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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 August 2014 by Gilead Sciences
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01769196
First received: January 14, 2013
Last updated: August 13, 2014
Last verified: August 2014
  Purpose

This study is to evaluate the efficacy and safety of simtuzumab (GS-6624) in adults with idiopathic pulmonary fibrosis.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab (GS-6624)
Drug: Placebo to match simtuzumab
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: 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.


Secondary Outcome Measures:
  • 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.


Estimated Enrollment: 500
Study Start Date: February 2013
Estimated Study Completion Date: January 2018
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab (GS-6624)
Participants will receive simtuzumab (GS-6624) for up to 254 weeks.
Drug: Simtuzumab (GS-6624)
Simtuzumab (GS-6624) 125 mg/mL single-dose vials administered subcutaneously weekly
Other Name: GS-6624
Placebo Comparator: Placebo to match simtuzumab
Participants will receive placebo to match simtuzumab for up to 254 weeks.
Drug: Placebo to match simtuzumab
Placebo to match simtuzumab single-dose vials administered subcutaneously 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
  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

  Show 187 Study Locations
Sponsors and Collaborators
Gilead Sciences
Investigators
Study Director: Thomas O'Riordan, MD Gilead Sciences
  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: August 13, 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 September 18, 2014