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Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)

This study has been terminated.
(The Study was terminated due to lack of efficacy.)
Sponsor:
ClinicalTrials.gov Identifier:
NCT01759511
First Posted: January 3, 2013
Last Update Posted: April 4, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Gilead Sciences
  Purpose
The primary objective of 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: Intervention Model: Single Group Assignment
Masking: None (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:
  • Overall Safety Profile of Simtuzumab [ Time Frame: 30 days post last study treatment (up to 165 weeks) ]
    The overall safety of simtuzumab was assessed as the percentage of participants experiencing adverse events (AEs; Serious AEs, Grade 3 or 4 AEs, AEs related to simtuzumab, and AEs leading to discontinuation of simtuzumab), treatment-emergent chemistry and hematology abnormality.


Secondary Outcome Measures:
  • Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144 [ Time Frame: Weeks 72 and 144 ]
    • FVC was a pulmonary function test, and was defined as the volume of air that can forcibly be blown out after taking a full breath.
    • Least square means were from mixed model for repeated measures (MMRM) model including baseline FVC % predicted and visit including all data up to Week 144.

  • Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144 [ Time Frame: Weeks 72 and 144 ]
    • DLCO was a measurement to determine the extent to which oxygen passes from the air sacs of the lungs into the blood.
    • Least square means were from MMRM model including baseline DLCO % predicted and visit including all data up to Week 144.

  • All-cause Mortality [ Time Frame: Up to 165 weeks ]
    All-cause mortality was assessed as a number of participants who died from any cause.

  • Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 [ Time Frame: Weeks 72 and 120 ]

Enrollment: 34
Actual Study Start Date: October 18, 2012
Study Completion Date: February 19, 2016
Primary Completion Date: February 19, 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Simtuzumab
Participants will receive simtuzumab.
Drug: Simtuzumab
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Other Name: GS-6624

  Eligibility

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Key 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

Key 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 simtuzumab

Note: Other protocol defined Inclusion/Exclusion criteria may apply

  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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: Gilead Study Director Gilead Sciences
  More Information

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01759511     History of Changes
Other Study ID Numbers: GS-US-322-0206
First Submitted: November 15, 2012
First Posted: January 3, 2013
Results First Submitted: February 17, 2017
Results First Posted: April 4, 2017
Last Update Posted: April 4, 2017
Last Verified: February 2017

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Gilead Sciences:
Idiopathic
Pulmonary
Fibrosis
IPF

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