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
  Purpose

The purpose of this study is to determine if Simtuzumab (GS-6624) is safe and effective in treating Idiopathic Pulmonary Fibrosis


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab (GS-6624)
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: February 2018
Estimated Primary Completion Date: February 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab (GS-6624)
Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
Drug: Simtuzumab (GS-6624)
Simtuzumab (GS-6624),125 mg/mL, single dose vials, subcutaneous, weekly
Other Name: GS-6624
Placebo Comparator: Placebo
Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly
Drug: Placebo
Sterile, clear water solution,125 mg/mL, single dose vials, subcutaneous, weekly

  Eligibility

Ages Eligible for Study:   45 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01769196

Contacts
Contact: Tom O'Riordan, MD 206-832-2197 thomas.oriordan@gilead.com
Contact: Selina Bayly 206-256-4956 selina.bayly@gilead.com

  Show 187 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Chair: Ganesh Raghu, MD, FCCP, FACP University of Washington
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01769196     History of Changes
Other Study ID Numbers: GS-US-322-0207, 2012-001571-36
Study First Received: January 14, 2013
Last Updated: April 11, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Idiopathic
Pulmonary
Fibrosis
IPF

Additional relevant MeSH terms:
Fibrosis
Pulmonary Fibrosis
Idiopathic Pulmonary Fibrosis
Pathologic Processes
Lung Diseases
Respiratory Tract Diseases
Idiopathic Interstitial Pneumonias
Lung Diseases, Interstitial

ClinicalTrials.gov processed this record on April 15, 2014