Study to Assess the Efficacy and Safety of Simtuzumab (GS-6624) in Adults With Idiopathic Pulmonary Fibrosis (IPF)
Summary
The primary objectives of this study are to determine the effect of simtuzumab (GS-6624) on progression-free survival (PFS) as determined by either a categorical decline in forced vital capacity (FVC) or all-cause mortality, in all participants enrolled or in a subset of participants who are classified as lysyl oxidase-like-2 (LOXL2) high based on a prespecified level in serum at baseline.
Timeline
- Start
- 2013-01-31
- Primary completion
- 2016-02-23
- Completion
- 2016-02-23
Outcome
Missed primary endpoint
Stopped: “The Study was terminated due to lack of efficacy.”
registry analysis (superiority test); Simtuzumab vs Simtuzumab Placebo; p = 0.329; Hazard Ratio (HR) 1.13 (95% CI 0.88 to 1.45); Log Rank NCT01769196 ↗
registry analysis (superiority test); Simtuzumab vs Simtuzumab Placebo; p = 0.851; Hazard Ratio (HR) 1.03 (95% CI 0.74 to 1.43); Log Rank NCT01769196 ↗
registry analysis (superiority test); Simtuzumab vs Simtuzumab Placebo; p = 0.475; Hazard Ratio (HR) 1.20 (95% CI 0.72 to 2.00); Log Rank NCT01769196 ↗
Publications
- Background Raghu G, Brown KK, Collard HR, Cottin V, Gibson KF, Kaner RJ, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whelan TP, Wuyts W, Moreau E, Patterson SD, Smith V, Bayly S, Chien JW, Gong Q, Zhang JJ, O'Riordan TG. Efficacy of simtuzumab versus placebo in patients with idiopathic pulmonary fibrosis: a randomised, double-blind, controlled, phase 2 trial. Lancet Respir Med. 2017 Jan;5(1):22-32. doi: 10.1016/S2213-2600(16)30421-0. Epub 2016 Dec 7.
- Results Humphries SM, O'Riordan TG, Zhang JJ, Bayly S, Sood R, Hayden A, Lynch DA; Relationship Baseline Fibrosis Score to Lung Function in A Clinical Trial Population with Idiopathic Pulmonary Fibrosis. ATS International Conference, 2016 May 13-18, San Francisco CA.
- Results Raghu G, Brown K, Collard H, Lederer D, Martinez F, Noble P, Song JW, Wells A, Whelan T, Moreau E, Patterson S, Bayly S, Chien J, Zhang J, O'Riordan T; Simtuzumab in Idiopathic Pulmonary Fibrosis: Results of a Randomized Clinical Trial. ERS Congress, 2016 September 3-7, London, UK.
- Results Raghu G, Brown KK, Collard HR, Lederer DJ, Martinez FJ, Noble PW, Song JW, Wells AU, Whalen TP, Lambert L, Chien JW, Zhang JJ, O'Riordan TG; Simtuzumab in Idiopathic Pulmonary Fibrosis (IPF): Baseline Demographic and Lung Function Data from a Clinical Trial. ATS International Conference, 2016 May 13-18, San Francisco CA.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Simtuzumab | Monoclonal antibody | 125 mg/ml | Subcutaneous |