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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:
ClinicalTrials.gov Identifier:
NCT01769196
First Posted: January 16, 2013
Last Update Posted: May 30, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
January 14, 2013
January 16, 2013
February 22, 2017
April 13, 2017
May 30, 2017
January 31, 2013
February 23, 2016   (Final data collection date for primary outcome measure)
  • Progression Free Survival [ Time Frame: Up to 148 weeks ]
    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.
  • 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 ]
Progression Free Survival [ Time Frame: 182 weeks ]
From date of randomization until the date of first documented progression assessed by a categorical decrease in FVC % predicted (>10% relative decrease in FVC and >5% absolute decrease in FVC) up to 182 weeks.
Complete list of historical versions of study NCT01769196 on ClinicalTrials.gov Archive Site
  • Overall Survival (OS) [ Time Frame: Up to 151 weeks ]
    Overall survival was defined as the time from randomization date to death that occurred prior to the last dose date plus 30 days.
  • 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 [ Time Frame: Weeks 54, 106, and 130 ]
    • 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.
  • 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) [ Time Frame: Weeks 58, 106, and 130 ]
    • 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.
  • Absolute Change From Baseline in St. George's Respiratory Questionnaire (SGRQ) Score [ Time Frame: Week 58, 106, and 130 ]
    • 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.
All-cause mortality [ Time Frame: 182 weeks ]
From the date of randomization to the date of death from any cause, assessed up to 182 weeks.
Not Provided
Not Provided
 
Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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)
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.
Not Provided
Interventional
Phase 2
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: Simtuzumab
    125 mg/mL single-dose vials administered subcutaneously once a week
    Other Name: GS-6624
  • Drug: Simtuzumab placebo
    Simtuzumab placebo single-dose vials administered subcutaneously once a week
  • Experimental: Simtuzumab
    Participants will receive simtuzumab for up to 254 weeks.
    Intervention: Drug: Simtuzumab
  • Placebo Comparator: Simtuzumab Placebo
    Participants will receive simtuzumab placebo for up to 254 weeks.
    Intervention: Drug: Simtuzumab placebo

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
544
February 23, 2016
February 23, 2016   (Final data collection date for primary outcome measure)

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.

Sexes Eligible for Study: All
45 Years to 85 Years   (Adult, Senior)
No
Contact information is only displayed when the study is recruiting subjects
Australia,   Belgium,   Canada,   Czechia,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Poland,   Spain,   Switzerland,   United Kingdom,   United States
Czech Republic
 
NCT01769196
GS-US-322-0207
2012-001571-36 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Not Provided
Gilead Sciences
Gilead Sciences
Not Provided
Study Director: Gilead Study Director Gilead Sciences
Gilead Sciences
April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP