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

This study is currently recruiting participants.
Verified April 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: April 11, 2014
Last verified: April 2014

January 14, 2013
April 11, 2014
February 2013
February 2018   (final data collection date for primary outcome measure)
Progression free survival [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
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 182 weeks.
Progression free survival [ Time Frame: 182 weeks ] [ Designated as safety issue: No ]
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
  • All-cause mortality [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    From the date of randomization to the date of death from any cause, assessed up to 182 weeks.
  • PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    A cut-off to classify patients as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.
  • All-cause mortality among subjects with "high" sLOXL2 at baseline [ Time Frame: Baseline to Week 182 ] [ Designated as safety issue: No ]
    A cut-off to classify patients as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.
All-cause mortality [ Time Frame: 182 weeks ] [ Designated as safety issue: No ]
From the date of randomization to the date of death from any cause, assessed up to 182 weeks.
Not Provided
Not Provided
 
A Phase 2 Study to See if Simtuzumab (GS-6624) is Safe and Works in 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 purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis

Not Provided
Interventional
Phase 2
Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Idiopathic Pulmonary Fibrosis
  • Drug: Simtuzumab (GS-6624)
    Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
    Other Name: GS-6624
  • Drug: Placebo
    Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly
  • Experimental: Simtuzumab (GS-6624)
    Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
    Intervention: Drug: Simtuzumab (GS-6624)
  • Placebo Comparator: Placebo
    Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly
    Intervention: Drug: Placebo
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
February 2018
February 2018   (final data collection date for primary outcome measure)

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
  • Listed as active on a lung transplant waiting list
Both
45 Years to 85 Years
No
Contact: Tom O'Riordan, MD 206-832-2197 thomas.oriordan@gilead.com
Contact: Selina Bayly 206-256-4956 selina.bayly@gilead.com
United States,   Australia,   Belgium,   Canada,   Czech Republic,   France,   Germany,   Israel,   Italy,   Korea, Republic of,   Poland,   Spain,   Switzerland,   United Kingdom
 
NCT01769196
GS-US-322-0207, 2012-001571-36
Yes
Gilead Sciences
Gilead Sciences
Not Provided
Study Chair: Ganesh Raghu, MD, FCCP, FACP University of Washington
Gilead Sciences
April 2014

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