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Trial record 1 of 1 for:    gilead rainier
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Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF) (RAINIER)

This study has been terminated.
(The Study was terminated due to lack of efficacy.)
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: April 28, 2017
Last verified: April 2017
Results First Received: February 22, 2017  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Idiopathic Pulmonary Fibrosis
Interventions: Drug: Simtuzumab
Drug: Simtuzumab placebo

  Participant Flow
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Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
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
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
1250 participants were screened.

Reporting Groups
  Description
Simtuzumab Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab Placebo Simtuzumab placebo administered subcutaneously once a week

Participant Flow:   Overall Study
    Simtuzumab   Simtuzumab Placebo
STARTED   272   272 
COMPLETED   0   0 
NOT COMPLETED   272   272 
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 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
Intent-to-Treat (ITT) Analysis Set included all participants who were randomized into the study, and were analyzed according to treatment randomized.

Reporting Groups
  Description
Simtuzumab Simtuzumab 125 mg/mL administered subcutaneously once a week
Simtuzumab Placebo Simtuzumab placebo administered subcutaneously once a week
Total Total of all reporting groups

Baseline Measures
   Simtuzumab   Simtuzumab Placebo   Total 
Overall Participants Analyzed 
[Units: Participants]
 272   272   544 
Age 
[Units: Years]
Mean (Standard Deviation)
 67.7  (7.60)   68.5  (7.07)   68.1  (7.34) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
     
Female      45  16.5%      47  17.3%      92  16.9% 
Male      227  83.5%      225  82.7%      452  83.1% 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Asian   35   36   71 
Black   3   3   6 
White   231   229   460 
Other   3   4   7 
Race/Ethnicity, Customized 
[Units: Participants]
Count of Participants
     
Hispanic or Latino   5   7   12 
Not Hispanic or Latino   267   264   531 
Not Permitted   0   1   1 
Region of Enrollment 
[Units: Participants]
Count of Participants
     
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 
[Units: FVC % predicted]
Mean (Standard Deviation)
 61.4  (12.17)   62.3  (12.22)   61.8  (12.19) 
FVC % Predicted Category 
[Units: Participants]
Count of Participants
     
Mild   37   46   83 
Moderate   152   150   302 
Severe   83   76   159 
Baseline Serum LOXL2 
[Units: pg/mL]
Mean (Standard Deviation)
 89.8  (70.06)   86.7  (51.99)   88.2  (61.48) 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Progression Free Survival   [ Time Frame: Up to 148 weeks ]

2.  Primary:   PFS Among the Participants With sLOXL2 ≥ 50th Percentile   [ Time Frame: Up to 148 weeks ]

3.  Primary:   PFS Among the Participants With sLOXL2 ≥ 75th Percentile   [ Time Frame: Up to 148 weeks ]

4.  Secondary:   Overall Survival (OS)   [ Time Frame: Up to 151 weeks ]

5.  Secondary:   Overall Survival Among the Participants With sLOXL2 ≥ 50th Percentile   [ Time Frame: Up to 151 weeks ]

6.  Secondary:   Overall Survival Among the Participants With sLOXL2 ≥ 75th Percentile   [ Time Frame: Up to 151 weeks ]

7.  Secondary:   Relative Change From Baseline in FVC % Predicted   [ Time Frame: Weeks 54, 106, and 130 ]

8.  Secondary:   Definite Acute Exacerbations of IPF Among Adjudicated Respiratory Hospitalizations   [ Time Frame: Up to 148 weeks ]

9.  Secondary:   Number of Adjudicated Respiratory Hospitalizations (ARP) Among Total Hospitalizations   [ Time Frame: Up to 148 weeks ]

10.  Secondary:   Number of Participants Experiencing Adjudicated Respiratory Deaths Among Those With Adjudicated Death   [ Time Frame: Up to 148 weeks ]

11.  Secondary:   Absolute Change From Baseline in 6 Minute Walk Distance (6MWD)   [ Time Frame: Weeks 58, 106, and 130 ]

12.  Secondary:   Absolute Change From Baseline in St. George’s Respiratory Questionnaire (SGRQ) Score   [ Time Frame: Week 58, 106, and 130 ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
  Hide Limitations and Caveats

Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
No text entered.


  More Information
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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.
The agreement is:
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is less than or equal to 60 days. The sponsor cannot require changes to the communication and cannot extend the embargo.
unchecked The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding trial results for a period that is more than 60 days but less than or equal to 180 days. The sponsor cannot require changes to the communication and cannot extend the embargo.


Results Point of Contact:  
Name/Title: Clinical Trial Disclosures
Organization: Gilead Sciences
e-mail: ClinicalTrialDisclosures@gilead.com


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.

Other Publications:

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01769196     History of Changes
Other Study ID Numbers: GS-US-322-0207
2012-001571-36 ( EudraCT Number )
Study First Received: January 14, 2013
Results First Received: February 22, 2017
Last Updated: April 28, 2017