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

• ClinicalTrials.gov Identifier: NCT01759511
• Recruitment Status: Terminated
• First Posted: January 3, 2013
• Results First Posted: April 4, 2017
• Last Update Posted: April 4, 2017
• Sponsor: Gilead Sciences
• Information provided by (Responsible Party): Gilead Sciences

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.

Condition or disease	Intervention/treatment	Phase
Idiopathic Pulmonary Fibrosis	Drug: Simtuzumab	Phase 2

Study Design

• Study Type: Interventional (Clinical Trial)
• Actual Enrollment: 34 participants
• Allocation: N/A
• 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)
• Actual Study Start Date: October 18, 2012
• Actual Primary Completion Date: February 19, 2016
• Actual Study Completion Date: February 19, 2016

Arms and Interventions

Arm	Intervention/treatment
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

Outcome Measures

Primary Outcome Measures :

1. 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 :

1. 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.
2. 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.
3. All-cause Mortality [ Time Frame: Up to 165 weeks ]
   All-cause mortality was assessed as a number of participants who died from any cause.
4. Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120 [ Time Frame: Weeks 72 and 120 ]

Eligibility Criteria

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• 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

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
• Other Study ID Numbers: GS-US-322-0206
• First Posted: January 3, 2013
• 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:

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis; Pathologic Processes; Lung Diseases; Respiratory Tract Diseases