A Study to Evaluate the Safety and Efficacy of GS-6624 (Formerly AB0024) in Patients With Idiopathic Pulmonary Fibrosis
Status and phase
Conditions
Treatments
Details and patient eligibility
About
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.
Full 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.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
- Acceptable results on pulmonary function tests
- At rest oxygen saturation ≥90% on room air
- Adequate organ function
Exclusion criteria
- 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
Trial design
Primary purpose
Allocation
Interventional model
Masking
48 participants in 2 patient groups
Trial contacts and locations
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Data sourced from clinicaltrials.gov
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