Clinical trial NCT01362231: A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Official title: A Phase 1 Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of GS-6624 in Adult Subjects With Idiopathic Pulmonary Fibrosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
Conditions: Idiopathic Pulmonary Fibrosis
Keywords: Fibrosis
Pulmonary Fibrosis
Lung Diseases
Interstitial
Lead sponsor: Gilead Sciences
Sponsor class: INDUSTRY
First posted: 2011-05-30
Enrollment: 48
Sex: ALL
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: BASIC_SCIENCE

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.

Eligibility 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

Primary outcomes:
measure: To characterize the safety, tolerability, and pharmacokinetics (PK) of GS-6624
timeFrame: 113 days
Secondary outcomes:
measure: - 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
timeFrame: 113 Days
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arizona Pulmonary Specialists
state: Arizona
city: Los Angeles
country: United States
facility: David Geffen School of Medicine at UCLA
state: California
city: Stanford
country: United States
facility: Stanford University Medical Center
state: California
city: Council Bluffs
country: United States
facility: Loess Hills Clinical Research Center
state: Iowa
city: Pittsburg
country: United States
facility: UPMC Translational Research Center
state: Pennsylvania
city: Charleston
country: United States
facility: Medical University of South Carolina
state: South Carolina
city: Nashville
country: United States
facility: Vanderbilt University Medical Center
state: Tennessee
Study officials:
affiliation: Gilead Sciences
name: Zung Thai, MD
role: STUDY_DIRECTOR
References: