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

Phase 1

Completed

• Conditions: Idiopathic Pulmonary Fibrosis
• Interventions: Drug: GS-6624

• Registration Number: NCT01362231
• Lead Sponsor: Gilead Sciences

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.

Study Timeline

• Study Start: 2010-12
• Study First Submitted: 2011-04-12
• Study First Submitted QC: 2011-05-27
• Study First Posted: 2011-05-30
• Primary Completion: 2012-12
• Study Completion: 2012-12
• Status Verified: 2015-07
• Last Update Submitted: 2015-07-07
• Last Update Posted: 2015-07-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
GS-6624 125mg	GS-6624	-
Experimental: GS-6624 200mg	GS-6624	-

Primary Outcome Measures

Name	Time	Method
To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624	113 days	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

Name	Time	Method
- 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	Secondary Endpoints: * Anti-GS-6624 antibody formation; * Change in FVC and DLCO; * Change in SGRQ score.

Trial Locations

Locations (7)

Loess Hills Clinical Research Center; 🇺🇸 Council Bluffs, Iowa, United States

Stanford University Medical Center; 🇺🇸 Stanford, California, United States

Medical University of South Carolina; 🇺🇸 Charleston, South Carolina, United States

David Geffen School of Medicine at UCLA; 🇺🇸 Los Angeles, California, United States

UPMC Translational Research Center; 🇺🇸 Pittsburg, Pennsylvania, United States

Vanderbilt University Medical Center; 🇺🇸 Nashville, Tennessee, United States

Arizona Pulmonary Specialists; 🇺🇸 Scottsdale, Arizona, United States