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

Gilead Sciences48 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

NONE

Enrollment

Conditions

Idiopathic Pulmonary Fibrosis

Interventions

GS-6624DRUG

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

Eligibility

Sex: ALLMin age: 40 YearsMax age: 85 Years

Medical Language ↔ Plain English

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

Locations (7)

Arizona Pulmonary Specialists

Scottsdale, Arizona, United States

David Geffen School of Medicine at UCLA

Los Angeles, California, United States

Stanford University Medical Center

Stanford, California, United States

Loess Hills Clinical Research Center

Council Bluffs, Iowa, United States

Outcomes

Primary Outcomes

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).

Time frame: 113 days

Secondary Outcomes

- 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.

Time frame: 113 Days

Data from ClinicalTrials.gov

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