TerminatedNCT01769196RAINIERUpdated May 30, 2017Results posted

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

A Phase 2 interventional study of Simtuzumab and Simtuzumab placebo in Idiopathic Pulmonary Fibrosis, sponsored by Gilead Sciences. Terminated at 175 sites in 14 countries. Open to participants aged 45 Years to 85 Years. Per ClinicalTrials.gov, last updated 2017-05-30.

Sponsored by Gilead Sciences · Phase 2, Interventional, and Treatment

Why this study was terminated

The Study was terminated due to lack of efficacy.

Phase: Phase 2
Study type: Interventional
Enrollment: 544
Allocation: Randomized
Ages: 45 Years to 85 Years
Sex: All

Study 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 studied

Idiopathic Pulmonary Fibrosis

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Keywords

Idiopathic
Pulmonary
Fibrosis
IPF

In context

Pulmonary Fibrosis

680 studies on the registry are indexed under Pulmonary Fibrosis; 119 are open to participants now.

This study's enrollment of 544 is above the median of 50 across 419 interventional studies indexed under Pulmonary Fibrosis.

Browse Pulmonary Fibrosis studies →

Lead sponsor

Gilead Sciences is the lead sponsor of 680 studies on the registry; 24 are open to participants now.

Of its 259 completed or terminated interventional studies of FDA-regulated products, 249 (96%) have results posted.

Counted across the registry records on this site, refreshed daily.

Who can participate

Ages eligible: 45 Years to 85 Years
Sexes eligible: All
Accepts healthy volunteers: No

Eligibility criteria

Key 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

Key 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.

Note: Other protocol defined Inclusion/Exclusion criteria may apply.

Study design

Phase: Phase 2
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel assignment
Masking: Double (Participant, Investigator)
Enrollment: 544 participants (actual)

Study arms

Experimental
Simtuzumab
Participants will receive simtuzumab for up to 254 weeks.
Drug: Simtuzumab
Placebo comparator
Simtuzumab Placebo
Participants will receive simtuzumab placebo for up to 254 weeks.
Drug: Simtuzumab placebo

Interventions

DrugSimtuzumab
125 mg/mL single-dose vials administered subcutaneously once a week
Also known as: GS-6624
DrugSimtuzumab placebo
Simtuzumab placebo single-dose vials administered subcutaneously once a week

What researchers measure

Primary outcomes

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.
Time frame: Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 50th Percentile
Time frame: Up to 148 weeks
PFS Among the Participants With sLOXL2 ≥ 75th Percentile
Time frame: Up to 148 weeks

Secondary outcomes

Overall Survival (OS)
Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
Time frame: Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Time frame: Up to 151 weeks
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Time frame: Up to 151 weeks
Relative Change From Baseline in FVC % Predicted
* 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.
Time frame: Weeks 54, 106, and 130
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Time frame: Up to 148 weeks
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Time frame: Up to 148 weeks
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Time frame: Up to 148 weeks
Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
* 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.
Time frame: Weeks 58, 106, and 130
Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
* 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.
Time frame: Week 58, 106, and 130

Results

Posted Apr 13, 2017

Participant flow

Participants were enrolled at study sites in North America, Europe, and Asia Pacific. The first participant was screened on 31 January 2013. The last study visit occurred on 23 February 2016.

Participant flow — Overall Study
Milestone	Simtuzumab	Simtuzumab Placebo
Started	272	272
Completed	0	0
Not completed	272	272
Withdrew: Adverse event	24	20
Withdrew: Death	21	26
Withdrew: Investigator discretion	7	3
Withdrew: Lack of efficacy	3	2
Withdrew: Progressive disease	11	6
Withdrew: Protocol defined criteria for withdrawal	9	11
Withdrew: Protocol violation	0	3
Withdrew: Study terminated by sponsor	160	161
Withdrew: Participant never dosed with study drug	1	0
Withdrew: Withdrew consent	36	40

Outcome measures

PrimaryProgression 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.

Time frame:: Up to 148 weeks
Reported as:: Median · months

Progression Free Survival
months	Simtuzumab	Simtuzumab Placebo
Progression Free Survival	12.6 (11.3 to 14.4)	15.4 (12.6 to 19.1)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.329 · Hazard ratio (hr): 1.13 · 95% CI 0.88 to 1.45Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.

