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

NCT01362231 | Completed Phase 1 DMC

• 1 other identifier: AB0024-201
• Study Type: interventional
• Target: 48
• Locations: 1 country
• Sites: 7

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.

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Fibrosis; Pulmonary Fibrosis; Lung Diseases; Interstitial

Outcome Measures

Primary Outcomes (1)

• 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).

  113 days

Secondary Outcomes (1)

• - 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

  113 Days

Study Arms (2)

GS-6624 125mg

EXPERIMENTAL

Drug: GS-6624

Experimental: GS-6624 200mg

EXPERIMENTAL

Drug: GS-6624

Interventions

GS-6624 DRUG

Patients will be treated with GS-6624 (125 or 200 mg) administered IV over 1 hour on specific days during the treatment period.

Also known as: AB0024

Experimental: GS-6624 200mg; GS-6624 125mg

Eligibility Criteria

• Age: 40 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Acceptable results on pulmonary function tests
• At rest oxygen saturation ≥90% on room air
• Adequate organ function

You may not qualify if:

• 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

Sponsors & Collaborators

• Gilead Sciences: lead

Study Sites (7)

Arizona Pulmonary Specialists

Scottsdale, Arizona, 85258, United States

Location

David Geffen School of Medicine at UCLA

Los Angeles, California, 90095, United States

Location

Stanford University Medical Center

Stanford, California, 94305, United States

Location

Loess Hills Clinical Research Center

Council Bluffs, Iowa, 51503, United States

Location

UPMC Translational Research Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Medical University of South Carolina

Charleston, South Carolina, 29425, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37232, United States

Location

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Fibrosis; Pulmonary Fibrosis; Lung Diseases

Interventions

simtuzumab

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Respiratory Tract Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Zung Thai, MD

  Gilead Sciences

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 12, 2011
• First Posted: May 30, 2011
• Study Start: December 1, 2010
• Primary Completion: December 1, 2012
• Study Completion: December 1, 2012
• Last Updated: July 9, 2015

Record last verified: 2015-07

Locations

US (7)