Table 2.

Ongoing and Recently Completed Phase II/III Trials in Idiopathic Pulmonary Fibrosis

Agent	Hypothesized Mechanism of Action	Clinical Trial, Name and clinicaltrials.gov Identifier	Study Design/Sample Size, Planned or Enrolled	Primary Endpoint	Status	Estimated Primary Completion
Tralokinumab	IL-13 monoclonal antibody	NCT01629667	Phase II, randomized, double-blind, dose-ranging, placebo-controlled trial; n = 302	Δ FVC % predicted at 72 wk	Recruiting	January 2016
Lebrikizumab	IL-13 monoclonal antibody	NCT01872689	Phase II, randomized, double-blind, placebo-controlled trial; n = 250	Progression-free survival at 130 wk	Recruiting	August 2016
Pirfenidone	Antifibrotic, antiinflammatory, antioxidant	ASCEND NCT01366209	Phase III, randomized, double-blind, placebo-controlled trial; n = 555	Δ FVC % predicted at 52 wk	Completed (5)	N/A
Nintedanib	Tyrosine kinase inhibitor targeting VEGFR, FGFR, PDGFR	INPULSIS-1 NCT01335464, INPULSIS-2 NCT01335477	Phase III, randomized, double-blind, placebo-controlled trials; n = 1,066	Annual rate of decline in FVC over 52 wk	Completed (4)	N/A
STX-100	Integrin αvβ6 monoclonal antibody	NCT01371305	Phase II, randomized, double-blind, dose-escalation study; n = 32	Incidence and severity of adverse events	Recruiting	Unknown
FG-3019 (FibroGen)	CTGF inhibitor	NCT01262001	Phase II, open-label, dose-escalation study; n = 42	Safety and tolerability	Ongoing (fully recruited)	April 2018
		NCT01890265	Phase II, randomized, double-blind, placebo-controlled trial; n = 90	Δ FVC % predicted at 48 wk	Recruiting	July 2016
BMS-986020	Lysophosphatidic acid receptor antagonist	NCT01766817	Phase II, randomized, double-blind, placebo-controlled trial; n = 300	Δ FVC % predicted at 26 wk	Recruiting	April 2016
Simtuzumab	LOXL2 monoclonal antibody	NCT01769196	Phase II, randomized, double-blind, placebo-controlled trial; n = 500	Progression-free survival* up to 182 wk	Recruiting	February 2018

Definition of abbreviations: ASCEND = Assessment of Pirfenidone to Confirm Efficacy and Safety in Idiopathic Pulmonary Fibrosis; CTGF = connective tissue growth factor; FGFR = fibroblast growth factor receptor; INPULSIS = Efficacy and Safety of BIBF 1120 at High Dose in Idiopathic Pulmonary Fibrosis Patients; PDGFR = platelet-derived growth factor receptor; VEGFR = vascular endothelial growth factor receptor.

^*Progression defined as a categorical decrease in FVC % predicted (>10% relative decrease in FVC or >5% absolute decrease in FVC).