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A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

Primary Purpose

Idiopathic Pulmonary Fibrosis

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GS-6624
Sponsored by
Gilead Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Idiopathic Pulmonary Fibrosis focused on measuring Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial

Eligibility Criteria

40 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  1. Acceptable results on pulmonary function tests
  2. At rest oxygen saturation ≥90% on room air
  3. Adequate organ function

Exclusion Criteria:

  1. High resolution computer tomography pattern showing emphysema that is greater than fibrosis
  2. Acceptable results on whole body plethysmography
  3. History of clinically significant hepatic or renal disease
  4. Poorly controlled or severe diabetes mellitus
  5. Use of systemic immunosuppressants within 28 days of GS-6624 infusion

Sites / Locations

  • Arizona Pulmonary Specialists
  • David Geffen School of Medicine at UCLA
  • Stanford University Medical Center
  • Loess Hills Clinical Research Center
  • UPMC Translational Research Center
  • Medical University of South Carolina
  • Vanderbilt University Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

GS-6624 125mg

Experimental: GS-6624 200mg

Arm Description

Outcomes

Primary Outcome Measures

To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).

Secondary Outcome Measures

- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ
Secondary Endpoints: Anti-GS-6624 antibody formation; Change in FVC and DLCO; Change in SGRQ score.

Full Information

First Posted
April 12, 2011
Last Updated
July 7, 2015
Sponsor
Gilead Sciences
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1. Study Identification

Unique Protocol Identification Number
NCT01362231
Brief Title
A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Official Title
A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
Study Type
Interventional

2. Study Status

Record Verification Date
July 2015
Overall Recruitment Status
Completed
Study Start Date
December 2010 (undefined)
Primary Completion Date
December 2012 (Actual)
Study Completion Date
December 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Gilead Sciences

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The study consists of 2 parts: Part A is a randomized, multiple-dose, double-blind, placebo-controlled sequential dose escalation study to evaluate GS-6624 in subjects with Idiopathic Pulmonary Fibrosis (IPF) and was completed in October 2011. Part B is a randomized, two-dose, open-label dose expansion study to evaluate GS-6624 in subjects with IPF and is currently enrolling.
Detailed Description
The primary objective of this study is to characterize the safety, tolerability, and PK of GS-6624 after multiple IV administrations in patients with IPF. The secondary objectives are to evaluate the formation of anti-GS-6624 antibodies and to measure the effects of GS-6624 on FVC, DLCO, and SGRQ score. A total of 48 patients will be enrolled. In the double-blind phase (Part A), a total of 18 patients were enrolled at 3 dose levels. Part A was completed in October 2011. In Part B, 30 patients will be enrolled at 2 dose levels. Part B is open-label and is currently enrolling.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Idiopathic Pulmonary Fibrosis
Keywords
Fibrosis, Pulmonary Fibrosis, Lung Diseases, Interstitial

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
48 (Actual)

8. Arms, Groups, and Interventions

Arm Title
GS-6624 125mg
Arm Type
Experimental
Arm Title
Experimental: GS-6624 200mg
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GS-6624
Other Intervention Name(s)
AB0024
Intervention Description
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Primary Outcome Measure Information:
Title
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
Description
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 after multiple intravenous (IV) administrations in subjects with idiopathic pulmonary fibrosis (IPF).
Time Frame
113 days
Secondary Outcome Measure Information:
Title
- To evaluate the formation of anti-GS-6624 antibodies. - To assess the effects of GS-6624 treatment on force vital capacity (FVC) and carbon dioxide diffusing capacity (DLCO) - To assess the effects of GS-6624 treatment on SGRQ
Description
Secondary Endpoints: Anti-GS-6624 antibody formation; Change in FVC and DLCO; Change in SGRQ score.
Time Frame
113 Days

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Acceptable results on pulmonary function tests At rest oxygen saturation ≥90% on room air Adequate organ function Exclusion Criteria: High resolution computer tomography pattern showing emphysema that is greater than fibrosis Acceptable results on whole body plethysmography History of clinically significant hepatic or renal disease Poorly controlled or severe diabetes mellitus Use of systemic immunosuppressants within 28 days of GS-6624 infusion
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zung Thai, MD
Organizational Affiliation
Gilead Sciences
Official's Role
Study Director
Facility Information:
Facility Name
Arizona Pulmonary Specialists
City
Scottsdale
State/Province
Arizona
ZIP/Postal Code
85258
Country
United States
Facility Name
David Geffen School of Medicine at UCLA
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
Loess Hills Clinical Research Center
City
Council Bluffs
State/Province
Iowa
ZIP/Postal Code
51503
Country
United States
Facility Name
UPMC Translational Research Center
City
Pittsburg
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

A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis

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