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Trial record 100 of 317 for:    "Pulmonary Fibrosis, Idiopathic"

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

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ClinicalTrials.gov Identifier: NCT01769196
Recruitment Status : Terminated (The Study was terminated due to lack of efficacy.)
First Posted : January 16, 2013
Results First Posted : April 13, 2017
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Double (Participant, Investigator);   Primary Purpose: Treatment
Condition Idiopathic Pulmonary Fibrosis
Interventions Drug: Simtuzumab
Drug: Simtuzumab placebo
Enrollment 544
Recruitment Details 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.
Pre-assignment Details 1250 participants were screened.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description Simtuzumab 125 mg/mL administered subcutaneously once a week Simtuzumab placebo administered subcutaneously once a week
Period Title: Overall Study
Started 272 272
Completed 0 0
Not Completed 272 272
Reason Not Completed
Adverse Event             24             20
Death             21             26
Investigator Discretion             7             3
Lack of Efficacy             3             2
Progressive disease             11             6
Protocol defined criteria for withdrawal             9             11
Protocol Violation             0             3
Study terminated by sponsor             160             161
Participant never dosed with study drug             1             0
Withdrew consent             36             40
Arm/Group Title Simtuzumab Simtuzumab Placebo Total
Hide Arm/Group Description Simtuzumab 125 mg/mL administered subcutaneously once a week Simtuzumab placebo administered subcutaneously once a week Total of all reporting groups
Overall Number of Baseline Participants 272 272 544
Hide Baseline Analysis Population Description
Intent-to-Treat (ITT) Analysis Set included all participants who were randomized into the study, and were analyzed according to treatment randomized.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 272 participants 272 participants 544 participants
67.7  (7.60) 68.5  (7.07) 68.1  (7.34)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 272 participants 544 participants
Female
45
  16.5%
47
  17.3%
92
  16.9%
Male
227
  83.5%
225
  82.7%
452
  83.1%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 272 participants 544 participants
Asian
35
  12.9%
36
  13.2%
71
  13.1%
Black
3
   1.1%
3
   1.1%
6
   1.1%
White
231
  84.9%
229
  84.2%
460
  84.6%
Other
3
   1.1%
4
   1.5%
7
   1.3%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 272 participants 544 participants
Hispanic or Latino
5
   1.8%
7
   2.6%
12
   2.2%
Not Hispanic or Latino
267
  98.2%
264
  97.1%
531
  97.6%
Not Permitted
0
   0.0%
1
   0.4%
1
   0.2%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 272 participants 544 participants
United States
102
  37.5%
106
  39.0%
208
  38.2%
Korea, Republic of
34
  12.5%
35
  12.9%
69
  12.7%
Spain
11
   4.0%
13
   4.8%
24
   4.4%
Canada
10
   3.7%
14
   5.1%
24
   4.4%
Czech Republic
6
   2.2%
6
   2.2%
12
   2.2%
Belgium
10
   3.7%
4
   1.5%
14
   2.6%
United Kingdom
12
   4.4%
21
   7.7%
33
   6.1%
Poland
15
   5.5%
13
   4.8%
28
   5.1%
Italy
8
   2.9%
6
   2.2%
14
   2.6%
Israel
7
   2.6%
5
   1.8%
12
   2.2%
Australia
11
   4.0%
18
   6.6%
29
   5.3%
France
24
   8.8%
12
   4.4%
36
   6.6%
Germany
22
   8.1%
18
   6.6%
40
   7.4%
Switzerland
0
   0.0%
1
   0.4%
1
   0.2%
Forced vital capacity (FVC) Percent Predicted  
Mean (Standard Deviation)
Unit of measure:  FVC % predicted
Number Analyzed 272 participants 272 participants 544 participants
61.4  (12.17) 62.3  (12.22) 61.8  (12.19)
FVC % Predicted Category  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 272 participants 272 participants 544 participants
Mild
37
  13.6%
46
  16.9%
83
  15.3%
Moderate
152
  55.9%
150
  55.1%
302
  55.5%
Severe
83
  30.5%
76
  27.9%
159
  29.2%
Baseline Serum LOXL2  
Mean (Standard Deviation)
Unit of measure:  pg/mL
Number Analyzed 272 participants 272 participants 544 participants
89.8  (70.06) 86.7  (51.99) 88.2  (61.48)
1.Primary Outcome
Title Progression Free Survival
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 272 272
Median (95% Confidence Interval)
Unit of Measure: months
12.6
(11.3 to 14.4)
15.4
(12.6 to 19.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted, sLOXL2 level categories and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.
