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

Idiopathic Pulmonary Fibrosis Clinical Trial

Official title:

A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01362231
• Other study ID #: AB0024-201
• Status: Completed
• Phase: Phase 1
• First received: April 12, 2011
• Last updated: July 7, 2015
• Start date: December 2010
• Est. completion date: December 2012

Study information

• Verified date: July 2015
• Source: Gilead Sciences
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Other known NCT identifiers

• NCT01242189

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 40 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Fibrosis
• Idiopathic Interstitial Pneumonias
• Idiopathic Pulmonary Fibrosis
• Pulmonary Fibrosis

Intervention

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.

Locations

Country	Name	City	State
United States	Medical University of South Carolina	Charleston	South Carolina
United States	Loess Hills Clinical Research Center	Council Bluffs	Iowa
United States	David Geffen School of Medicine at UCLA	Los Angeles	California
United States	Vanderbilt University Medical Center	Nashville	Tennessee
United States	UPMC Translational Research Center	Pittsburg	Pennsylvania
United States	Arizona Pulmonary Specialists	Scottsdale	Arizona
United States	Stanford University Medical Center	Stanford	California

Sponsors (1)

Lead Sponsor	Collaborator
Gilead Sciences

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Yes
Secondary	- 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.	113 Days	Yes