PrimaryPFS Among the Participants With sLOXL2 ≥ 50th Percentile

Time frame:: Up to 148 weeks
Reported as:: Median · months

PFS Among the Participants With sLOXL2 ≥ 50th Percentile
months	Simtuzumab	Simtuzumab Placebo
PFS Among the Participants With sLOXL2 ≥ 50th Percentile	11.7 (9.9 to 15.9)	14.3 (10.4 to 19.1)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.851 · Hazard ratio (hr): 1.03 · 95% CI 0.74 to 1.43Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.

PrimaryPFS Among the Participants With sLOXL2 ≥ 75th Percentile

Time frame:: Up to 148 weeks
Reported as:: Median · months

PFS Among the Participants With sLOXL2 ≥ 75th Percentile
months	Simtuzumab	Simtuzumab Placebo
PFS Among the Participants With sLOXL2 ≥ 75th Percentile	11.6 (9.0 to 15.0)	16.9 (7.7 to 21.7)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.475 · Hazard ratio (hr): 1.20 · 95% CI 0.72 to 2.00Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.

SecondaryOverall Survival (OS)

Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.

Time frame:: Up to 151 weeks
Reported as:: Median · months

Overall Survival (OS)
months	Simtuzumab	Simtuzumab Placebo
Overall Survival (OS)	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.602 · Hazard ratio (hr): 1.20 · 95% CI 0.61 to 2.37Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted, sLOXL2 level categories, and concomitant pirfenidone/nintedanib use at time of screening.

SecondaryOverall Survival Among the Participants With sLOXL2 ≥ 50th Percentile

Time frame:: Up to 151 weeks
Reported as:: Median · months

Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
months	Simtuzumab	Simtuzumab Placebo
Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile	NA (NA to NA)	NA (NA to NA)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.988 · Hazard ratio (hr): 0.99 · 95% CI 0.43 to 2.28Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.

SecondaryOverall Survival Among the Participants With sLOXL2 ≥ 75th Percentile

Time frame:: Up to 151 weeks
Reported as:: Median · months

Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
months	Simtuzumab	Simtuzumab Placebo
Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile	NA (19.2 to NA)	NA (NA to NA)

Statistical analysis

Simtuzumab vs Simtuzumab Placebo · Log Rank · p = 0.925 · Hazard ratio (hr): 0.95 · 95% CI 0.30 to 2.99Hazard ratio was estimated from Cox regression model adjusted for treatment and stratified for screening post-bronchodilator FVC % predicted and concomitant pirfenidone/nintedanib use at time of screening.

SecondaryRelative Change From Baseline in FVC % Predicted

* 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.

Time frame:: Weeks 54, 106, and 130
Reported as:: Least squares mean · Percent change in FVC % predicted

Relative Change From Baseline in FVC % Predicted
Percent change in FVC % predicted	Simtuzumab	Simtuzumab Placebo
Week 54	-9.20 ± 0.643	-8.88 ± 0.658
Week 106	-13.70 ± 0.883	-12.16 ± 0.908
Week 130	-18.09 ± 1.712	-11.83 ± 1.600

SecondaryDefinite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations

Time frame:: Up to 148 weeks
Reported as:: Count of participants · Participants

Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Participants	Simtuzumab	Simtuzumab Placebo
Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations	5	5

SecondaryNumber of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations

Time frame:: Up to 148 weeks
Reported as:: Count of participants · Participants

Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Participants	Simtuzumab	Simtuzumab Placebo
Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations	99	84

SecondaryNumber of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death

Time frame:: Up to 148 weeks
Reported as:: Count of participants · Participants

Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Participants	Simtuzumab	Simtuzumab Placebo
Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death	17	13

SecondaryAbsolute Change From Baseline in 6 Minute Walk Distance (6MWD)

* 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.

Time frame:: Weeks 58, 106, and 130
Reported as:: Least squares mean · Meters

Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Meters	Simtuzumab	Simtuzumab Placebo
Week 58	-33.76 ± 6.617	-14.70 ± 6.596
Week 106	-37.43 ± 9.710	-24.30 ± 10.318
Week 130	-71.20 ± 19.140	-31.65 ± 18.458

SecondaryAbsolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score

* 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.