Statistical Test of Hypothesis P-Value 0.329
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.13
Confidence Interval (2-Sided) 95%
0.88 to 1.45
Estimation Comments Hazard 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.
2.Primary Outcome
Title PFS Among the Participants With sLOXL2 ≥ 50th Percentile
Hide Description [Not Specified]
Time Frame Up to 148 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with serum LOXL2 (sLOXL2) ≥ 50th percentile in peripheral blood were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 137 140
Median (95% Confidence Interval)
Unit of Measure: months
11.7
(9.9 to 15.9)
14.3
(10.4 to 19.1)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 50th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.
Statistical Test of Hypothesis P-Value 0.851
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.03
Confidence Interval (2-Sided) 95%
0.74 to 1.43
Estimation Comments Hazard 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.
3.Primary Outcome
Title PFS Among the Participants With sLOXL2 ≥ 75th Percentile
Hide Description [Not Specified]
Time Frame Up to 148 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 68 71
Median (95% Confidence Interval)
Unit of Measure: months
11.6
(9.0 to 15.0)
16.9
(7.7 to 21.7)
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Superiority
Comments The null hypothesis was that there is no difference in PFS between simtuzumab and simtuzumab placebo in participants with sLOXL2 ≥ 75th percentile. The alternative hypothesis was that there is a difference. These hypotheses were evaluated using stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.
Statistical Test of Hypothesis P-Value 0.475
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.72 to 2.00
Estimation Comments Hazard 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.
4.Secondary Outcome
Title Overall Survival (OS)
Hide Description 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
Hide Outcome Measure Data
Hide Analysis Population Description
ITT Analysis Set
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 272 272
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Not reached due to insufficient number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.602
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 1.20
Confidence Interval (2-Sided) 95%
0.61 to 2.37
Estimation Comments Hazard 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.
5.Secondary Outcome
Title Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile
Hide Description [Not Specified]
Time Frame Up to 151 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with sLOXL2 ≥ 50th percentile in peripheral blood were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 137 140
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(NA to NA)
NA [1] 
(NA to NA)
[1]
NA = Not reached due to insufficient number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.
Statistical Test of Hypothesis P-Value 0.988
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.99
Confidence Interval (2-Sided) 95%
0.43 to 2.28
Estimation Comments Hazard 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.
6.Secondary Outcome
Title Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile
Hide Description [Not Specified]
Time Frame Up to 151 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with sLOXL2 ≥ 75th percentile in peripheral blood were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 68 71
Median (95% Confidence Interval)
Unit of Measure: months
NA [1] 
(19.2 to NA)
NA [1] 
(NA to NA)
[1]
NA = Not reached due to insufficient number of events
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Simtuzumab, Simtuzumab Placebo
Comments [Not Specified]
Type of Statistical Test Other
Comments The difference in OS between the treatment groups was assessed using the stratified log-rank test, adjusted for screening post-bronchodilator FVC % predicted and concomitant use of pirfenidone or nintedanib (P/N) at time of screening.
Statistical Test of Hypothesis P-Value 0.925
Comments [Not Specified]
Method Log Rank
Comments [Not Specified]
Method of Estimation Estimation Parameter Hazard Ratio (HR)
Estimated Value 0.95
Confidence Interval (2-Sided) 95%
0.30 to 2.99
Estimation Comments Hazard 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.
