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

Idiopathic Pulmonary Fibrosis Clinical Trial

— 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)

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01769196
• Other study ID #: GS-US-322-0207
• Secondary ID: 2012-001571-36
• Status: Terminated
• Phase: Phase 2
• First received: January 14, 2013
• Last updated: March 3, 2016
• Start date: January 2013
• Est. completion date: February 2016

Study information

• Verified date: March 2016
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial Summary

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 544
• Est. completion date: February 2016
• Est. primary completion date: February 2016
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 45 Years to 85 Years

Eligibility

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.

Study Design

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

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

Drug:
• Simtuzumab (GS-6624)
Simtuzumab (GS-6624) 125 mg/mL single-dose vials administered subcutaneously weekly
• Placebo to match simtuzumab
Placebo to match simtuzumab single-dose vials administered subcutaneously weekly

Locations

Country	Name	City	State
Australia	Royal Adelaide Hospital	Adelaide	South Australia
Australia	Royal Prince Alfred Hospital	Camperdown	New South Wales
Australia	Prince Charles Hospital	Chermside	Queensland
Australia	Concord Repatriation General Hospital	Concord	New South Wales
Australia	Saint Vincents Hospital	Darlinghurst	New South Wales
Australia	Royal Brisbane and Women's Hospital	Herston	Queensland
Australia	The Alfred Hospital	Melbourne	Victoria
Australia	Sir Charles Gairdner Hospital	Nedlands	Western Australia
Australia	Royal Perth Hospital	Perth	Western Australia
Belgium	ULB Erasme	Anderlecht	Brussels
Belgium	Universitair Ziekenhuis Leuven	Leuven	Flemish Brabant
Belgium	Cliniques Universitaires UCL de Mont-Godinne	Yvoir	Namur
Canada	Saint Joseph's Healthcare	Hamilton	Ontario
Canada	Kelowna Respiratory and Allergy Clinic	Kelowna	British Columbia
Canada	Centre Hospitalier de L'Université de Montréal Hôtel-Dieu	Montreal	Quebec
Canada	Institut Universitaire de Cardiologie et de Pneumologie de Québec	Quebec City	Quebec
Canada	University Health Network	Toronto	Ontario
Canada	University of British Columbia	Vancouver	British Columbia
Canada	University of British Columbia	Vancouver	British Columbia
Czech Republic	Fakultní nemocnice Brno	Brno	Jihormoravsky Kraj
Czech Republic	Nemocnice Jihlava	Jihlava	Jihormoravsky Kraj
Czech Republic	Krajská nemocnice Liberec a.s.	Liberec	Severocesky Kraj
Czech Republic	Fakultní Nemocnice Ostrava	Ostrava - Poruba	Severomoravsky Kraj
Czech Republic	Fakultní nemocnice Plzen	Plzen	Zapadocesky Kraj
Czech Republic	Thomayerova nemocnice	Prague 4 - Krc
Czech Republic	Masarykova nemocnice v Ústí nad Labem o.z.	Ústí nad Labem	Severocesky Kraj
France	Centre Hospitalier Universitaire Hôpital Avicenne	Bobigny Cedex	Ile-de-france
France	Hôpital Louis Pradel	Bron	Rhone-aples
France	Centre Hospitalier Universitaire Grenoble Hopital Michalon	Grenoble Cedex 9	Rhone-Alpes
France	Hôpital Albert Calmette	Lille cedex	Nord Pas-de-calais
France	Centre Hospitalier Universitaire Hôpital Nord	Marseille Cedex 20	Provence Alpes Cote D'azur
France	Hôpital Arnaud de Villeneuve	Montpellier cedex 5	Languedoc-roussillon
France	Centre Hospitalier Universitaire de Nice-Hôpital Pasteur	Nice CEDEX 1	Poitou-charentes
France	Hôpital Bichat-Claude Bernard	Paris	Ile-de-france
France	HEGP	Paris Cedex 15	Ile-de-france
France	Centre Hospitalier Universitaire de Rennes, Hôpital Pontchaillou	Rennes cedex 9	Bretagne
France	Hôpitaux Universitaires de Strasbourg	Strasbourg	Alsace
France	Hôpital Larrey, CHU de Toulouse, Service de Pneumologie	Toulouse cedex 9	Midi-pyrenees
France	Centre Hospitalier Régional et Universitaire - Hôpital Bretonneau	Tours Cedex 9	Centre
Germany	Helios Klinikum Emil von Behring, Lungenklinik Heckeshorn	Berlin
Germany	Fachkrankenhaus Coswig	Coswig	Sachsen
Germany	Universität Freiburg, Klinikum, Abt für Pneumologie	Freiburg	Baden-wuerttemberg
