Back to resultsLong-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF) (ATLAS)
Primary Purpose
Idiopathic Pulmonary Fibrosis
Status
Terminated
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Simtuzumab
Sponsored by
About this trial
This is an interventional treatment trial for Idiopathic Pulmonary Fibrosis focused on measuring Idiopathic, Pulmonary, Fibrosis, IPF
Eligibility 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
Sites / Locations
- Arizona Pulmonary Specialists, Ltd.
- University of California
- Stanford University Medical Center
- University of Pittsburgh Medical Center
- Medical University of South Carolina
- Vanderbilt University Medical Center
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Simtuzumab
Arm Description
Participants will receive simtuzumab.
Outcomes
Primary Outcome Measures
Overall Safety Profile of Simtuzumab
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
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
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
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
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01759511
Brief Title
Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Acronym
ATLAS
Official Title
A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)
Study Type
Interventional
2. Study Status
Record Verification Date
February 2017
Overall Recruitment Status
Terminated
Why Stopped
The Study was terminated due to lack of efficacy.
Study Start Date
October 18, 2012 (Actual)
Primary Completion Date
February 19, 2016 (Actual)
Study Completion Date
February 19, 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Idiopathic, Pulmonary, Fibrosis, IPF
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
34 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Simtuzumab
Arm Type
Experimental
Arm Description
Participants will receive simtuzumab.
Intervention Type
Drug
Intervention Name(s)
Simtuzumab
Other Intervention Name(s)
GS-6624
Intervention Description
200 mg/mL administered intravenously biweekly (per original protocol) or 125 mg/mL self-administered subcutaneously every 7 ± 2 days (per protocol amendment 1)
Primary Outcome Measure Information:
Title
Overall Safety Profile of Simtuzumab
Description
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.
Time Frame
30 days post last study treatment (up to 165 weeks)
Secondary Outcome Measure Information:
Title
Relative Change From Baseline in FVC % Predicted at Weeks 72 and 144
Description
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.
Time Frame
Weeks 72 and 144
Title
Relative Change From Baseline in DLCO % Predicted at Weeks 72 and 144
Description
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.
Time Frame
Weeks 72 and 144
Title
All-cause Mortality
Description
All-cause mortality was assessed as a number of participants who died from any cause.
Time Frame
Up to 165 weeks
Title
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120
Time Frame
Weeks 72 and 120
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Gilead Study Director
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Pulmonary Specialists, Ltd.
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85012
Country
United States
Facility Name
University of California
City
Los Angeles
State/Province
California
ZIP/Postal Code
90095
Country
United States
Facility Name
Stanford University Medical Center
City
Stanford
State/Province
California
ZIP/Postal Code
94305
Country
United States
Facility Name
University of Pittsburgh Medical Center
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Medical University of South Carolina
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Long-Term Safety Study of GS-6624 in Adults With Idiopathic Pulmonary Fibrosis (IPF)
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