7.Secondary Outcome
Title Relative Change From Baseline in FVC % Predicted
Hide Description
  • 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 272 272
Least Squares Mean (Standard Error)
Unit of Measure: Percent change in FVC % predicted
Week 54 Number Analyzed 124 participants 117 participants
-9.20  (0.643) -8.88  (0.658)
Week 106 Number Analyzed 60 participants 55 participants
-13.70  (0.883) -12.16  (0.908)
Week 130 Number Analyzed 10 participants 12 participants
-18.09  (1.712) -11.83  (1.600)
8.Secondary Outcome
Title Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations
Hide Description [Not Specified]
Time Frame Up to 148 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with adjudicated respiratory hospitalizations were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 99 84
Measure Type: Count of Participants
Unit of Measure: Participants
5
   5.1%
5
   6.0%
9.Secondary Outcome
Title Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations
Hide Description [Not Specified]
Time Frame Up to 148 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in ITT Analysis Set with total hospitalizations were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 181 154
Measure Type: Count of Participants
Unit of Measure: Participants
99
  54.7%
84
  54.5%
10.Secondary Outcome
Title Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death
Hide Description [Not Specified]
Time Frame Up to 148 weeks
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with adjudicated deaths were analyzed.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 19 17
Measure Type: Count of Participants
Unit of Measure: Participants
17
  89.5%
13
  76.5%
11.Secondary Outcome
Title Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)
Hide Description
  • 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 272 272
Least Squares Mean (Standard Error)
Unit of Measure: Meters
Week 58 Number Analyzed 95 participants 98 participants
-33.76  (6.617) -14.70  (6.596)
Week 106 Number Analyzed 44 participants 37 participants
-37.43  (9.710) -24.30  (10.318)
Week 130 Number Analyzed 7 participants 9 participants
-71.20  (19.140) -31.65  (18.458)
12.Secondary Outcome
Title Absolute Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Score
Hide Description
  • 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
Hide Outcome Measure Data
Hide Analysis Population Description
Participants in the ITT Analysis Set with available data were analyzed. Any participant with available outcome data on baseline or post-baseline was included in the MMRM model, thus all 272 participants in each of the two treatment groups were included in this analysis.
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description:
Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab placebo administered subcutaneously once a week
Overall Number of Participants Analyzed 272 272
Least Squares Mean (Standard Error)
Unit of Measure: units on a scale
Week 58 Number Analyzed 101 participants 104 participants
6.07  (1.015) 3.62  (1.010)
Week 106 Number Analyzed 48 participants 37 participants
10.34  (1.425) 6.54  (1.559)
Week 130 Number Analyzed 10 participants 10 participants
18.10  (2.424) 1.08  (2.473)