Germany	Philipps-Universität und Universitätsklinikum Gießen und Marburg GmbH	Giessen	Hessen
Germany	Medizinische Hochschule Hannover	Hanover	Niedersachsen
Germany	Thoraxklinik am Universitätsklinikum Heidelberg	Heidelberg	Baden-wuerttemberg
Germany	Lungenfachklinik Immenhausen	Immenhausen	Hessen
Germany	Universitätsklinikum Leipzig	Leipzig	Sachsen
Germany	Ruhrlandklinik	Mannheim	Baden-wuerttemberg
Germany	Klinikum Großhadern der Ludwig-Maximilians-Universität München	München	Bayern
Israel	Soroka University Medical Center	Beer Sheva	Beersheba
Israel	Hadassah-Hebrew University Medical Center	Jerusalem
Israel	Meir Medical Center	Kfar Saba
Israel	Rabin Medical Center	Petach Tikvah
Israel	Chaim Sheba Medical Center	Tel Hashomer	Tel Aviv
Italy	Policlinico Universitario di Catania	Catania
Italy	Ospedale "G.B.Morgagni - L. Pierantoni"	Forlì	Forli-cesena
Italy	San Giuseppe Hospital, Dept. of Internal Medicine	Milano
Italy	Azienda Ospedaliero-Universitaria Policlinico di Modena	Modena
Italy	Azienda Ospedaliera San Gerardo di Monza	Monza	Monza E Brianza
Italy	AORN Monaldi	Napoli
Italy	Istituto Mediterraneo Trapianti e Terapia Alta Specializzazione (ISMETT)	Palermo
Italy	Fondazione PTV - Policlinico Tor Vergata	Roma
Italy	Policlinico Le Scotte	Siena
Korea, Republic of	Soon Chun Hyang University Hospital Bucheon	Bucheon-si	Gyeonggi-do
Korea, Republic of	Gachon University Gil Medical Center	Incheon	Gyeonggi-Do
Korea, Republic of	Seoul National University Bundang Hospital	Seongnam-si	Gyeonggi-do
Korea, Republic of	Asan Medical Center	Seoul
Korea, Republic of	Korea University Anam Hospital	Seoul
Korea, Republic of	Samsung Medical Center	Seoul	Gyeonggi-do
Korea, Republic of	Seoul National University Hospital	Seoul
Poland	10 Wojskowy Szpital Kliniczny z Poliklinika SP ZOZ w Bydgoszczy	Bydgoszcz	Kujawsko-pomorskie
Poland	Uniwersyteckie Centrum Kliniczne	Gdansk	Pomorskie
Poland	Samodzielny Publiczny ZOZ, Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego	Lódz	Lodzkie
Poland	Instytut Gruzlicy i Chorób Pluc	Warszawa	Mazowieckie
Poland	Samodzielny Publiczny Szpital Kliniczny nr 3 w Zabrzu Slaskiego Uniwersytetu Medycznego w Katowicach	Zabrze	Slaskie
Spain	Hospital Clínic i Provincial	Barcelona
Spain	Hospital de la Santa Creu i Sant Pau	Barcelona
Spain	Hospital Universitario Vall d'Hebron	Barcelona
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Central de Asturias	Oviedo	Asturias
Spain	Hospital Quirón Madrid	Pozuelo de Alarcón	Madrid
Spain	Hospital Universitario Virgen del Rocio	Sevilla
Switzerland	Universitätsspital Basel	Basel
Switzerland	Centre Hospitalier Universitaire Vaudois Lausanne (CHUV)	Lausanne	Vaud
Switzerland	Kantonsspital St. Gallen	St. Gallen	Sankt Gallen
United Kingdom	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 Infirmary of Edinburgh	Edinburgh	Scotland
United Kingdom	Royal Devon and Exeter Hospital	Exeter	England
United Kingdom	Glasgow Royal Infirmary	Glasgow	Scotland
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 States	Albany Medical College	Albany	New York
United States	Emory University Hospital	Atlanta	Georgia
United States	University of Maryland	Baltimore	Maryland
United States	University of Alabama at Birmingham	Birmingham	Alabama
United States	Beth Israel Deaconess Medical Center	Boston	Massachusetts
United States	Brigham and Women's Hospital	Boston	Massachusetts
United States	Massachusetts General Hospital	Boston	Massachusetts
United States	Tufts University School of Medicine	Boston	Massachusetts
United States	Medical University of South Carolina	Charleston	South Carolina
United States	CardioPulmonary Associates	Chesterfield	Missouri
United States	Northwestern University	Chicago	Illinois
United States	Rush University Medical Center	Chicago	Illinois
United States	University of Chicago	Chicago	Illinois
United States	University of Cincinnati	Cincinnati	Ohio
United States	Bay Area Chest Physicians	Clearwater	Florida
United States	Cleveland Clinic	Cleveland	Ohio
United States	Ohio State University	Columbus	Ohio
United States	Loess Hills Clinical Research Center	Council Bluffs	Iowa
United States	Miami Valley Hospital	Dayton	Ohio
