A Study of Lebrikizumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

Phase 2 Completed 505 enrolled Hoffmann-La Roche

RandomizedParallel-groupDouble-blindTreatment

Summary

This randomized, multicenter, double-blind, placebo-controlled, parallel-group study will evaluate the efficacy and safety of lebrikizumab as monotherapy in the absence of background IPF therapy and as combination therapy with pirfenidone background therapy in participants with IPF. Participants will be randomized to receive either lebrikizumab or placebo subcutaneously every 4 weeks.

Timeline

Start: 2013-10-13
Primary completion: 2017-07-28
Completion: 2017-11-06

Outcome

Missed primary endpoint

registry p = 0.4555; Median Difference (Final Values) 0.98111 (95% CI -1.61 to 3.57) NCT01872689 ↗

registry p = 0.5566; Mean Difference (Final Values) 0.49998 (95% CI -1.17 to 2.17) NCT01872689 ↗

Publications

Allen RJ, Stockwell A, Oldham JM, Guillen-Guio B, Schwartz DA, Maher TM, Flores C, Noth I, Yaspan BL, Jenkins RG, Wain LV; International IPF Genetics Consortium. Genome-wide association study across five cohorts identifies five novel loci associated with idiopathic pulmonary fibrosis. Thorax. 2022 Aug;77(8):829-833. doi: 10.1136/thoraxjnl-2021-218577. Epub 2022 Jun 10.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Lebrikizumab	Monoclonal antibody	250 mg	Subcutaneous
Background	Pirfenidone	Small molecule	2403 mg	Oral