Time Frame 30 days post last study treatment (up to 148 weeks)
Adverse Event Reporting Description Safety Analysis Set included all randomized participants who received at least 1 dose of study drug and was analyzed according to treatment received.
 
Arm/Group Title Simtuzumab Simtuzumab Placebo
Hide Arm/Group Description Simtuzumab 125 mg/mL administered subcutaneously once a week Simtuzumab placebo administered subcutaneously once a week
All-Cause Mortality
Simtuzumab Simtuzumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   31/271 (11.44%)   32/272 (11.76%) 
Show Serious Adverse Events Hide Serious Adverse Events
Simtuzumab Simtuzumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   101/271 (37.27%)   97/272 (35.66%) 
Blood and lymphatic system disorders     
Anaemia  1  1/271 (0.37%)  0/272 (0.00%) 
Pancytopenia  1  0/271 (0.00%)  1/272 (0.37%) 
Cardiac disorders     
Acute myocardial infarction  1  3/271 (1.11%)  5/272 (1.84%) 
Acute right ventricular failure  1  0/271 (0.00%)  1/272 (0.37%) 
Angina pectoris  1  2/271 (0.74%)  0/272 (0.00%) 
Aortic valve stenosis  1  0/271 (0.00%)  1/272 (0.37%) 
Atrial fibrillation  1  6/271 (2.21%)  1/272 (0.37%) 
Atrial flutter  1  2/271 (0.74%)  0/272 (0.00%) 
Cardiac arrest  1  1/271 (0.37%)  0/272 (0.00%) 
Cardiac failure  1  0/271 (0.00%)  2/272 (0.74%) 
Cardiac failure congestive  1  1/271 (0.37%)  0/272 (0.00%) 
Cardio-respiratory arrest  1  1/271 (0.37%)  0/272 (0.00%) 
Cardiomyopathy  1  1/271 (0.37%)  0/272 (0.00%) 
Coronary artery disease  1  1/271 (0.37%)  3/272 (1.10%) 
Coronary artery occlusion  1  1/271 (0.37%)  1/272 (0.37%) 
Myocardial ischaemia  1  1/271 (0.37%)  0/272 (0.00%) 
Pleuropericarditis  1  1/271 (0.37%)  0/272 (0.00%) 
Right ventricular dysfunction  1  0/271 (0.00%)  1/272 (0.37%) 
Right ventricular failure  1  1/271 (0.37%)  0/272 (0.00%) 
Supraventricular tachycardia  1  2/271 (0.74%)  0/272 (0.00%) 
Gastrointestinal disorders     
Abdominal pain  1  0/271 (0.00%)  1/272 (0.37%) 
Abdominal pain upper  1  1/271 (0.37%)  0/272 (0.00%) 
Colitis ulcerative  1  1/271 (0.37%)  0/272 (0.00%) 
Diverticulum intestinal haemorrhagic  1  1/271 (0.37%)  0/272 (0.00%) 
Gastritis  1  0/271 (0.00%)  1/272 (0.37%) 
Melaena  1  1/271 (0.37%)  0/272 (0.00%) 
Mesenteric venous occlusion  1  1/271 (0.37%)  0/272 (0.00%) 
Oesophageal varices haemorrhage  1  0/271 (0.00%)  1/272 (0.37%) 
Pancreatitis  1  0/271 (0.00%)  1/272 (0.37%) 
Pancreatitis acute  1  1/271 (0.37%)  2/272 (0.74%) 
Rectal haemorrhage  1  1/271 (0.37%)  0/272 (0.00%) 
Small intestinal obstruction  1  0/271 (0.00%)  1/272 (0.37%) 
Upper gastrointestinal haemorrhage  1  1/271 (0.37%)  0/272 (0.00%) 
General disorders     
Asthenia  1  1/271 (0.37%)  2/272 (0.74%) 
Chest discomfort  1  1/271 (0.37%)  0/272 (0.00%) 
Chest pain  1  2/271 (0.74%)  3/272 (1.10%) 
Death  1  1/271 (0.37%)  0/272 (0.00%) 
Fatigue  1  2/271 (0.74%)  0/272 (0.00%) 
General physical health deterioration  1  2/271 (0.74%)  0/272 (0.00%) 
Pyrexia  1  2/271 (0.74%)  0/272 (0.00%) 
Hepatobiliary disorders     
Cholecystitis  1  0/271 (0.00%)  2/272 (0.74%) 
Cholecystitis acute  1  4/271 (1.48%)  1/272 (0.37%) 
Cholelithiasis  1  2/271 (0.74%)  0/272 (0.00%) 
Hepatic mass  1  0/271 (0.00%)  1/272 (0.37%) 
