015