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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. (see Contacts and Locations)
Verified July 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: July 9, 2014
Last verified: July 2014

January 14, 2013
July 9, 2014
February 2013
January 2018   (final data collection date for primary outcome measure)
  • Progression free survival [ Time Frame: Up to 254 weeks ] [ 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).
  • PFS among participants with "high" serum levels of lysyl oxidase-like 2 (sLOXL2) at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants as sLOXL2 high and low will be specified in the interim and final statistical analysis plan before un-blinding of the study.
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: Up to 254 weeks ] [ Designated as safety issue: No ]
    From the date of randomization to the date of death from any cause, assessed up to 254 weeks.
  • All-cause mortality among participants with "high" sLOXL2 at baseline [ Time Frame: Up to 254 weeks ] [ Designated as safety issue: No ]
    A cut-off to classify participants 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)

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with 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 administered subcutaneously weekly
    Other Name: GS-6624
  • Drug: Placebo to match simtuzumab
    Placebo to match simtuzumab single-dose vials administered subcutaneously weekly
  • Experimental: Simtuzumab (GS-6624)
    Participants will receive simtuzumab (GS-6624) for up to 254 weeks.
    Intervention: Drug: Simtuzumab (GS-6624)
  • Placebo Comparator: Placebo to match simtuzumab
    Participants will receive placebo to match simtuzumab for up to 254 weeks.
    Intervention: Drug: Placebo to match simtuzumab
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
500
January 2018
January 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 Director: Thomas O'Riordan, MD Gilead Sciences
Gilead Sciences
July 2014

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