Hepatic necrosis  1  0/271 (0.00%)  1/272 (0.37%) 
Infections and infestations     
Appendicitis  1  0/271 (0.00%)  1/272 (0.37%) 
Bacteraemia  1  2/271 (0.74%)  0/272 (0.00%) 
Bronchitis  1  2/271 (0.74%)  0/272 (0.00%) 
Cellulitis  1  0/271 (0.00%)  1/272 (0.37%) 
Endocarditis  1  1/271 (0.37%)  0/272 (0.00%) 
Furuncle  1  0/271 (0.00%)  1/272 (0.37%) 
Gastroenteritis  1  1/271 (0.37%)  1/272 (0.37%) 
Hepatitis E  1  0/271 (0.00%)  1/272 (0.37%) 
Influenza  1  1/271 (0.37%)  0/272 (0.00%) 
Intervertebral discitis  1  1/271 (0.37%)  0/272 (0.00%) 
Lower respiratory tract infection  1  0/271 (0.00%)  4/272 (1.47%) 
Lung infection  1  0/271 (0.00%)  1/272 (0.37%) 
Mycetoma mycotic  1  0/271 (0.00%)  1/272 (0.37%) 
Oropharyngitis fungal  1  0/271 (0.00%)  1/272 (0.37%) 
Osteomyelitis  1  1/271 (0.37%)  0/272 (0.00%) 
Pneumonia  1  16/271 (5.90%)  18/272 (6.62%) 
Pneumonia klebsiella  1  0/271 (0.00%)  1/272 (0.37%) 
Pulmonary tuberculosis  1  1/271 (0.37%)  0/272 (0.00%) 
Pyelonephritis  1  0/271 (0.00%)  1/272 (0.37%) 
Respiratory moniliasis  1  0/271 (0.00%)  1/272 (0.37%) 
Respiratory syncytial virus infection  1  0/271 (0.00%)  1/272 (0.37%) 
Respiratory tract infection  1  0/271 (0.00%)  3/272 (1.10%) 
Sepsis  1  1/271 (0.37%)  1/272 (0.37%) 
Upper respiratory tract infection  1  1/271 (0.37%)  1/272 (0.37%) 
Urinary tract infection  1  3/271 (1.11%)  0/272 (0.00%) 
Urosepsis  1  1/271 (0.37%)  0/272 (0.00%) 
Injury, poisoning and procedural complications     
Contusion  1  0/271 (0.00%)  1/272 (0.37%) 
Femur fracture  1  1/271 (0.37%)  0/272 (0.00%) 
Ligament sprain  1  0/271 (0.00%)  1/272 (0.37%) 
Post procedural stroke  1  0/271 (0.00%)  1/272 (0.37%) 
Rib fracture  1  0/271 (0.00%)  1/272 (0.37%) 
Spinal compression fracture  1  0/271 (0.00%)  1/272 (0.37%) 
Investigations     
Blood creatinine increased  1  1/271 (0.37%)  0/272 (0.00%) 
Blood urea increased  1  1/271 (0.37%)  0/272 (0.00%) 
Ejection fraction decreased  1  0/271 (0.00%)  1/272 (0.37%) 
International normalised ratio increased  1  1/271 (0.37%)  0/272 (0.00%) 
Metabolism and nutrition disorders     
Diabetic ketoacidosis  1  0/271 (0.00%)  1/272 (0.37%) 
Type 2 diabetes mellitus  1  0/271 (0.00%)  1/272 (0.37%) 
Musculoskeletal and connective tissue disorders     
Intervertebral disc protrusion  1  0/271 (0.00%)  1/272 (0.37%) 
Musculoskeletal chest pain  1  0/271 (0.00%)  1/272 (0.37%) 
Rheumatoid arthritis  1  1/271 (0.37%)  0/272 (0.00%) 
Rotator cuff syndrome  1  1/271 (0.37%)  1/272 (0.37%) 
Spinal column stenosis  1  1/271 (0.37%)  0/272 (0.00%) 
Spondylolysis  1  0/271 (0.00%)  1/272 (0.37%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)     
Basal cell carcinoma  1  1/271 (0.37%)  0/272 (0.00%) 
Bronchioloalveolar carcinoma  1  0/271 (0.00%)  1/272 (0.37%) 
Colon cancer  1  0/271 (0.00%)  1/272 (0.37%) 
Gastrointestinal carcinoma  1  0/271 (0.00%)  1/272 (0.37%) 
Lung cancer metastatic  1  1/271 (0.37%)  0/272 (0.00%) 
Lung neoplasm malignant  1  1/271 (0.37%)  1/272 (0.37%) 
Malignant melanoma  1  0/271 (0.00%)  1/272 (0.37%) 
Metastases to liver  1  0/271 (0.00%)  1/272 (0.37%) 
Metastases to lung  1  0/271 (0.00%)  1/272 (0.37%) 
Non-small cell lung cancer  1  1/271 (0.37%)  0/272 (0.00%) 
