At a glance
ClinicalIndex Comparison RecordStandardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Phase II, Randomized, Double-Blind, Placebo-Controlled, Study to Assess the Efficacy and Safety of Lebrikizumab in Patients With Idiopathic Pulmonary Fibrosis
In Brief
A Phase 2 clinical trial evaluating Lebrikizumab, Pirfenidone, and 1 other intervention for Idiopathic Pulmonary Fibrosis. Completed, enrolled 505 participants across 112 sites in 13 countries.
Detailed 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.
Study Details
Timeline
Interventions
Lebrikizumab will be administered at a dose of 250 mg via SC injection once every 4 weeks.
Pirfenidone will be administered orally at a stable dose of 2403 mg per day or at MTD.
Placebo matched to lebrikizumab will be administered via SC injection once every 4 weeks.