Long-Term Safety Study of GS-6624 to Treat Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01759511
First received: November 15, 2012
Last updated: September 18, 2014
Last verified: September 2014
  Purpose

This study is to evaluate the long term safety and tolerability of simtuzumab (GS-6624) in participants with Idiopathic Pulmonary Fibrosis (IPF) who had previously participated in Gilead clinical trial AB0024-201.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: Simtuzumab
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • Number of participants with Adverse Events as a measure for safety and tolerability [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in Forced Vital Capacity (FVC) [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
    FVC is a pulmonary function test, and is defined as the volume of air that can forcibly be blown out after taking a full breath.

  • Change in Diffusing Lung Capacity for Carbon Monoxide (DLCO) [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
    DLCO is a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.

  • All-cause mortality [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]
    All-cause mortality will be assessed as a percentage of participants who die from any cause.

  • Change in serum LOXL2 levels [ Time Frame: Baseline to Year 3 ] [ Designated as safety issue: No ]

Estimated Enrollment: 48
Study Start Date: October 2012
Estimated Study Completion Date: June 2019
Estimated Primary Completion Date: January 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab
Participants will receive simtuzumab every 7 days
Drug: Simtuzumab
Simtuzumab 125 mg/mL administered subcutaneously
Other Name: GS-6624

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Previous participation in Phase 1 Gilead clinical trial
  • Diagnosis of Idiopathic Pulmonary Fibrosis
  • Females of childbearing potential and non-vasectomized males must agree to use highly effective methods of contraception
  • Females must discontinue nursing
  • Comply with study requirements
  • Have adequate organ function

Exclusion Criteria:

  • History or evidence of clinically significant disorder, condition or disease that would pose a risk or interfere with the study
  • Pregnant or lactating
  • Clinically significant heart, hepatic or renal disease
  • History of cancer within 5 years of screening
  • Infection that is not controlled despite antibiotics or other treatment
  • History of bleeding diathesis within the last 6 months of Day 1
  • Known history of Human Immunodeficiency Virus, hepatitis B or C
  • Concern's for subjects compliance
  • Other conditions that might put the subject at high risk for treatment complications or reduce the chance to obtain data required
  • Placed on a lung transplant list
  • Previous participation in an Idiopathic Pulmonary Fibrosis clinical trial other than for Gilead Sciences -6624
  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: NCT01759511

Locations
United States, Arizona
Arizona Pulmonary Specialists, Ltd.
Scottsdale, Arizona, United States, 85012
United States, California
University of California
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Pennsylvania
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States, 15213
United States, South Carolina
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
United States, Tennessee
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37232
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: NCT01759511     History of Changes
Other Study ID Numbers: GS-US-322-0206
Study First Received: November 15, 2012
Last Updated: September 18, 2014
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Idiopathic
Pulmonary
Fibrosis
IPF

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

ClinicalTrials.gov processed this record on October 21, 2014