Oesophageal carcinoma  1  0/271 (0.00%)  1/272 (0.37%) 
Squamous cell carcinoma of lung  1  1/271 (0.37%)  1/272 (0.37%) 
Squamous cell carcinoma of the tongue  1  1/271 (0.37%)  0/272 (0.00%) 
Nervous system disorders     
Amnesia  1  1/271 (0.37%)  0/272 (0.00%) 
Carotid artery stenosis  1  0/271 (0.00%)  1/272 (0.37%) 
Chronic inflammatory demyelinating polyradiculoneuropathy  1  0/271 (0.00%)  1/272 (0.37%) 
Dizziness  1  1/271 (0.37%)  0/272 (0.00%) 
Facial paresis  1  0/271 (0.00%)  1/272 (0.37%) 
Hypoaesthesia  1  0/271 (0.00%)  1/272 (0.37%) 
Ischaemic stroke  1  0/271 (0.00%)  1/272 (0.37%) 
Polyneuropathy  1  1/271 (0.37%)  0/272 (0.00%) 
Presyncope  1  0/271 (0.00%)  1/272 (0.37%) 
Seizure  1  0/271 (0.00%)  1/272 (0.37%) 
Syncope  1  2/271 (0.74%)  2/272 (0.74%) 
Transient ischaemic attack  1  2/271 (0.74%)  2/272 (0.74%) 
VIth nerve paralysis  1  0/271 (0.00%)  1/272 (0.37%) 
Renal and urinary disorders     
Acute kidney injury  1  1/271 (0.37%)  0/272 (0.00%) 
Calculus urinary  1  0/271 (0.00%)  1/272 (0.37%) 
Glomerulonephritis  1  1/271 (0.37%)  0/272 (0.00%) 
Goodpasture's syndrome  1  1/271 (0.37%)  0/272 (0.00%) 
Haematuria  1  0/271 (0.00%)  1/272 (0.37%) 
Respiratory, thoracic and mediastinal disorders     
Acute respiratory failure  1  6/271 (2.21%)  1/272 (0.37%) 
Cough  1  1/271 (0.37%)  1/272 (0.37%) 
Dyspnoea  1  10/271 (3.69%)  7/272 (2.57%) 
Dyspnoea exertional  1  0/271 (0.00%)  1/272 (0.37%) 
Haemoptysis  1  0/271 (0.00%)  1/272 (0.37%) 
Hypoxia  1  3/271 (1.11%)  2/272 (0.74%) 
Idiopathic pulmonary fibrosis  1  31/271 (11.44%)  35/272 (12.87%) 
Interstitial lung disease  1  0/271 (0.00%)  1/272 (0.37%) 
Lung disorder  1  0/271 (0.00%)  1/272 (0.37%) 
Nasal polyps  1  1/271 (0.37%)  0/272 (0.00%) 
Pleural effusion  1  0/271 (0.00%)  1/272 (0.37%) 
Pleurisy  1  1/271 (0.37%)  0/272 (0.00%) 
Pneumothorax  1  2/271 (0.74%)  3/272 (1.10%) 
Pulmonary alveolar haemorrhage  1  1/271 (0.37%)  0/272 (0.00%) 
Pulmonary embolism  1  1/271 (0.37%)  3/272 (1.10%) 
Pulmonary fibrosis  1  3/271 (1.11%)  0/272 (0.00%) 
Pulmonary hypertension  1  1/271 (0.37%)  0/272 (0.00%) 
Pulmonary oedema  1  1/271 (0.37%)  0/272 (0.00%) 
Respiratory disorder  1  1/271 (0.37%)  0/272 (0.00%) 
Respiratory distress  1  1/271 (0.37%)  1/272 (0.37%) 
Respiratory failure  1  5/271 (1.85%)  4/272 (1.47%) 
Tachypnoea  1  1/271 (0.37%)  0/272 (0.00%) 
Skin and subcutaneous tissue disorders     
Diabetic foot  1  0/271 (0.00%)  1/272 (0.37%) 
Vascular disorders     
Aortic stenosis  1  2/271 (0.74%)  1/272 (0.37%) 
Circulatory collapse  1  0/271 (0.00%)  1/272 (0.37%) 
Deep vein thrombosis  1  1/271 (0.37%)  1/272 (0.37%) 
Femoral artery occlusion  1  0/271 (0.00%)  1/272 (0.37%) 
Hypertension  1  1/271 (0.37%)  0/272 (0.00%) 
Peripheral ischaemia  1  0/271 (0.00%)  1/272 (0.37%) 
Peripheral vascular disorder  1  0/271 (0.00%)  1/272 (0.37%) 
Vasculitis  1  1/271 (0.37%)  0/272 (0.00%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Simtuzumab Simtuzumab Placebo
Affected / at Risk (%) Affected / at Risk (%)
Total   237/271 (87.45%)   246/272 (90.44%) 
Gastrointestinal disorders     
Constipation  1  16/271 (5.90%)  13/272 (4.78%) 
Diarrhoea  1  44/271 (16.24%)  47/272 (17.28%) 