Time frame:: Week 58, 106, and 130
Reported as:: Least squares mean · units on a scale

Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score
units on a scale	Simtuzumab	Simtuzumab Placebo
Week 58	6.07 ± 1.015	3.62 ± 1.010
Week 106	10.34 ± 1.425	6.54 ± 1.559
Week 130	18.10 ± 2.424	1.08 ± 2.473

Adverse events

Collected over 30 days post last study treatment (up to 148 weeks). Non-serious events are listed at a 5% frequency threshold.

Adverse event summary by group
Group	Deaths	Serious	Other
Simtuzumab	31/271 (11.4%)	101/271 (37.3%)	237/271 (87.5%)
Simtuzumab Placebo	32/272 (11.8%)	97/272 (35.7%)	246/272 (90.4%)

Most frequent serious events

Showing 10 of 151

Most frequent serious events
Event	Simtuzumab	Simtuzumab Placebo
Idiopathic pulmonary fibrosisRespiratory, thoracic and mediastinal disorders	31/271	35/272
PneumoniaInfections and infestations	16/271	18/272
DyspnoeaRespiratory, thoracic and mediastinal disorders	10/271	7/272
Atrial fibrillationCardiac disorders	6/271	1/272
Acute respiratory failureRespiratory, thoracic and mediastinal disorders	6/271	1/272
Respiratory failureRespiratory, thoracic and mediastinal disorders	5/271	4/272
Acute myocardial infarctionCardiac disorders	3/271	5/272
Cholecystitis acuteHepatobiliary disorders	4/271	1/272
Lower respiratory tract infectionInfections and infestations	0/271	4/272
Urinary tract infectionInfections and infestations	3/271	0/272

Most frequent other events

Showing 10 of 37

Most frequent other events
Event	Simtuzumab	Simtuzumab Placebo
CoughRespiratory, thoracic and mediastinal disorders	102/271	93/272
DyspnoeaRespiratory, thoracic and mediastinal disorders	98/271	73/272
Upper respiratory tract infectionInfections and infestations	57/271	57/272
FatigueGeneral disorders	49/271	48/272
DiarrhoeaGastrointestinal disorders	44/271	47/272
NasopharyngitisInfections and infestations	36/271	43/272
BronchitisInfections and infestations	32/271	39/272
ArthralgiaMusculoskeletal and connective tissue disorders	35/271	22/272
NauseaGastrointestinal disorders	33/271	35/272
HeadacheNervous system disorders	32/271	35/272

Baseline characteristics

Intent-to-Treat (ITT) Analysis Set included all participants who were randomized into the study, and were analyzed according to treatment randomized.

Age, Continuous
Age, Continuous(years)	Simtuzumab	Simtuzumab Placebo	Total
Mean	67.7 ± 7.60	68.5 ± 7.07	68.1 ± 7.34

Sex: Female, Male
Sex: Female, Male(Participants)	Simtuzumab	Simtuzumab Placebo	Total
Female	45	47	92
Male	227	225	452

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Simtuzumab	Simtuzumab Placebo	Total
Asian	35	36	71
Black	3	3	6
White	231	229	460
Other	3	4	7

Race/Ethnicity, Customized
Race/Ethnicity, Customized(Participants)	Simtuzumab	Simtuzumab Placebo	Total
Hispanic or Latino	5	7	12
Not Hispanic or Latino	267	264	531
Not Permitted	0	1	1

Region of Enrollment
Region of Enrollment(Participants)	Simtuzumab	Simtuzumab Placebo	Total
United States	102	106	208
Korea, Republic of	34	35	69
Spain	11	13	24
Canada	10	14	24
Czech Republic	6	6	12
Belgium	10	4	14
United Kingdom	12	21	33
Poland	15	13	28
Italy	8	6	14
Israel	7	5	12
Australia	11	18	29
France	24	12	36
Germany	22	18	40
Switzerland	0	1	1

Forced vital capacity (FVC) Percent Predicted
Forced vital capacity (FVC) Percent Predicted(FVC % predicted)	Simtuzumab	Simtuzumab Placebo	Total
Mean	61.4 ± 12.17	62.3 ± 12.22	61.8 ± 12.19

FVC % Predicted Category
FVC % Predicted Category(Participants)	Simtuzumab	Simtuzumab Placebo	Total
Mild	37	46	83
Moderate	152	150	302
Severe	83	76	159

