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

A Phase 2, Long-Term Safety Study of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis (IPF)

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.

Study Overview

• Status: Terminated
• Conditions: Idiopathic Pulmonary Fibrosis
• Intervention / Treatment: Drug: Simtuzumab

• Study Type: Interventional
• Enrollment (Actual): 34
• Phase: Phase 2

Contacts and Locations

Study Locations

• United States
  • Arizona
    • Scottsdale, Arizona, United States, 85012
      • Arizona Pulmonary Specialists, Ltd.
  • California
    • Los Angeles, California, United States, 90095
      • University of California
    • Stanford, California, United States, 94305
      • Stanford University Medical Center
  • Pennsylvania
    • Pittsburgh, Pennsylvania, United States, 15213
      • University of Pittsburgh Medical Center
  • South Carolina
    • Charleston, South Carolina, United States, 29425
      • Medical University of South Carolina
  • Tennessee
    • Nashville, Tennessee, United States, 37232
      • Vanderbilt University Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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 Names: GS-6624

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	30 days post last study treatment (up to 165 weeks)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Weeks 72 and 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.	Weeks 72 and 144
All-cause Mortality	All-cause mortality was assessed as a number of participants who died from any cause.	Up to 165 weeks
Relative Change From Baseline in Serum Lysyl Oxidase-like 2 (sLOXL2) Levels at Weeks 72 and 120		Weeks 72 and 120

Collaborators and Investigators

• Sponsor: Gilead Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 18, 2012
• Primary Completion (Actual): February 19, 2016
• Study Completion (Actual): February 19, 2016

Study Registration Dates

• First Submitted: November 15, 2012
• First Submitted That Met QC Criteria: December 29, 2012
• First Posted (Estimate): January 3, 2013

Study Record Updates

• Last Update Posted (Actual): April 4, 2017
• Last Update Submitted That Met QC Criteria: February 17, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Fibrosis; Pulmonary; IPF; Idiopathic
• Additional Relevant MeSH Terms: Pathologic Processes; Respiratory Tract Diseases; Lung Diseases; Fibrosis; Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis
• Other Study ID Numbers: GS-US-322-0206

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No