Gastrooesophageal reflux disease  1  21/271 (7.75%)  22/272 (8.09%) 
Nausea  1  33/271 (12.18%)  35/272 (12.87%) 
General disorders     
Asthenia  1  15/271 (5.54%)  17/272 (6.25%) 
Chest pain  1  18/271 (6.64%)  16/272 (5.88%) 
Fatigue  1  49/271 (18.08%)  48/272 (17.65%) 
Injection site bruising  1  17/271 (6.27%)  10/272 (3.68%) 
Oedema peripheral  1  21/271 (7.75%)  12/272 (4.41%) 
Pyrexia  1  21/271 (7.75%)  12/272 (4.41%) 
Infections and infestations     
Bronchitis  1  32/271 (11.81%)  39/272 (14.34%) 
Lower respiratory tract infection  1  8/271 (2.95%)  15/272 (5.51%) 
Nasopharyngitis  1  36/271 (13.28%)  43/272 (15.81%) 
Respiratory tract infection  1  14/271 (5.17%)  17/272 (6.25%) 
Sinusitis  1  16/271 (5.90%)  14/272 (5.15%) 
Upper respiratory tract infection  1  57/271 (21.03%)  57/272 (20.96%) 
Investigations     
Weight decreased  1  25/271 (9.23%)  24/272 (8.82%) 
Metabolism and nutrition disorders     
Decreased appetite  1  29/271 (10.70%)  34/272 (12.50%) 
Musculoskeletal and connective tissue disorders     
Arthralgia  1  35/271 (12.92%)  22/272 (8.09%) 
Back pain  1  27/271 (9.96%)  28/272 (10.29%) 
Pain in extremity  1  9/271 (3.32%)  14/272 (5.15%) 
Nervous system disorders     
Dizziness  1  31/271 (11.44%)  26/272 (9.56%) 
Headache  1  32/271 (11.81%)  35/272 (12.87%) 
Psychiatric disorders     
Depression  1  14/271 (5.17%)  12/272 (4.41%) 
Insomnia  1  15/271 (5.54%)  17/272 (6.25%) 
Respiratory, thoracic and mediastinal disorders     
Cough  1  102/271 (37.64%)  93/272 (34.19%) 
Dyspnoea  1  98/271 (36.16%)  73/272 (26.84%) 
Dyspnoea exertional  1  30/271 (11.07%)  29/272 (10.66%) 
Epistaxis  1  16/271 (5.90%)  9/272 (3.31%) 
Idiopathic pulmonary fibrosis  1  33/271 (12.18%)  27/272 (9.93%) 
Oropharyngeal pain  1  16/271 (5.90%)  15/272 (5.51%) 
Productive cough  1  22/271 (8.12%)  18/272 (6.62%) 
Rhinorrhoea  1  19/271 (7.01%)  15/272 (5.51%) 
Sputum increased  1  14/271 (5.17%)  4/272 (1.47%) 
Skin and subcutaneous tissue disorders     
Pruritus  1  17/271 (6.27%)  8/272 (2.94%) 
Rash  1  22/271 (8.12%)  21/272 (7.72%) 
Vascular disorders     
Hypertension  1  15/271 (5.54%)  12/272 (4.41%) 
1
Term from vocabulary, MedDRA 18.0
Indicates events were collected by systematic assessment
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.

After conclusion of the study and without prior written approval from Gilead, investigators in this study may communicate, orally present, or publish in scientific journals or other media only after the following conditions have been met:

  • The results of the study in their entirety have been publicly disclosed by or with the consent of Gilead in an abstract, manuscript, or presentation form; or
  • The study has been completed at all study sites for at least 2 years
Results Point of Contact
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
Publications of Results:
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.
Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01769196     History of Changes
Other Study ID Numbers: GS-US-322-0207
2012-001571-36 ( EudraCT Number )
First Submitted: January 14, 2013
First Posted: January 16, 2013
Results First Submitted: February 22, 2017
Results First Posted: April 13, 2017
Last Update Posted: May 30, 2017