Baseline Serum LOXL2
Baseline Serum LOXL2(pg/mL)	Simtuzumab	Simtuzumab Placebo	Total
Mean	89.8 ± 70.06	86.7 ± 51.99	88.2 ± 61.48

Study locations

175 sites

University of Alabama at Birmingham
Birmingham, Alabama 35294, United States
Arizona Pulmonary Specialists, Ltd.
Phoenix, Arizona 85012, United States
Saint Joseph's Hospital and Medical Center
Phoenix, Arizona 85103, United States
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona 85258, United States
Mayo Clinic Arizona
Scottsdale, Arizona 85259, United States
The University of Arizona
Tucson, Arizona 85724, United States
University of California San Diego
La Jolla, California 92093, United States
David Geffen School of Medicine at University of California, Los Angeles
Los Angeles, California 90024, United States
University of California Davis Medical Center
Sacramento, California 95817, United States
University of California San Francisco
San Francisco, California 94143, United States
Sansum Clinic
Santa Barbara, California 93105, United States
Stanford University Medical Center
Stanford, California 94305, United States
National Jewish Health
Denver, Colorado 80206, United States
Yale University School of Medicine
New Haven, Connecticut 06150, United States
Bay Area Chest Physicians
Clearwater, Florida 33756, United States
University of Florida
Jacksonville, Florida 32209, United States
Mayo Clinic Florida
Jacksonville, Florida 32224, United States
University of Miami
Miami, Florida 33136, United States
Sarasota Memorial Hospital
Sarasota, Florida 34239, United States
Tampa General Hospital
Tampa, Florida 33606, United States
Cleveland Clinic Florida
Weston, Florida 33331, United States
Emory University Hospital
Atlanta, Georgia 30322, United States
Southeastern Lung Care
Decatur, Georgia 30033, United States
Northwestern University
Chicago, Illinois 60611, United States
Rush University Medical Center
Chicago, Illinois 60612, United States
University of Chicago
Chicago, Illinois 60637, United States
Loyola University Medical Center
Maywood, Illinois 60153, United States
Loess Hills Clinical Research Center
Council Bluffs, Iowa 51503, United States
University of Iowa Hospitals and Clinics
Iowa City, Iowa 52242, United States
Kentuckiana Pulmonary Associates
Louisville, Kentucky 40202, United States
University of Louisville
Louisville, Kentucky 40202, United States
Tulane University School of Medicine
New Orleans, Louisiana 70112, United States
University of Maryland
Baltimore, Maryland 21201, United States
Tufts University School of Medicine
Boston, Massachusetts 02111, United States
Brigham and Women's Hospital
Boston, Massachusetts 02120, United States
Beth Israel Deaconess Medical Center
Boston, Massachusetts 02215, United States
Massachusetts General Hospital
Boston, Massachusetts, United States
Henry Ford Hospital
Detroit, Michigan 48124, United States
University of Minnesota Medical Center
Minneapolis, Minnesota 55455, United States
Mayo Clinic
Rochester, Minnesota 55905, United States
CardioPulmonary Associates
Chesterfield, Missouri 63017, United States
Saint Luke's Midwest Pulmonary Consultants
Kansas City, Missouri 64111, United States
Washington University School of Medicine
Saint Louis, Missouri 63110, United States
Dartmouth Hitchcock Medical Center
Lebanon, New Hampshire 55905, United States
Robert Wood Johnson Medical School
New Brunswick, New Jersey 08903-0019, United States
Pulmonary and Allergy Associates, PA
Summit, New Jersey 07901, United States
Albany Medical College
Albany, New York 12208, United States
Jamaica Hospital Medical Center
Jamaica, New York 11418, United States
North Shore University Hospital
New Hyde Park, New York 11040, United States
Mount Sinai School of Medicine
New York, New York 10029, United States
Columbia University
New York, New York 10032, United States
Weill Cornell Medical College
New York, New York 10065, United States
University of Rochester
Rochester, New York 14620, United States
Duke University Medical Center
Durham, North Carolina 27710, United States
University of Cincinnati Medical Center
Cincinnati, Ohio 45267, United States
University of Cincinnati
Cincinnati, Ohio 45267, United States
Cleveland Clinic
Cleveland, Ohio 44195, United States
