Current phase II–III trials in idiopathic pulmonary fibrosis (IPF)

Mechanism of actionClinical trial identifierStudy descriptionPrimary outcome measuresPhase of developmentTreatment duration
PRM-151Recombinant form of human SAPNCT02550873Randomised, double-blind, placebo controlledChange from baseline in FVC % predII28 weeks
SimtuzumabAnti-LOX antibodyNCT01769196Randomised, double-blind, placebo-controlledThe effect of simtuzumab (GS-6624) on progression-free survivalII148 weeks
TipelukastLeukotriene antagonistsNCT02503657Randomised, double-blind, placebo controlledChange from baseline FVC at 26 weeksII26 weeks
TralokinumabAnti IL-13 antibodyNCT01629667Randomised dose-rangingChange from baseline FVC % pred at week 52II52 weeks
SAR156597Anti IL-4 and IL-13 antibodyNCT01529853Randomised, double-blind, placebo-controlledSafety/tolerability: number of participants with adverse eventsII6 weeks
LebrikizumabAnti IL-13 antibodyNCT01872689Randomised, double-blind, placebo-controlledAnnualised rate of decrease in FVC % pred over 52 weeksII52 weeks
BG00011Anti-integrin antibodyNCT03573505Randomised, double-blind, placebo-controlledYearly rate of change in FVCII52 weeks
Pamrevlumab (FG-3019)Anti-CTGF antibodyNCT01890265Randomised, double-blind, placebo-controlledChange from baseline in FVC % pred at week 48II48 weeks
PBI-4050GPR84 antagonist/GPR40 agonistNCT02538536Open-label, single arm, exploratory, observational studyNumber of subjects with abnormal laboratory values and/or adverse events that are related to treatmentII20 weeks
KD025Selective inhibitor of ROCK2NCT02688647Randomised, phase 2, open-labelChange in FVC in baseline to 24 weeksII24 weeks
CC-90001Kinase inhibitor targeting JNKsNCT03142191Randomised, double-blind, placebo-controlledPercentage point change in FVC % predII24 weeks
GLPG1690Autotaxin-LPA inhibitorNCT02738801Randomised, double-blind, parallel group, placebo-controlledSafety, tolerability, pharmacokinetic and pharmacodynamic properties of GLPG1690II12 weeks
Omipalisib/GSK2126458Inhibitor of PI3K/Akt pathwayNCT01725139Randomised, double-blind, placebo-controlledTo explore a number of doses of GSK2126458 for engagement of pharmacology after short-term dosingI7–10 days
SirolimusmTOR inhibitorNCT01462006Double-blind placebo-controlled pilot studyChange in peripheral blood concentration of CXCR4+ fibrocytes; number of subjects with drug side-effectsNA22 weeks
RituximabAntibody targeting CD20NCT01969409Randomised, double-blind, placebo-controlledTitres of anti-HEp-2 autoantibodies, by indirect immunofluorescence assays over 9 monthsII36 weeks
Co-trimoxazole or doxycyclineAntimicrobial drugsNCT02759120Randomised, un-blinded, phase IIITime to first non-elective, respiratory hospitalisation or all-cause mortalityIII9 months

SAP: serum amyloid P; FVC: forced vital capacity; LOX: lysyl oxidase; IL: interleukin; CTGF: connective tissue growth factor; GPR: G protein-coupled receptor; ROCK: ρ-associated coiled-coil containing protein kinase; JNK: Jun N-terminal kinase; LPA: lysophosphatidic acid; PI3K/Akt: phosphoinositide 3-kinase/protein kinase B. mTOR: mammalian target of rapamycin; CXCR: C-X-C chemokine receptor; HEp: human epithelial cell.