United States	Southeastern Lung Care	Decatur	Georgia
United States	National Jewish Health	Denver	Colorado
United States	Henry Ford Hospital	Detroit	Michigan
United States	Duke University Medical Center	Durham	North Carolina
United States	Providence Everett Medical Center	Everett	Washington
United States	Inova Fairfax Hospital	Falls Church	Virginia
United States	Baylor College of Medicine	Houston	Texas
United States	University of Iowa Hospitals and Clinics	Iowa City	Iowa
United States	Mayo Clinic Florida	Jacksonville	Florida
United States	University of Florida	Jacksonville	Florida
United States	Jamaica Hospital Medical Center	Jamaica	New York
United States	Saint Luke's Midwest Pulmonary Consultants	Kansas City	Missouri
United States	University of California San Diego	La Jolla	California
United States	Dartmouth Hitchcock Medical Center	Lebanon	New Hampshire
United States	David Geffen School of Medicine at University of California, Los Angeles	Los Angeles	California
United States	Kentuckiana Pulmonary Associates	Louisville	Kentucky
United States	University of Louisville	Louisville	Kentucky
United States	Loyola University Medical Center	Maywood	Illinois
United States	University of Miami	Miami	Florida
United States	Froedtert Hospital and Medical College of Wisconsin	Milwaukee	Wisconsin
United States	University of Minnesota Medical Center	Minneapolis	Minnesota
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	Robert Wood Johnson Medical School	New Brunswick	New Jersey
United States	Yale University School of Medicine	New Haven	Connecticut
United States	North Shore University Hospital	New Hyde Park	New York
United States	Tulane University School of Medicine	New Orleans	Louisiana
United States	Columbia University	New York	New York
United States	Mount Sinai School of Medicine	New York	New York
United States	Weill Cornell Medical College	New York	New York
United States	Temple University Hospital, Temple Lung Center	Philadelphia	Pennsylvania
United States	Thomas Jefferson University Hospital	Philadelphia	Pennsylvania
United States	University of Pennsylvania	Philadelphia	Pennsylvania
United States	Arizona Pulmonary Specialists, Ltd.	Phoenix	Arizona
United States	Saint Joseph's Hospital and Medical Center	Phoenix	Arizona
United States	University of Pittsburgh Presbyterian - Montefiore	Pittsburgh	Pennsylvania
United States	The Oregon Clinic, PC	Portland	Oregon
United States	Highland Hospital	Rochester	New York
United States	Mayo Clinic	Rochester	Minnesota
United States	University of California Davis Medical Center	Sacramento	California
United States	Washington University School of Medicine	Saint Louis	Missouri
United States	University of Utah	Salt Lake City	Utah
United States	University of California San Francisco	San Francisco	California
United States	Sansum Clinic	Santa Barbara	California
United States	Sarasota Memorial Hospital	Sarasota	Florida
United States	Arizona Pulmonary Specialists, Ltd.	Scottsdale	Arizona
United States	Mayo Clinic Arizona	Scottsdale	Arizona
United States	University of Washington	Seattle	Washington
United States	Stanford University Medical Center	Stanford	California
United States	Pulmonary and Allergy Associates, PA	Summit	New Jersey
United States	Tampa General Hospital	Tampa	Florida
United States	The University of Arizona	Tucson	Arizona
United States	Cleveland Clinic Florida	Weston	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Countries where clinical trial is conducted

United States,  Australia,  Belgium,  Canada,  Czech Republic,  France,  Germany,  Israel,  Italy,  Korea, Republic of,  Poland,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival	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).	Up to 254 weeks	No
Primary	PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline	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.	Up to 254 weeks	No
Secondary	All-cause mortality	From the date of randomization to the date of death from any cause, assessed up to 254 weeks.	Up to 254 weeks	No
Secondary	All-cause mortality among participants with "high" sLOXL2 at baseline	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.	Up to 254 weeks	No