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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Gilead Sciences
ClinicalTrials.gov Identifier:
NCT01362231
First received: April 12, 2011
Last updated: February 26, 2013
Last verified: February 2013
  Purpose

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.


Condition Intervention Phase
Idiopathic Pulmonary Fibrosis
Drug: GS-6624
Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Basic Science
Official Title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis

Resource links provided by NLM:


Further study details as provided by Gilead Sciences:

Primary Outcome Measures:
  • To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624 [ Time Frame: 113 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 113 Days ] [ Designated as safety issue: Yes ]

    Secondary Endpoints:

    • Anti-GS-6624 antibody formation;
    • Change in FVC and DLCO;
    • Change in SGRQ score.


Enrollment: 48
Study Start Date: December 2010
Study Completion Date: December 2012
Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: GS-6624 125mg Drug: GS-6624
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Other Name: AB0024
Experimental: Experimental: GS-6624 200mg Drug: GS-6624
Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.
Other Name: AB0024

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.

  Eligibility

Ages Eligible for Study:   40 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
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, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01362231

Locations
United States, Arizona
Arizona Pulmonary Specialists
Scottsdale, Arizona, United States, 85258
United States, California
David Geffen School of Medicine at UCLA
Los Angeles, California, United States, 90095
Stanford University Medical Center
Stanford, California, United States, 94305
United States, Iowa
Loess Hills Clinical Research Center
Council Bluffs, Iowa, United States, 51503
United States, Pennsylvania
UPMC Translational Research Center
Pittsburg, 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: Zung Thai, MD Gilead Sciences
  More Information

No publications provided

Responsible Party: Gilead Sciences
ClinicalTrials.gov Identifier: NCT01362231     History of Changes
Obsolete Identifiers: NCT01242189
Other Study ID Numbers: AB0024-201
Study First Received: April 12, 2011
Last Updated: February 26, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Gilead Sciences:
Fibrosis
Pulmonary Fibrosis
Lung Diseases, Interstitial

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

ClinicalTrials.gov processed this record on August 28, 2014