Ohio State University
Columbus, Ohio 43221, United States
Miami Valley Hospital
Dayton, Ohio 45409, United States
The Oregon Clinic, PC
Portland, Oregon 97220, United States
University of Pennsylvania
Philadelphia, Pennsylvania 19104, United States
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107, United States
Temple University Hospital, Temple Lung Center
Philadelphia, Pennsylvania 19140, United States
University of Pittsburgh Presbyterian - Montefiore
Pittsburgh, Pennsylvania 15213, United States
Medical University of South Carolina
Charleston, South Carolina 29425, United States
Vanderbilt University Medical Center
Nashville, Tennessee 37232, United States
Baylor College of Medicine
Houston, Texas 77030, United States
University of Utah
Salt Lake City, Utah 84108, United States
Inova Fairfax Hospital
Falls Church, Virginia 22042, United States
Providence Everett Medical Center
Everett, Washington 98201, United States
University of Washington
Seattle, Washington 98195, United States
Froedtert Hospital and Medical College of Wisconsin
Milwaukee, Wisconsin 53226, United States
Royal Prince Alfred Hospital
Camperdown, New South Wales 2050, Australia
Concord Repatriation General Hospital
Concord, New South Wales 2139, Australia
Saint Vincents Hospital
Darlinghurst, New South Wales 2010, Australia
Mater Adult Hospital
Brisbane, Queensland 4000, Australia
Prince Charles Hospital
Chermside, Queensland 4032, Australia
Royal Brisbane and Women's Hospital
Herston, Queensland 4029, Australia
Royal Adelaide Hospital
Adelaide, South Australia 5000, Australia
The Alfred Hospital
Melbourne, Victoria 3004, Australia
Sir Charles Gairdner Hospital
Nedlands, Western Australia 6009, Australia
Royal Perth Hospital
Perth, Western Australia 6000, Australia
ULB Erasme
Anderlecht, Brussels 1070, Belgium
Universitair Ziekenhuis Leuven
Leuven, Flemish Brabant 3000, Belgium
Cliniques Universitaires UCL de Mont-Godinne
Yvoir, Namur 5530, Belgium
Kelowna Respiratory and Allergy Clinic
Kelowna, British Columbia V1Y1E4, Canada
Vancouver General Hospital
Vancouver, British Columbia V5Z 1M9, Canada
University of British Columbia
Vancouver, British Columbia V6Z 1Y6, Canada
Saint Joseph's Healthcare
Hamilton, Ontario L8N 4A6, Canada
University Health Network
Toronto, Ontario M5G2C4, Canada
Centre Hospitalier de L'Université de Montréal Hôtel-Dieu
Montreal, Quebec H2W 1T8, Canada
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Quebec City, Quebec G1V4G5, Canada
Fakultní nemocnice Brno
Brno, Jihormoravsky Kraj 625 00, Czechia
Nemocnice Jihlava
Jihlava, Jihormoravsky Kraj 689 32, Czechia
Krajská nemocnice Liberec a.s.
Liberec, Severocesky Kraj 460 63, Czechia
Masarykova nemocnice v Ústí nad Labem o.z.
Ústí nad Labem, Severocesky Kraj 401 13, Czechia
Fakultní Nemocnice Ostrava
Ostrava - Poruba, Severomoravsky Kraj 708 52, Czechia
Fakultní nemocnice Plzen
Plzen, Zapadocesky Kraj 305 99, Czechia
Thomayerova nemocnice
Prague 4 - Krc, 140 59, Czechia
Hôpitaux Universitaires de Strasbourg
Strasbourg, Alsace 67091, France

Showing the first 100 of 175 sites across 14 countries.

References and documents

Publications

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. PubMed 27939076 ↗
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.

Updates

Tracking since Sep 25, 2026

No changes since tracking began. The registry record was last updated on May 30, 2017, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗

Registry details

Key details

Study ID: NCT01769196
Lead sponsor: Gilead Sciences
Responsible party: Sponsor
First posted: Jan 16, 2013
Start date: Jan 31, 2013
Primary completion: Feb 23, 2016
Completion: Feb 23, 2016
Results posted: Apr 13, 2017
Last update: May 30, 2017

Study contacts

Gilead Study Director

study director · Gilead Sciences

Oversight

Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No

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This study is terminated, as verified in Apr 2017. You cannot join it, but the record below documents what was studied.

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Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

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